Registration Dossier

Diss Factsheets

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:
2012
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

Constituent 1
Chemical structure
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

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]