Registration Dossier
Registration Dossier
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EC number: 295-653-3 | CAS number: 92113-48-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- June 6th, 1989 - June 23rd, 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with acceptable restrictions Limited details on test substance
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Limited details on test substance
- GLP compliance:
- yes
Test material
- Reference substance name:
- Fatty acids, C16-18, triesters with trimethylolpropane
- EC Number:
- 293-037-9
- EC Name:
- Fatty acids, C16-18, triesters with trimethylolpropane
- Cas Number:
- 91050-90-7
- IUPAC Name:
- 91050-90-7
- Details on test material:
- - Physical state: Solid, white
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Kleinrusse, Chbb:HM
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Fa. Thomae, Bieberach, Germany
- Weight at study initiation: mean: 2420 g
- Diet: Altromin 2023, ad libitum
- Water: ad libitum
- Acclimatisation: approx. 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 45-70
- Photoperiod (hrs dark / hrs light):12/12
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:
- 72 h
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm²
SCORING SYSTEM: according to 84/449/EWG [Amtsblatt der Europäischen Gemeinschaft L 251/108]
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #1176
- Time point:
- other: 24 h, 48 h and 72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal: #1177
- Time point:
- other: 24 h, 48 h and 72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- erythema score
- Basis:
- animal: #1179
- Time point:
- other: 24 h, 48 h and 72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of all three animals
- Time point:
- other: 24 h, 48 h and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No effects observed
Any other information on results incl. tables
Erythema score
Animal Number |
1 h |
1 day |
2 days |
3 days |
1176 |
0 |
1 |
1 |
0 |
1177 |
0 |
1 |
0 |
0 |
1179 |
0 |
1 |
0 |
0 |
Oedema Score
Animal Number |
1 h |
1 day |
2 days |
3 days |
1176 |
0 |
0 |
0 |
0 |
1177 |
0 |
0 |
0 |
0 |
1179 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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