Registration Dossier
Registration Dossier
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Oligomer of 4,4-bis(1,1,3,3-tetramethylbutyl)diphenylamine with N-(4-(2,4,4-trimethylpentan-2-yl)phenyl)naphthalen-1-amineor (according to REACH Guidance on substance identification)Reaction mass of N,N,N'-tri(4-(1,1,3,3-tetramethyl-butyl)phenyl-N'-(di(4-(1,1,3,3-tetramethylbutyl)phenyl)amino)-naphthylhydrazine, N,N,N'-tri(4-(1,1,3,3-tetramethyl-butyl)phenyl-N'-(bis-(di(4-(1,1,3,3-tetramethylbutyl)phenyl)amino))-naphthylhydrazine, N,N,N'-tri(4-(1,1,3,3-tetramethyl-butyl)phenyl-N'-(bis(N''-(4-(1,1,3,3-tetramethylbutyl)phenyl)amino)-N''-naphthyl)naphthylhydrazine, N,N,N'-tri(4-(1,1,3,3-tetramethyl-butyl)phenyl-N'-[x-(di-(4-(1,1,3,3-tetramethylbutyl)phenyl)amino-(4-(1,1,3,3-tetramethylbutyl)phenyl)-amino)naphthylamino)naphthyl-hydrazine, tetrakis 4-(1,1,3,3-tetra-Methyl-butyl)phenylhydrazine and N,N,N'-tris(4-(1,1,3,3-tetramethyl-butyl)phenyl-N'-naphthylhydrazine
EC number: 415-860-6 | CAS number: 68938-84-1
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V (Buehler)
- GLP compliance:
- yes
- Type of study:
- Buehler test
Test material
- Reference substance name:
- -
- EC Number:
- 415-860-6
- EC Name:
- -
- Cas Number:
- 68938-84-1
- IUPAC Name:
- 1-(naphthalen-1-yl)-2,2-bis(4-octylphenyl)-1-[4-(2,4,4-trimethylpentan-2-yl)phenyl]hydrazine; 1-N-[2-({2-[bis(4-octylphenyl)amino]-4-octylphenyl}(4-octylphenyl)amino)-4-octylphenyl]-1-N-(4-octylphenyl)-4-N-[4-(2,4,4-trimethylpentan-2-yl)phenyl]naphthalene-1,4-diamine; 1-N-{2-[bis(4-octylphenyl)amino]-4-octylphenyl}-1-N-(4-octylphenyl)-4-N-[4-(2,4,4-trimethylpentan-2-yl)phenyl]naphthalene-1,4-diamine; 4-octyl-N-(4-octylphenyl)aniline; 5-[2,2-bis(4-octylphenyl)-1-[4-(2,4,4-trimethylpentan-2-yl)phenyl]hydrazin-1-yl]-1-N,1-N,3-N,3-N-tetrakis(4-octylphenyl)naphthalene-1,3-diamine; 5-[2,2-bis(4-octylphenyl)-1-[4-(2,4,4-trimethylpentan-2-yl)phenyl]hydrazin-1-yl]-N,N-bis(4-octylphenyl)naphthalen-2-amine; 5-octyl-1-N,1-N,2-N-tris(4-octylphenyl)benzene-1,2-diamine; tetrakis(4-octylphenyl)hydrazine
Constituent 1
In vivo test system
Test animals
- Species:
- other: Guinea pig (Hartley albino)
Study design: in vivo (non-LLNA)
Induction
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
Topical:
100%, substance moistened with water
Concentration of test material and vehicle used for each challenge:
100%, substance moistened with water
Challenge
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
Topical:
100%, substance moistened with water
Concentration of test material and vehicle used for each challenge:
100%, substance moistened with water
- No. of animals per dose:
- Number of animals in test group: 20
Number of animals in negative control group: 10
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 8
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 8.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 100%. No with. + reactions: 5.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Any other information on results incl. tables
Maximum concentration not causing irritating effects in prelim
Signs of irritating during induction:
Very slight erythema was noted in 8 out of the 20 guinea pigs
Evidence of sensitisation of each challenge concentration:
None
Other observations:
Slight erythema in 7 animals and well defined erythema in 1 animal was observed within 24 hours of the first challenge of the treated group. In the control group, 5 out of 10 animals showed slight erythema.
Yellow staining from the test substance was observed in some animals. This was not considered to have masked any skin reactions.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
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