Registration Dossier
Registration Dossier
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EC number: 610-840-5 | CAS number: 52449-76-0
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to EU / OECD guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- methyl 4-cyano-2-nitrobenzoate
- EC Number:
- 610-840-5
- Cas Number:
- 52449-76-0
- Molecular formula:
- C9H6N2O4
- IUPAC Name:
- methyl 4-cyano-2-nitrobenzoate
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- 15 (10 test and 5 control) female albino Dunkin Hartley guinea pigs
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- Intradermal induction: 15 %
Epidermal Induction: 50 %
Epidermal Challenge: 50%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- Intradermal induction: 15 %
Epidermal Induction: 50 %
Epidermal Challenge: 50%
- No. of animals per dose:
- 10 animals
- Positive control substance(s):
- yes
- Remarks:
- ALPHA-HEXYLCINNAMALDEHYDE
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50% in PEG 300
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- discrete or patchy erythema ; moderate and confluent erythema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50% in PEG 300. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: discrete or patchy erythema ; moderate and confluent erythema.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50% in PEG 300
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- discrete or patchy erythema; moderate and confluent erythema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50% in PEG 300. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: discrete or patchy erythema; moderate and confluent erythema.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 4.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 4.0.
Any other information on results incl. tables
One animal of the control group was found dead on test day 24 (i.e. two days after the challenge application). At necropsy, dense parenchymal focus/foci was noted in the lungs (not collapsed). The cause of death could not be established. The death was considered to be spontaneous and treatment unrelated.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the above mentioned findings the test substance may cause sensitization by skin contact.
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