Registration Dossier
Registration Dossier
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EC number: 291-174-9 | CAS number: 90342-37-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19 February, 1985 to 22 March, 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
Test material
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- None
Constituent 1
- Specific details on test material used for the study:
- Test substance: FAT 45082/D
Batch No.: EN 35713.42
Physical properties: powder; dispersible in water; pH: 8.5 (1 g/L water)
Validity: June 1989
Safety precautions: gloves and face masks
Test material received: February 11, 1985
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: approx. 12-14 weeks old
- Weight at study initiation: 2 to 3 kg
- Housing: The animals were housed individually in metal cages, identified with individually numbered ear tags
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12 hours light cycle day
IN LIFE PHASE- From: 19 February, 1985; To: 26 February, 1985
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48, and 72 hours
- Number of animals:
- 3 male rabbits
- Details on study design:
- TEST SITE
- Area of exposure: at least 6 cm²
- Type of wrap if used: The patches were loosely covered with an aluminum foil (36 cm²)
SCORING SYSTEM:
The irritant / corrosive potency of FAT 45'082/D was classified according to the EEC commission directive No. 83/467/1983
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.78
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.56
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritant / corrosive response data:
- None
- Other effects:
- Body weight gain was normal during the experimental period.
Any other information on results incl. tables
Scoring tables
| Erythema | ||||||
| Animal | 1 hour | 24 hours | 48 hours | 72 hours | 7 days | |
| 69 | 2 | 2 | 2 | 1 | 0 | |
| 70 | 2 | 1 | 1 | 0 | 0 | |
| 71 | 1 | 0 | 0 | 0 | 0 | |
| Total | 5 | 3 | 3 | 1 | ||
| 1.67 | 1.00 | 1.00 | 0.33 | |||
| Edema | ||||||
| Animal | 1 hour | 24 hours | 48 hours | 72 hours | 7 days | |
| 69 | 1 | 2 | 1 | 0 | 0 | |
| 70 | 1 | 1 | 1 | 0 | 0 | |
| 71 | 1 | 0 | 0 | 0 | 0 | |
| Total | 3 | 3 | 2 | 0 | ||
| 1.00 | 1.00 | 0.67 | 0.00 | |||
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 45'082/D can be classified as non irritant according to the EEC directive No. 83/467/1983.
- Executive summary:
The skin irritation potential of FAT 45082/D was evaluated in a study conducted according to OECD Guideline 404. 3 male rabbits were used for this purpose. Under the experimental conditions employed, FAT 45082/D induced erythema and edema reactions when applied to the clipped albino rabbit skin. The mean scores for erythema and edema were 0.78 and 0.56, respectively. Because the mean values of the scores at 24 to 72 hours after application were under the threshold of significance, FAT 45082/D can be classified as non-irritant according to the EEC directive No. 83/467/1983.
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