Registration Dossier
Registration Dossier
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EC number: 402-860-6 | CAS number: 110553-27-0 CG 25-1320; IRGANOX 1520; TK 12229/1
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- not specified
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data provided by ECHA - information from migrated NONS file as per inquiry 06-0000021296-70-0000.
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 1 988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Maxlmlzallon Test of Magnusson and Kligman
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- 4,6-bis(octylthiomethyl)-o-cresol
- EC Number:
- 402-860-6
- EC Name:
- 4,6-bis(octylthiomethyl)-o-cresol
- Cas Number:
- 110553-27-0
- Molecular formula:
- C25H44OS2
- IUPAC Name:
- 4,6-bis(octylthiomethyl)-o-cresol
Constituent 1
In vivo test system
Test animals
- Species:
- other: Albino guinea pig
Study design: in vivo (non-LLNA)
Induction
- Concentration / amount:
- Concentration of the test material and vehicle used at induction:
1st induction (intradermal): 1% in sesame oil and adjuvant saline mixture
2nd induction (epidermal): 30% in vaseline
Concentration of the test material used for each challenge:
3% in vaseline
Challenge
- Concentration / amount:
- Concentration of the test material and vehicle used at induction:
1st induction (intradermal): 1% in sesame oil and adjuvant saline mixture
2nd induction (epidermal): 30% in vaseline
Concentration of the test material used for each challenge:
3% in vaseline
- No. of animals per dose:
- Number of animals In test group: 20
Number of animals In negative control group: 20
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 3%
- No. with + reactions:
- 7
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 3%. No with. + reactions: 7.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 3%
- No. with + reactions:
- 6
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 3%. No with. + reactions: 6.0. Total no. in groups: 20.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 3%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 3%. No with. + reactions: 1.0. Total no. in groups: 20.0.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 3%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 3%. No with. + reactions: 1.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 3%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 3%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 3%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 3%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Any other information on results incl. tables
Maximum concentrati~n not causing irritating effects in preliminary test: 3 %
Signs of irritation during induction:
10% in vaseline induced erythema reactions.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance is not sensitizing to the skin of guinea pigs.
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