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Administrative data

Description of key information

Polysulfides, di-tert-butyl are of low acute toxicity by the oral and dermal routes with LD0s at 2000 mg/kg (LD50s >= 2000 mg/kg).

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Iffa Crédo, 69120 L'Arbresle, France
- Age at study initiation: 6-week old
- Weight at study initiation: 182 +/- 15g for the males and 138 +/- 4 g for the females
- Fasting period before study: 18 hours
- Housing: in groups of 5 per sex in polycarbonate cages
- Diet (e.g. ad libitum): Rats - Mice sustenance ref A04 (UAR, France)
- Water (e.g. ad libitum): filtered tap water
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 50 +/- 20
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
The test substance was administered by oral route to a group of 10 fasted Sprague-Dawley rats (5 males and 5 females). The test substance was administered in its original form at a dose level of 2000 mg/kg at a volume taking into consideration that the specific gravity (SG) of the test substance was 1.007.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
The mortality, general behaviour and body weight gain of the animals were observed for a period of 14 days after the single administration of the test substance. A necropsy was performed on each animal sacrificed at the end of the study.
Key result
Sex:
male/female
Dose descriptor:
LD0
Effect level:
2 000 mg/kg bw
Mortality:
No deaths occurred at the dose level of 2000 mg/kg.
Clinical signs:
A slight to well-defined decrease in spontaneous activity and respiratory difficulties were observed in all animals within the hours following the treatment. From day 2 to day 15, the general behaviour was normal.
Body weight:
The body weight gain of the animals was not influenced by the treatment.
Gross pathology:
The macroscopic examination revealed no abnormalities in the animal sacrificed at the end of the study.
Interpretation of results:
GHS criteria not met
Conclusions:
The LD0 of TPS 44 administered by oral route in rats was 2000 mg/kg.
Executive summary:

The potential acute toxicity of TPS 44 was evaluated in rats according to the recommendations of the O.E.C.D. Guideline No. 401 (O.E.C.D., 24th February 1987) for the testing of chemicals administered by oral route and the Principles of Good Laboratory Practice (O.E.C.D., 12th May 1981). TPS 44 was administered by oral route to a group of 10 fasted Sprague-Dawley rats (5 males and 5 females). TPS 44 was administered in its original form at a dose level of 2000 mg/kg at a volume taking into consideration that the specific gravity (SG) of TPS 44 was 1.007. The mortality, general behaviour and body weight gain of the animals were observed for a period of 14 days after the single administration of TPS 44. A necropsy was performed on each animal sacrificed at the end of the study.

A slight to well-defined decrease in spontaneous activity and respiratory difficulties were observed in all animals within the hours following the treatment. From day 2 to day 15, the general behaviour returned was normal. No deaths occurred at the dose level of 2000 mg/kg. The body weight gain of the animals was not influenced by the treatment. The macroscopic examination revealed no abnormalities in the animal sacrificed at the end of the study.

Under these experimental conditions, the LD0 of TPS 44 administered by oral route in rats was 2000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Iffa Créco (69210 L'Arbresle, France)
- Age at study initiation: 8-week old
- Weight at study initiation: 270 +/- 10 g for males and 215 +/- 9 g for females
- Fasting period before study: not appropriate
- Housing: polycarbonate cages
- Diet (e.g. ad libitum): AO4C (UAR, 91360 Villemoisson/Orge, France)
- Water (e.g. ad libitum): filtered tap water
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 50 +/- 20
- Air changes (per hr): 13
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
The test substance was administered by dermal route to a group of 10 Sprague-Dawley rats (5 males and 5 females). The test substance in its original form was applied directly to the skin at a dose of 2000 mg/kg, taking into consideration that the specific gravity (SG) of the test substance was 1.007. After 24 hours under a semi-occlusive dressing, no residual test substance was observed on removal of the dressing.
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
The animals were checked for clinical signs, mortality and body weight gain for a period of 14 days following the single application of the test substance. A necropsy was performed on each animal sacrificed at the end of the study.
Key result
Sex:
male/female
Dose descriptor:
LD0
Effect level:
2 000 mg/kg bw
Remarks on result:
other: No mortality, clinical sign and cutaneous reaction
Mortality:
No deaths occurred at 2000 mg/kg
Clinical signs:
The general behaviour of the animals was not affected by treatment with the test substance. No cutaneous reactions were observed.
Body weight:
The body weight gain of the animals was not affected by treatment with the test substance.
Gross pathology:
A macroscopic examination revealed no abnormalities in the animals sacrificed at the end of the study.
Interpretation of results:
GHS criteria not met
Conclusions:
The LD0 of TPS 44, when administered by dermal route in rats was 2000 mg/kg. No signs of toxicity were observed at this dose.
Executive summary:

The acute toxicity of TPS 44, by dermal route was evaluated in rats according to O.E.C.D. (No. 402, 24th February 1987) guidelines. The study was conducted in compliance with the Principles of Good Laboratory Practice.

TPS 44 was administered by dermal route to a group of 10 Sprague-Dawley rats (5 males and 5 females). TPS 44 in its original form was applied directly to the skin at a dose of 2000 mg/kg, taking into consideration a specific gravity (SG) of 1.007. After 24 hours under a semi-occlusive dressing, no residual test substance was observed on removal of the dressing. The animals were checked for clinical signs, mortality and body weight gain for a period of 14 days following the single application of the test substance.

A necropsy was performed on each animal sacrificed at the end of the study.

The general behaviour and body weight gain of the animals were not affected by treatment with the test substance. No deaths occurred at 2000 mg/kg. A macroscopic examination revealed no abnormalities in the animals sacrificed at the end of the study.

The LDo of TPS 44, when administered by dermal route in rats was 2000 mg/kg. No signs of toxicity were observed at this dose.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw

Additional information

Oral route

The potential acute oral toxicity of polysulfides, di-tert-butyl was evaluated in rats according to the OECD guideline No. 401 and in compliance with GLP (Clouzeau, 1992a). Polysulfides, di-tert-butyl was administered by oral route to a group of 10 fasted Sprague-Dawley rats (5 males and 5 females). Polysulfides, di-tert-butylwas administered in its original form at a dose level of 2000 mg/kg at a volume taking into consideration that the specific gravity (SG) was 1.007. The mortality, general behaviour and body weight gain of the animals were observed for a period of 14 days after the single administration of polysulfides, di-tert-butyl. A necropsy was performed on each animal killed at the end of the study. A slight to well-defined decrease in spontaneous activity and respiratory difficulties were observed in all animals within the hours following the treatment. From day 2 to day 15, the general behaviour returned to normal. No deaths occurred at the dose level of 2000 mg/kg. The body weight gain of the animals was not influenced by the treatment. The macroscopic examination revealed no abnormalities in the animal sacrificed at the end of the study. The LD0 of polysulfides, di-tert-butyl administered by oral route in rats is 2000 mg/kg bw (LD50 =>2000 mg/kg).

Dermal route

The acute toxicity of polysulfides, di-tert-butyl by dermal route was evaluated in rats according to the OECD guideline No. 402 and in compliance with GLP (Clouzeau, 1993). Polysulfides, di-tert-butyl was administered by dermal route to a group of 10 Sprague-Dawley rats (5 males and 5 females). Polysulfides, di-tert-butyl in its original form was applied directly to the skin at a dose of 2000 mg/kg, taking into consideration a specific gravity (SG) of 1.007. After 24 hours under a semi-occlusive dressing, no residual test substance was observed on removal of the dressing. The animals were checked for clinical signs, mortality and body weight gain for a period of 14 days following the single application of the test substance. A necropsy was performed on each animal sacrificed at the end of the study. The general behaviour and body weight gain of the animals were not affected by treatment with the test substance. No deaths occurred at 2000 mg/kg. A macroscopic examination revealed no abnormalities in the animals sacrificed at the end of the study. The LD0 of polysulfides, di-tert-butyl, when administered by dermal route in rats is 2000 mg/kg (LD50 =>2000 mg/kg). No signs of toxicity were observed at this dose.

Justification for classification or non-classification

No mortality was observed in rats dosed with polysulfides, di-tert-butyl at 2000 mg/kg bw by the oral and dermal routes. Therefore, according to the EC regulation No 1272/2008, no classification is warranted.