Registration Dossier
Registration Dossier
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EC number: 203-990-4 | CAS number: 112-61-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1992-04-07 to 1992-04-17
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- analytical purity of test material not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- Methyl stearate
- EC Number:
- 203-990-4
- EC Name:
- Methyl stearate
- Cas Number:
- 112-61-8
- Molecular formula:
- C19H38O2
- IUPAC Name:
- methyl octadecanoate
- Details on test material:
- - Name of test material (as cited in study report): Stearinsäuremethylester
- Substance type: Stearic acid methyl ester
- Physical state: solid, white
- Analytical purity: Not indicated
- Storage condition of test material: RT, protected from light
- Impurities (identity and concentrations): not specified
- Expiration date: 17.09.1992
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Kleinrussen, Chbb:HM
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Thomae, Germany
- Age at study initiation: approx 14 months
- Weight at study initiation: approx. 2320 g
- Diet: ad libitum (Ssniff rabbit diet K 4)
- Water: ad libitum
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 45-70
- Photoperiod (hrs dark / hrs light): 12/12 h
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g - Duration of treatment / exposure:
- 4 h
- Observation period:
- 1h, 24h, 48h, 72h, 7d, 14d and 21 d
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: dorsal skin, 6 cm²
- Type of wrap if used: air- and vapour permeable moisted gauze-patch fixed with hypoallergenic adhesive gauze-bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes. After exposure the skin was cleaned from the residual test substance.
SCORING SYSTEM: According to the council directive 84/449/EEC (Draize)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 1319
- Time point:
- other: average 24, 48 and 72h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 d
- Remarks on result:
- other: Eschar formation observed at day 7
- Irritation parameter:
- erythema score
- Basis:
- animal: 1320
- Time point:
- other: average 24, 48 and 72h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 d
- Remarks on result:
- other: Eschar formation observed at day 7
- Irritation parameter:
- erythema score
- Basis:
- animal: 1321
- Time point:
- other: average 24, 48 and 72h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 d
- Remarks on result:
- other: Eschar formation observed at day 7
- Irritation parameter:
- edema score
- Basis:
- animal: 1319
- Time point:
- other: average 24, 48 and 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- edema score
- Basis:
- animal: 1320
- Time point:
- other: average 24, 48 and 72h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 d
- Irritation parameter:
- edema score
- Basis:
- animal: 1321
- Time point:
- other: average 24, 48 and 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
Any other information on results incl. tables
Erythema score
Animal Number |
1 h |
1 day |
2 days |
3 days |
7 days |
14 days |
21 days |
1305 |
1 |
1 |
1 |
1 |
+ S |
+ |
1 |
1322 |
2 |
2 |
2 |
3 |
+ b S |
+ |
0 |
1324 |
1 |
1 |
1 |
1 |
+ S |
+ |
0 |
Edema Score
Animal Number |
1 h |
1 day |
2 days |
3 days |
7 days |
14 days |
21 days |
1305 |
0 |
0 |
0 |
0 |
+ S |
+ |
0 |
1322 |
1 |
2 |
2b |
2 b |
+ b S |
+ |
0 |
1324 |
0 |
0 |
0 |
0 |
+ S |
+ |
0 |
+ = irreversible
S = Eschar
b = brownish discolouration
The test substance caused moderate irritation to all animals that persisted as slight erythema in one animal after the observation time of 21 days. According to DSD and CLP no classification for skin irritation is required.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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