Registration Dossier
Registration Dossier
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EC number: 228-985-4 | CAS number: 6386-38-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March 8, 1982 - March 15, 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: non GLP study, limited details but acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Proposed Guidelines of the United States Environmental Agency (EPA) § 163.81-5 "Primary dermal irritation study". Federal Register, Vol. 43, No. 163, August 22, 1978.
- GLP compliance:
- no
Test material
- Reference substance name:
- Methyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate
- EC Number:
- 228-985-4
- EC Name:
- Methyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate
- Cas Number:
- 6386-38-5
- Molecular formula:
- C18H28O3
- IUPAC Name:
- methyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoate
- Details on test material:
- - Physical state: solid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madörin
- Age at study initiation: adults
- Weight at study initiation: 2-3 kg
- Housing: individually in metal cages
- Diet: ad libitum standard rabbit food - NAFAG, No. 814, Gossau SG
- Water: ad libitum
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 50 +/- 10
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- not specified
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mg - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 7 days
- Number of animals:
- 3 males and 3 females
- Details on study design:
- TEST SITE
- Area of exposure: area of 2.5 x 2.5 cm
- Type of wrap if used: Gauze patches covered with an impermeable material and were fastened to the body of the rabbit with adhesive tape.
SCORING SYSTEM: DRAIZE Scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24 and 72 hours
- Score:
- 0.6
- Max. score:
- 8
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Remarks:
- intact skin
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Remarks:
- intact skin
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
Any other information on results incl. tables
Individual Scores:
| animal 1 | animal 2 | animal 3 | animal 4 | animal 5 | animal 6 | |
| erythema score | ||||||
| 24 hours | 1 | 1 | 1 | 1 | 0 | 0 |
| 48 hours | 0 | 1 | 0 | 0 | 0 | 0 |
| 72 hours | 0 | 0 | 0 | 0 | 0 | 0 |
| mean | 0.3 | 0.7 | 0.3 | 0.3 | 0 | 0 |
| mean all animals | 0.3 | |||||
| edema score | ||||||
| 24 hours | 1 | 0 | 0 | 0 | 0 | 0 |
| 48 hours | 1 | 0 | 0 | 0 | 0 | 0 |
| 72 hours | 0 | 0 | 0 | 0 | 0 | 0 |
| mean | 0.7 | 0 | 0 | 0 | 0 | 0 |
| mean all animals | 0.1 | |||||
Primary Irritation Index:
| erythema | edema | ||||
| Time | intact skin | abraded skin | intact skin | abraded skin | |
| 24 | 0.7 | 1 | 0.2 | 0.5 | |
| 72 | 0 | 0 | 0 | 0 | |
| total | 0.7 + 1 + 0.2 + 0.5 = 2.4 | ||||
primary irritation index = 2.4 : 4 = 0.6
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of the present experiment the test substance showed minimal erythema and edema formation, reversible within 72 hours.
- Executive summary:
The test substance (0.5 g) was applied under occlusive conditions to the intact and abraded skin of 6 New Zealand White rabbits. After 24 hours the dressing was removed and the scores were assessed at 24, 48 and 72 hours. Only minimal edema and erythema reactions were observed in both intact and abraded test sited, all reactions reversed to normal after 72 hours. Therefore, the test substance is not considered to be irritating to the rabbit skin.
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