Dr.Storch-Recherchen: Sodiumhydrogensulphate

Dienstag, 23. Februar 2016

Guidance on safe use

Guidance on safe use


Administrative data

First-aid measures

4.1 General information
Move victim out of danger zone. Position and transport victim on their side. In case of respiratory distress, bring into semi-upright, seated position. Remove contaminated clothing immediately and dispose off safely. Put victim at rest, cover with a blanket and keep warm. Do not leave victim unattended. In case of accident or if you feel unwell, seek medical advice immediately (show safety data sheet if possible).
Medical treatment necessary.

4.2 In case of inhalation
Provide fresh air. In case of breathing difficulties administer oxygen. No mouth-to mouth or mouth-to-nose resuscitation. Use respiratory bag or oxygen resuscitation apparatus.

4.3 In case of skin contact
Remove contaminated clothing immediately and dispose off safely. After contact with skin, wash immediately with plenty of water.

4.4 In case of eye contact
If product gets into the eye, keep eyelid open and rinse immediately with large quantities of water, for at least 5 minutes. Subsequently consult an ophthalmologist. Protect the eye that is not injured.

4.5 In case of ingestion
Rinse mouth immediately and drink large quantities of water. Do not induce vomiting.

4.6 Self-protection of the first aider
First aid assistant: Pay attention to self-protection!

4.7 Information to physician
4.7.1 Routes of exposure
The substance can be absorbed into the body by inhalation of its dust and by ingestion.
4.7.2 Hazards
Effects of short-term exposure: The substance irritates the eyes, the skin and the respiratory tract. 
Effects of long-term or repeated exposure: -
Notes: -
4.7.3 Symptoms
In case of inhalation: cough, shortness of breath, sore throat, laboured breathing.
In case of skin contact: redness, pain, blisters
In case of eye contact: redness, pain
In case of ingestion: abdominal pain, burning sensation
4.7.4 Treatment
First aid, decontamination, treatment of symptoms.

Fire-fighting measures

5.1 Suitable extinguishing media
Water spray jet, water mist, foam, carbon dioxide (CO2), extinguishing powder.

5.2 Extinguishing media which must not be used for safety reasons: full water jet.

5.3 Special exposure hazards arising from the substance or preparation itself, combustion products, resulting gases.
In case of fire may be liberated: sulphur dioxide (SO2), sulphur trioxide.

5.4 Special protective equipment for fire-fighters
Wear full chemical protective clothing. In case of fire: Wear self-contained breathing apparatus.

5.5 Additional information
Intervention Actions-General: keep upwind, put on protective equipment before entering danger area.
Intervention Actions-Fire (involving the substance): heating of container(s) will cause pressure rise with risk of bursting and subsequent explosion. Gives off toxic and irritant fumes when heated or burning. May attack metals and produce hydrogen gas which may form explosive mixture with air. The vapour may be invisible and is heavier than air. It spreads along the ground and may enter sewers and basements. Keep container(s) cool with water. Extinguish with water fog (spray). Do not use water jet to extinguish. Use water spray to knock down fire fumes if possible. Avoid unnecessary run-off of extinguishing media which may cause pollution.
ERI-Card

Accidental release measures

6.1 Personal precautions (spillage): wear personal protection equipment.

6.2 Environmental precautions: stop leaks if possible, contain spillage by any means available.

6.3 Methods for cleaning up: refer to chapter 6.4

6.4 Additional information: sweep spilled substance into containers; if appropriate, moisten first to prevent dusting. Wash away remainder with plenty of water. Personal protection: P2 filter respirator for harmful particles.

Handling and storage

7.1 Handling
7.1.1 Advices on safe handling
Protective measures: wear personal protection equipment, refer to chapter 8. 
Do not eat, drink, smoke or sneeze at the workplace. Dangerous areas must be delimited and marked with appropriate warning and safety signs. In the immediate working surroundings there must be: emergency spray installed. Provide eye wash and label its location conspicuously. Provide sufficient washing facilities. Fill only into labelled container. Instruction on the hazards and the protective measures using instruction manual are required with signature. Working areas must be arranged in such a manner that they can be cleaned at all times.

7.1.2 Technical measures
Measures to prevent aerosol and dust generation
It is recommende to design all work processes always so that the following is excluded: Inhalation. Skin contact. Eye contact. If handled uncovered, arrangements with local exhaust ventilation should be used if possible.
Measures required to protect the environment
No special environmental protection measures are necessary.

7.1.3 Specific requirements or handling rules
The floor should be leak tight, jointless and not absorbent.

7.1.4 Precautions against fire and explosion
Usual measures for fire prevention.

7.2 Storage
7.2.1 Technical measures and storage conditions
Keep container tightly closed. Keep/Store only in original container.
Protect against: Humidity. UV-radiation/sunlight.

7.2.2 Hints on storage assembly
Keep away from food, drink and animal feedingstuffs.

7.2.3 Further information on storage conditions
Storage class 8 B nicht brennbare ätzende Stoffe
Storage temperature 10 °C – 30 °C
Relative air humidity 10 – 55 %
Maximum period of storage 2 Jahre / years / Años / ans / anni / jaren

Transport information

Shippingopen allclose all

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Basic toxicokinetics.001,004,005

Basic toxicokinetics.005

Administrative data

Purpose flag:
key study
Study result type:
read-across from supporting substance (structural analogue or surrogate)
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
non-standard study

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1979

Materials and methods

Objective of study
Objective of study:
absorption

Test materials

Identity of test material same as for substance defined in section 1 (if not read-across):
no
Test material identityopen allclose all

Test material identity 1

Test material identity 2

Test material identity 3

Test animals

Species:
rat

Results and discussion

Pharmacokinetic studies

Toxicokinetic parametersopen allclose all

Toxicokinetic parameters 1

Toxicokinetic parameters 2

Toxicokinetic parameters 3

Metabolite characterisation studies

Metabolites identified:
no
Details on metabolites:
not relevant

Bioaccessibility

Any other information on results incl. tables:
RS-Freetext: 
Absorption of inorganic sulfate after ingestion in rats 
(male, Wistar (30-330 g body weight) was investigated. A 
inorganic sulfate concentration was measured in the serum 
after 2 hours of oral administration of 5 mmol Na2SO4. A 
threefold increase in serum sulfate concentration was 
measured. Complete absorption from the gastrointestinal tract 
was measured using 35S labelled sulfate.

Applicant's summary and conclusion


****************************************************

Basic toxicokinetics.004

Administrative data

Purpose flag:
key study
Study result type:
read-across from supporting substance (structural analogue or surrogate)
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
non-standard study

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1981

Materials and methods

Methods:
in vivo
GLP compliance:
no
Objective of study
Objective of study:
absorption

Test materials

Identity of test material same as for substance defined in section 1 (if not read-across):
no
Test material identityopen allclose all

Test material identity 1

Test material identity 2

Test material identity 3

Identifier:
EC name
Identity:
sodium sulphate
Details on test material:
IUCLID4 Test substance: as prescribed by 1.1 - 1.4

Test animals

Species:
other: homo sapiens

Administration / exposure

Route of administration:
oral: unspecified
Doses / concentrations:
Males: 18.1 g Na2SO4 decahydrate (800 g of the anhydrous salt)
No. of animals per sex per dose:
Males: 5 Females: 0

Results and discussion

Pharmacokinetic studies

Toxicokinetic parametersopen allclose all

Toxicokinetic parameters 1

Toxicokinetic parameters:
Half-life 1st:

Toxicokinetic parameters 2

Toxicokinetic parameters:
Half-life 2nd:

Toxicokinetic parameters 3

Toxicokinetic parameters:
Half-life 3rd:

Bioaccessibility

Any other information on results incl. tables:
RS-Freetext: 
Prior to exposure  three  separate  24-hour periods for 
urine volume and baseline sulfate excretion determination 
(twice, one -week interval). Subjects received either above 
dose in a single dose or in four hourly increments; one week 
later the alternative dosing schedule. 
72 -hour urine was collected in 24-hour portions. Urinary 
free sulfate excretion corrected for baseline was about 53.4 
+-16.8 for the single dose and 61.8 +-7.8 for the divided 
dose. Single dose causeds severe diarrhoea, divided dose did 
not.  Excretion of free sulfate is not influenced by urine 
flow, but excretion of organicaly bound sulfate is.in a 
linear fashion.

Applicant's summary and conclusion

Conclusions:
Sodium sulfate is better absorbed from the intestine when given in divided dose than from a single large dose, indicating saturation of the transport system.



*************************************************

Basic toxicokinetics.001

Administrative data

Purpose flag:
key study
Study result type:
read-across from supporting substance (structural analogue or surrogate)
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
non-standard study

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1976

Materials and methods

Methods:
in vivo
GLP compliance:
no
Objective of study
Objective of study:
distribution

Test materials

Details on test material:
IUCLID4 Test substance: other TS: Na2SO4 (35S-labeled)

Test animals

Species:
other: homo sapiens

Administration / exposure

Route of administration:
other: intravenously and oral
Doses / concentrations:
Males: 60-80 microCurie
No. of animals per sex per dose:
Males: 8 Females: 0

Results and discussion

Pharmacokinetic studies

Toxicokinetic parametersopen allclose all

Toxicokinetic parameters 1

Toxicokinetic parameters:
Half-life 1st:

Toxicokinetic parameters 2

Toxicokinetic parameters:
Half-life 2nd:

Toxicokinetic parameters 3

Toxicokinetic parameters:
Half-life 3rd:

Bioaccessibility

Any other information on results incl. tables:
RS-Freetext: 
Volunteers received above dose IV, followed by 24-hours 
fluid restriction and blood and urine collection to 
determine radio-activity and creatinine concentration 
Same volunteers received same amount orally 14 days later, 
followed by same regimen. 
Plasma equilibrium iwas reached within 90 and 105 minutes 
respectively. 
Calculated mean extracelluar fluid space was 16.8 +- 1.1 and 
15.3 +- 1.2 respectively or only 9%. 
Conclusion: 35S-labeled sulfate is absorbed completely and 
rapidly.

Applicant's summary and conclusion

Conclusions:
35S-labeled sulfate is absorbed completely and rapidly.



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Toxicological Informations


  • Toxicological Informations

  • Toxicological Summary
  • Toxicokinetics, metabolism and distribution
    • Endpoint summary
    • Basic toxicokinetics
    • Dermal absorption
  • Acute Toxicity
    • Endpoint summary
    • Acute Toxicity: oral
    • Acute Toxicity: inhalation
    • Acute Toxicity: dermal
    • Acute Toxicity: other routes
  • Irritation / corrosion
    • Endpoint summary
    • Skin irritation / corrosion
    • Eye irritation
  • Sensitisation
    • Endpoint summary
    • Skin sensitisation
    • Respiratory sensitisation
  • Repeated dose toxicity
    • Endpoint summary
    • Repeated dose toxicity: oral
    • Repeated dose toxicity: inhalation
    • Repeated dose toxicity: dermal
    • Repeated dose toxicity: other routes
  • Genetic toxicity
  • Carcinogenicity
  • Toxicity to reproduction
  • Specific investigations
  • Exposure related observations in humans
  • Toxic effects on livestock and pets
  • Additional 
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