Registration Dossier
Registration Dossier
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EC number: 200-157-7 | CAS number: 52-89-1
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- 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
- Year:
- 2 013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
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:
- 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: 8 weeks
- Weight at study initiation: 185 - 209 g
- Fasting period before study: 4 hours
- Housing: by 3 in solid-bottomed clear polycarbonate cages with astainless steel mesh lid.
- Diet: ad libitum, A04, SAFE
- Water: tap-water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25 °C
- Humidity (%): 30 - 70
- Air changes (per hr): 10 - 15 per hour
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Amount of vehicle: 10 ml/kg bw. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observation, weighing on day 0, 2, 7 and on day 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, daily - Statistics:
- no
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD0
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- act. ingr.
- Remarks on result:
- other: no toxicity observed
- Mortality:
- no
- Clinical signs:
- other: no
- 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 oral route in the rat.
- Executive summary:
L-Cysteine hydrochloride monohydrate was administered to a group of 6 female Sprague-Dawley rats at a single oral dose of 2000 mg/kg bw. in 10 ml/kg bw. distilled water by stomach tube.
No moraltity, no clinical signs and no changed body weight evolution were found during the 14 day observation period. The macroscopic examination of the animals at the end of the study did not reveal treatment related changes.
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