Registration Dossier
Registration Dossier
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EC number: 239-816-9 | CAS number: 15721-78-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 19 to 22 December 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Conducted in a similar manner to validated testing guidelines. Study pre-dates GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- see below
- Principles of method if other than guideline:
- Study was conducted on intact skin sites and abraded skin sites on the same animal. Observations were made on both skin sites. Only results from the intact skin sites are used for classification. Deviations are considered not to effect study reliability.
- GLP compliance:
- no
Test material
- Reference substance name:
- Bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine
- EC Number:
- 239-816-9
- EC Name:
- Bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine
- Cas Number:
- 15721-78-5
- Molecular formula:
- C28H43N
- IUPAC Name:
- 4-(2,4,4-trimethylpentan-2-yl)-N-[4-(2,4,4-trimethylpentan-2-yl)phenyl]aniline
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Batch No.: not specified
- Purity: not specified
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- None stated
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 gm
No additional data - Duration of treatment / exposure:
- 24h
- Observation period:
- 72h
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: back
- preparation of test site: clippered areas on the flank of the animal were left intact while others were abraded with a lancet.
- Type of wrap if used: Gauze patches were then placed over the treated areas and an impervious material was wrapped snugly around the trunks of the animals to hold the patches in place.
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 hours
SCORING SYSTEM: Draize method
No additional data
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: mean of 24 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: Intact Skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: mean of 24 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: Abraded Skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: mean of 24 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: Intact Skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: mean of 24 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: Abraded Skin
- Irritant / corrosive response data:
- No information provided
- Other effects:
- No information provided
Any other information on results incl. tables
Primary skin irritation scores
Erythema and Eschar Formation |
Reading (Hours) |
Rabbit Number |
Average |
|||||
1 |
2 |
3 |
4 |
5 |
6 |
|||
Intact Skin |
24 |
0 |
0 |
0 |
0 |
0 |
0 |
0.00 |
Intact Skin |
72 |
0 |
0 |
0 |
0 |
0 |
0 |
0.00 |
Abraded Skin |
24 |
0 |
0 |
0 |
0 |
0 |
0 |
0.00 |
Abraded Skin |
72 |
0 |
0 |
0 |
0 |
0 |
0 |
0.00 |
Subtotal 0.00 |
||||||||
Edema Formation |
Reading (Hours) |
Rabbit Number |
Average |
|||||
1 |
2 |
3 |
4 |
5 |
6 |
|||
Intact Skin |
24 |
0 |
0 |
0 |
0 |
0 |
0 |
0.00 |
Intact Skin |
72 |
0 |
0 |
0 |
0 |
0 |
0 |
0.00 |
Abraded Skin |
24 |
0 |
0 |
0 |
0 |
0 |
0 |
0.00 |
Abraded Skin |
72 |
0 |
0 |
0 |
0 |
0 |
0 |
0.00 |
Subtotal 0.00 |
||||||||
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine would not be classified as a primary irritant to albino rabbits.
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