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EC number: 263-193-2 | CAS number: 61791-59-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2004-11-09 to 2004-11-30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Glycine, N-methyl-, N-coco acyl derivs., sodium salts
- EC Number:
- 263-193-2
- EC Name:
- Glycine, N-methyl-, N-coco acyl derivs., sodium salts
- Cas Number:
- 61791-59-1
- Molecular formula:
- Not applicable
- IUPAC Name:
- disodium 2-(N-methyldodecanamido)acetate 2-(N-methyltetradecanamido)acetate
- Test material form:
- not specified
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: SPF albino rabbits of the stock Chbb:HM
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: DIMED Schönwalde GmbH, Schönwalde, Germany; Charles River Deutschland GmbH, Kißegg, Germany
- Age at study initiation: 15-24 months
- Weight at study initiation: 2200-3100 g
- Housing: three female rabbits were caged individually in a polyphenyl (PPE) cage
- Diet: pelleted Altromin 2123, Lage, Lippe, ad libitum
- Water: (tap/filtered) water, ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 55±15
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- other: untreated site of the same animal served as control
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- Initial test: 3 min, 1 and 4 h
Confirmatory test: 4 h - Observation period:
- 14 days
Reading time points: 1, 24, 48, 72 h and 7 and 14 days - Number of animals:
- 3 females
- Details on study design:
- TEST SIDE:
- Area of exposure: 6.25 cm² on the left side of the back
- Type of wrap: The treated skin was covered with adhesive Gothaplast tape (2.5 cm)
REMOVAL OF TEST SUBSTANCE:
- Washing: Residual test material was removed with mild soap and lukewarm water.
- Time after start of exposure: 3 min, 1 and 4 h
SCORING SYSTEM:
Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- - Animal #1 used in the initial test showed a well-defined erythema on the posterior left test field immediately after the application.
- 1 h after the termination of exposure a well-defined erythema was observed on the posterior left test field of animal #1. Animal #2 showed a well-defined erythema on the anterior left test field, whereas a very slight erythema was observed on the anterior left test field of animal #3.
- 24, 48 and 72 h after the termination of exposure animal #1 showed a very slight erythema on the posterior left test field. A well-defined erythema and a very slight oedema were observed on the anterior left test field of animal #2. Animal #3 showed no skin reactions.
- 7 days after the termination of exposure small, white scales were still observed on approximately 60% of the anterior left test area of animal #2, whereas animal #1 showed no skin reactions anymore.
- 14 days after the termination of exposure animal #2 was free of any signs of skin irritation, too.
- The mean value for erythema and oedema formation calculated from these individual scores was 1.0 and 0.3 respectively.
Any other information on results incl. tables
Table 1: Summary of erythema and edema scores
Observation time |
Rabbit No. |
|||||
1 |
2 |
3 |
||||
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
|
1 h |
2 |
0 |
2 |
0 |
1 |
0 |
24 h |
1 |
0 |
2 |
1 |
0 |
0 |
48 h |
1 |
0 |
2 |
1 |
0 |
0 |
72 h |
1 |
0 |
2 |
1 |
0 |
0 |
Mean value 24 + 48 + 72 h |
1 |
0 |
2 |
1 |
0 |
0 |
Mean value 24 + 48 + 72 h (all animals) |
1 |
0 |
|
|||
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
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