Registration Dossier
Registration Dossier
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EC number: 231-335-2 | CAS number: 7493-74-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Nov 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Poor description of the test substance (no purity)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1981
- Deviations:
- yes
- Remarks:
- Poor description of the test substance (no purity).
- GLP compliance:
- yes
Test material
- Reference substance name:
- Allyl phenoxyacetate
- EC Number:
- 231-335-2
- EC Name:
- Allyl phenoxyacetate
- Cas Number:
- 7493-74-5
- Molecular formula:
- C11H12O3
- IUPAC Name:
- allyl phenoxyacetate
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 10 - 12 weeks
- Weight at study initiation: approx. 2 kg
- Housing: individually in grid bottomed metal cages
- Diet: SQC standard rabbit pellets (Special Diets Services, Witham, UK), ad libitum
- Water: mains drinking water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 5 - 24 (The system was set to maintain temperature within the range of 17 - 23 °C but the heating equipment failed during the acclimatisation period. Temperature was typically greater than 14 °C during the study period.)
- Humidity (%): 37 - 68
- Air changes (per hr): 6
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin areas
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 mL - Duration of treatment / exposure:
- 4 h
- Observation period:
- 7 days
Reading time points: 1, 24, 48 and 72 h and 7 days - Number of animals:
- 4
- Details on study design:
- TEST SITE
- Area of exposure: dorsal surface of the trunk
- Type of wrap: The test substance was placed over a 2.5 cm square of surgical lint. The lint square was placed either on the left or on the right flank. The lint patch was held in place by encircling the trunk with a length of adhesive bandage (Elastoplast) 10 cm wide.
REMOVAL OF TEST SUBSTANCE
- Washing: The skin was cleaned of residual test substance by gentle swabbing with cotton wool soaked in warm water.
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize scoring system; Reaction to treatment considered to fall mid-way between the points described was scored as a fraction (i.e. 0.5, 1.5, 2.5, etc).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- #1 and #3
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0.17
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- #2 and #3
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- #1 and #4
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0.17
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
Any other information on results incl. tables
Table 1. Results of the irritation study.
Observation time |
Rabbit no. |
|||||||
1 |
2 |
3 |
4 |
|||||
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
|
1 h |
0 |
0 |
0.5 |
0.5 |
0.5 |
0 |
0 |
0 |
24 h |
0.5 |
0.5 |
0.5 |
0 |
0.5 |
0 |
0.5 |
0.5 |
48 h |
0 |
0 |
0.5 |
0 |
0 |
0 |
0.5 |
0 |
72 h |
0 |
0 |
0.5 |
0 |
0 |
0 |
0 |
0 |
7 days |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Mean value 24 + 48 + 72 h |
0.17 |
0.17 |
0.5 |
0.0 |
0.17 |
0 |
0.33 |
0.17 |
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
- Conclusions:
- Under the conditions of this skin irritation study in rabbits the test substance was not irritating to the skin.
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