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EC number: 246-309-6 | CAS number: 24549-06-2
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)
- Rationale for reliability incl. deficiencies:
- other: comparable to guideline study with acceptable restrictions
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
- Reference Type:
- secondary source
- Title:
- ECB(2000) CIBA-GEIGY, Ltd., unpublished data, "Report on Skin Sensitization Effects in Guinea Pigs C 25 702," Basel, Switzerland, 1983.
- Author:
- European Commission - European Chemicals Bureau
- Year:
- 2 000
- Bibliographic source:
- ECB(2000) CIBA-GEIGY, Ltd., unpublished data, "Report on Skin Sensitization Effects in Guinea Pigs C 25 702," Basel, Switzerland, 1983.
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- older version
- Deviations:
- yes
- Remarks:
- earlier version of OECD guideline 406
- GLP compliance:
- yes
- Type of study:
- Maurer optimisation test
Test material
- Reference substance name:
- 6-ethyl-2-toluidine
- EC Number:
- 246-309-6
- EC Name:
- 6-ethyl-2-toluidine
- Cas Number:
- 24549-06-2
- Molecular formula:
- C9H13N1
- IUPAC Name:
- 2-ethyl-6-methylaniline
- Details on test material:
- IUCLID4 Test substance: other TS: 2-methyl-6-ethylaniline, technical, 98% purity, red liquid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright white strain (Tif: DHP)
- Sex:
- male/female
- Details on test animals and environmental conditions:
- Acclimation period: 11 days
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 0.1 % intradermal, epicutaneous: 30 %
Challengeopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- physiological saline
- Concentration / amount:
- 0.1 % intradermal, epicutaneous: 30 %
- No. of animals per dose:
- 10 males, 10 females treatment group, 18 animals control
- Details on study design:
- No. of exposures: induction consisted of atotal of 10 intracutaneous injections given every second day (except weekends)
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other: intradermal challenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 18
- Clinical observations:
- no effects
- Remarks on result:
- other: Reading: other: intradermal challenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 18.0. Clinical observations: no effects.
- Reading:
- other: intradermal challenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1 %
- No. with + reactions:
- 7
- Total no. in group:
- 20
- Clinical observations:
- marginal skin reactions
- Remarks on result:
- other: Reading: other: intradermal challenge. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1 %. No with. + reactions: 7.0. Total no. in groups: 20.0. Clinical observations: marginal skin reactions.
- Reading:
- other: occlusive epicutaneous
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 18
- Clinical observations:
- no effects
- Remarks on result:
- other: Reading: other: occlusive epicutaneous. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 18.0. Clinical observations: no effects.
- Reading:
- other: occlusive epicutaneous
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 18
- Clinical observations:
- no effects
- Remarks on result:
- other: Reading: other: occlusive epicutaneous. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 18.0. Clinical observations: no effects.
- Reading:
- other: occlusive epicutaneous
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 30 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no effects
- Remarks on result:
- other: Reading: other: occlusive epicutaneous. . Hours after challenge: 24.0. Group: test group. Dose level: 30 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no effects.
- Reading:
- other: occlusive epicutaneous
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 30 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no effects
- Remarks on result:
- other: Reading: other: occlusive epicutaneous. . Hours after challenge: 48.0. Group: test group. Dose level: 30 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no effects.
- Reading:
- other: rechallenge intradermal
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1 %
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Clinical observations:
- no data
- Remarks on result:
- other: Reading: other: rechallenge intradermal. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1 %. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: no data.
Any other information on results incl. tables
RS-Freetext:
--Two animals died during performance of the test: Deaths
were attributed to lung infections.
--At the first intradermal injection challenge, 7/20 test article induced
animals had positive scores. No control animal (out of 18) had a positive score.
--At the epidermal challenge, no treated animal had a
positive score at the 24 or 48 hour readings.
After the end of the standard test, a second intradermal challenge was conducted: Only 1/20 animals had a positive score. This was not statistically significantly
different from the control group.
It was concluded that the first challenge induction
results were nonspecific reactions, and that the test
article had no sensitizing potential.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Executive summary:
An early Maurer Optimization test revealed no evidence of a skin sensitization potential (Ciba-Geigy 1983).
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