Registration Dossier

Diss Factsheets

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Polysulfides, di-tert-Bu
EC Number:
273-103-3
EC Name:
Polysulfides, di-tert-Bu
Cas Number:
68937-96-2
Molecular formula:
not applicable
IUPAC Name:
Polysulfides, di-tert-Bu
Details on test material:
Source: SNEA(P)
Batch: D9512A
Sulfur content 44.96%.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system 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

Administration / exposure

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.

Results and discussion

Effect levels
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.

Applicant's summary and conclusion

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.

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