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EC number: 202-605-7 | CAS number: 97-74-5
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
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- Stability in organic solvents and identity of relevant degradation products
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- Endpoint summary
- Stability
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- Environmental data
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
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- Toxicological Summary
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- Acute Toxicity
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- Additional toxicological data

Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 30 May 2012 - 05 July 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- no clinical signs were recorded for animal Y23853 on day 4 by mistake. This deviation was considered not to have compromised the validity or integrity of the study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- yes
- Remarks:
- no clinical signs were recorded for animal Y23853 on day 4 by mistake. This deviation was considered not to have compromised the validity or integrity of the study
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Tetramethylthiuram monosulfide
- IUPAC Name:
- Tetramethylthiuram monosulfide
- Reference substance name:
- Tetramethylthiuram monosulphide
- EC Number:
- 202-605-7
- EC Name:
- Tetramethylthiuram monosulphide
- Cas Number:
- 97-74-5
- Molecular formula:
- C6H12N2S3
- IUPAC Name:
- N,N-dimethyl[(dimethylcarbamothioyl)sulfanyl]carbothioamide
- Test material form:
- solid: particulate/powder
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: breeder: Janvier, Le Genest-Saint-Isle, France.
- Age at study initiation: approximately 8 weeks old on the day of treatment .
- Mean body weight at study initiation: the males had a mean body weight of 369 g (range: 358 g to 375 g) and the females had a mean body weight of 234 g (range: 224 g to 254 g).
- Fasting period before study: yes, during the night before treatment.
- Housing: the animals were housed by five from the same sex and group in polycarbonate cages with stainless steel lids .
- Diet: SSNIFF R/M-H pelleted diet (free access)
- Water: tap water filtered with a 0.22 µm filter (free access)
- Acclimation period: the animals were acclimated to the study conditions for a period of 6 or 9 days before treatment.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Humidity (%): 50 ± 20%
- Air changes (per hr): approximately 12 cycles/hour of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12 h/12 h.
IN-LIFE DATES: ---- to ----
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 10% of body surface, dorsal site
- Type of wrap if used: hydrophilic gauze pad + adhesive hypoallergenic aerated semi-occlusive dressing + restraining bandage
REMOVAL OF TEST SUBSTANCE
- Removal of dressing: 24h post-exposure
- Washing: at 24h post-exposure, with a moistened cotton pad
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg
- Constant volume: no
- For solids, paste formed: no - Duration of exposure:
- 24h
- Doses:
- 2000 mg/kg.
- No. of animals per sex per dose:
- 5 animals/sex per group
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Clinical observations: frequently during the hours following treatment; then, at least once a day.
- Body weight: just before treatment on day 1; then on days 8 and 15.
- Necropsy of survivors performed: yes (macroscopic). - Statistics:
- no
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No unscheduled deaths occurred during the study.
- Clinical signs:
- other: No clinical signs indicative of systemic toxicity were observed in any animals. A yellow discoloration was observed at application site of all animals between days 2 and 4. Erythema and scabs were noted in 2/5 females between days 5 and 14. Scabs were als
- Gross pathology:
- Enlarged spleen was seen in one male treated at 2000 mg/kg. In the absence of similar change in females treated at the same dose-level, this observation in a single male was considered to be unlikely test item related.
- Other findings:
- no
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The dermal LD50 of the test item was higher than 2000 mg/kg in rats.
Therefore, the test item is not classified as toxic by dermal route according to the criteria of CLP Regulation. - Executive summary:
The test item was applied in its original form to the skin of five females and then five males Sprague-Dawley rats at the dose-level of 2000 mg/kg. The application site was covered by a semi-occlusive dressing for 24 hours.
Each animal was observed at least once a day for mortality and clinical signs for 15 days. From day 2, any local reactions at the treatment site were also noted. Body weight was recorded on day 1 and then on days 8 and 15.
On completion of the observation period, the animals were sacrificed and then submitted for a macroscopicpost-mortemexamination.Macroscopic lesions were preservedin buffered formalinthendestroyed at the finalization of the study reportas no microscopic examination was performed.
No unscheduled deaths occurred during the study.
No clinical signs indicative of systemic toxicity were observed in any animals.
A yellow discoloration was observed at application site of all animals between days 2 and 4. Erythema and scabs were noted in 2/5 females between days 5 and 14. Scabs were also observed in 1/5 males on days 3 and 4.
When compared to CiToxLAB historical control data, a lower body weight gain was noted in 1/5 females (5 g, vs. 36 ± 12 g in control data base) between day 1 and day 8. In addition, a body weight loss of 1% was noted respectively in 2/5 males during the first week of observation period. Their body weight gains returned to normal thereafter.
No test item-related changes were seen at necropsy.
The dermal LD50of the test item,Tetramethylthiurammonosulfide, was higher than 2000 mg/kg in rats.
Therefore, the test item is not classified as toxic by dermal route according to the criteria of CLP Regulation.
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