Registration Dossier
Registration Dossier
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EC number: 200-158-2 | CAS number: 52-90-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD Guideline Study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- L-cysteine
- EC Number:
- 200-158-2
- EC Name:
- L-cysteine
- Cas Number:
- 52-90-4
- Molecular formula:
- C3H7NO2S
- IUPAC Name:
- L-cysteine
- Test material form:
- other: solid
- Details on test material:
- Name: L-Cysteine
Batch No.: 12030506
Physical State: white solid
Molecular Weight: 121.1
pH: 4.5-6
Purity / Active Components: 99.6%
Storage Conditions: 2-8°C, protected from light
Date of Analysis: 23.05.2012
Expiry Date: 31.03.2014
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, 97633 Sulzfeld, Germany
- Age at study initiation: approximately 14-15 weeks old
- Weight at study initiation: >2kg
- Housing: ABS - plastic rabbit cages, floor 4200 cm2
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: Adequate , at least 5 days under laboratory conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3
- Humidity (%): 55± 10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12:12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- other: aqua ad injectionem
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g per test site
VEHICLE
- Concentration (if solution): test item was moistened with vehicle to ensure good skin contact
- Lot/batch no. (if required): 10952_1 - Duration of treatment / exposure:
- 4-h period
- Observation period:
- 72h
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: left side of the dorsal area
- % coverage: approx. 6 cm²
- Type of wrap if used: gauze was held in place withnon-irritating tape; patch was fixed with a semi-occlusive dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the exposure period, the residual test item was removed with aqua ad injectionem
- Time after start of exposure: 4h
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24-72h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24-72h
- Score:
- 0
- Max. score:
- 4
- Other effects:
- Neither mortalities nor significant clinical signs of toxicity were observed.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the present study, the single dermal application of the test item L-Cysteine to three rabbits at a dose of 0.5 g showed neither irritant nor corrosive effects.
Neither mortalities nor significant clinical signs of toxicity were observed.
The test item L-Cysteine does not have to be classified and has no obligatory labelling requirement for skin irritation. - Executive summary:
L-Cysteine was tested in an Acute dermal Irritation/Corrosion test in rabbits according to OECD Guideline 404.
On the basis of the test results, the substance should be assigned the following risk phrase:no phrase
On the basis of the test results, the substance should be: Not classified
On the basis of the test results, the substance should be: not classified
Species/strain: New Zealand White Rabbits Crl: KBL (NZW)
Number of animals: 3
Duration of exposure: 4h
Amount of substance: 0.5 g per test site
Type of dressing: semi-occlusive
Vehicle (moistening): aqua ad injectionem
First time of effects: no effects observed
Last time of effects: no effects observed
Reversibility of the observed effects: no effects observed
Method: OECD 404 [3]; EC 440/2008, Method B.4 [4]; OPPTS 870.2500 [5]
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