Registration Dossier
Registration Dossier
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EC number: 200-157-7 | CAS number: 52-89-1
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012-11-20 to 2013-01-18
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
Test material
- Reference substance name:
- L-Cysteine Hydrochloride Monohydrate
- Cas Number:
- 175.63
- Molecular formula:
- C3H7NO2S·HCl·H2O
- IUPAC Name:
- L-Cysteine Hydrochloride Monohydrate
- Test material form:
- solid: granular
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage Janvier, F-53940 Le Genest St Isle, France
- Age at study initiation: males: 7 weeks, females 8 weeks
- Weight at study initiation: males: 230 - 247 g, females 215 - 230 g
- Fasting period before study: no
- Housing: during the treatment kept in individual cages. In D1, the animals were put into their cage by 5.
- Diet: ad libitum, SAFE - A04
- Water: tap water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25 °C
- Humidity (%): 30 - 70
- Air changes (per hr): 10 -15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- water
- Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- act. ingr.
- Remarks on result:
- other: no treatment-related changes observed
- Mortality:
- no
- Clinical signs:
- other: no treatment-related changes
- Gross pathology:
- no treatment-related changes
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 of the test item L-Cysteine hydrochloride monohydrate is higher than 2000 mg/kg bw. by
dermal route in the rat. - Executive summary:
L-Cysteine hydrochloride monohydrate was applied to the skin of 5 male and 5 female Sprague-Dawley rats at a dose of 2000 mg/kg bw.in 10 ml/kg bw water for 24 hours in an occlusive way. After 24 hours the gauze dressings were removed. The animals were observed for 14 days.
No mortality, no clinical signs, no influence on the body weight evolution and no macroscopic findings at the end of the study were seen.
The LD50 is higher than 2000 mg/kg bw.
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