Registration Dossier
Registration Dossier
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EC number: 239-816-9 | CAS number: 15721-78-5
Endpoint summary
Administrative data
Description of key information
Skin irritation:
0/6 animals showed signs of skin irriation to Bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine would (Biosearch, 1979).
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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.
- 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
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- None stated
- 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 - 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
- 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.
Reference
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 |
||||||||
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 19 to 26 December 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Limited study summary, conducted in a similar manner to validated testing guidelines. Study pre-dates GLP.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- TEAT ANIMALS
- Age at study initiation: young adult
No additional data. - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 g
No additional data. - Duration of treatment / exposure:
- 7 days
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: The test material was not washed from the eyes.
SCORING SYSTEM: Draize Scale of Scoring Ocular Lesions.
No additional data. - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: Mean of 24, 48 & 72 hrs
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: Mean of 24, 48 & 72 hrs
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: Mean of 24, 48 & 72 hrs
- Score:
- ca. 0.06
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: Mean of 24, 48 & 72 hrs
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 h
- Irritant / corrosive response data:
- No information provided.
- Other effects:
- No information provided.
- 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 is not a primary ocular irritant.
Reference
Grades for Ocular Lesions
|
Rabbit No |
Cornea |
Iris |
Conjunctivae |
|||
opacity |
Area |
Redness |
Chemosis |
Discharge |
|||
1 hour |
1 |
0 |
0 |
0 |
1 |
1 |
1 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3 |
0 |
0 |
0 |
1 |
1 |
2 |
|
4 |
0 |
0 |
0 |
1 |
1 |
1 |
|
5 |
0 |
0 |
0 |
1 |
0 |
1 |
|
6 |
0 |
0 |
0 |
0 |
0 |
1 |
|
24 hours |
1 |
0 |
0 |
0 |
1 |
0 |
1 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3 |
0 |
0 |
0 |
0 |
0 |
0 |
|
4 |
0 |
0 |
0 |
0 |
0 |
0 |
|
5 |
0 |
0 |
0 |
0 |
0 |
1 |
|
6 |
0 |
0 |
0 |
0 |
0 |
0 |
|
48 hours |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3 |
0 |
0 |
0 |
0 |
0 |
0 |
|
4 |
0 |
0 |
0 |
0 |
0 |
0 |
|
5 |
0 |
0 |
0 |
0 |
0 |
0 |
|
6 |
0 |
0 |
0 |
0 |
0 |
0 |
|
72 hours |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3 |
0 |
0 |
0 |
0 |
0 |
0 |
|
4 |
0 |
0 |
0 |
0 |
0 |
0 |
|
5 |
0 |
0 |
0 |
0 |
0 |
0 |
|
6 |
0 |
0 |
0 |
0 |
0 |
0 |
|
5 days |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3 |
0 |
0 |
0 |
0 |
0 |
0 |
|
4 |
0 |
0 |
0 |
0 |
0 |
0 |
|
5 |
0 |
0 |
0 |
0 |
0 |
0 |
|
6 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7 days |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3 |
0 |
0 |
0 |
0 |
0 |
0 |
|
4 |
0 |
0 |
0 |
0 |
0 |
0 |
|
5 |
0 |
0 |
0 |
0 |
0 |
0 |
|
6 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Dermal Irritation:
In a study conducted similar or equivalent to OECD 404 (pre-dates GLP), bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine failed to induce any dermal irritation in rabbits over a 72 hour exposure period. 2 test sites on each of 6 rabbits were used as well as an additional control site. 1 test site was abraded, and 1 test site remained intact. Neither test site produced any irritation response. This deviation from the study guideline was considered not to affect the reliability of the study and it's result (Biosearch, 1979).
Eye Irritation:
In a study conducted similar or equivalent to OECD 405 (pre-dates GLP), bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine failed to induce any eye irritation in 6 rabbits (Biosearch, 1979).
Justification for selection of skin irritation / corrosion endpoint:
Key study, equivalent or similar to OECD Guideline 404. Minor deviations were noted in the study report (2 test sites were used, 1 test site was abraded and 1 left intact). These deviations were considered not to affect the reliability of the study. Study pre-dates GLP.
Justification for selection of eye irritation endpoint:
Key study, equivalent or similar to OECD Guideline 405. Study pre-dates GLP.
Justification for classification or non-classification
Dermal irritation:
Bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine failed to induce any dermal irritation in 6 rabbits over a 72 hour exposure period. In accordance with EC Regulation 1272/2008, bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine does not meet the requirements for classification as a dermal irritant or corrosive to skin.
Eye irritation:
Bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine failed to induce any eye irritation in 6 rabbits. In accordance with EC Regulation 1272/2008, bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine does not meet the requirements for classification as an eye irritant or corrosive to the eye.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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