Registration Dossier
Registration Dossier
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EC number: 203-093-8 | CAS number: 103-26-4
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: pre-guideline study but performed fulfilling basic scientific principles
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- Modified Challenge with intradermal and occlusive application
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Methyl cinnamate
- EC Number:
- 203-093-8
- EC Name:
- Methyl cinnamate
- Cas Number:
- 103-26-4
- Molecular formula:
- C10H10O2
- IUPAC Name:
- methyl 3-phenylacrylate
- Test material form:
- other: solid, applied as solution
- Details on test material:
- no details provided on test material in report
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: water, Freund's Complete Adjuvant (FCA) and petrolatum
- Concentration / amount:
- Induction: 2 intradermal injections of 5% aqueous solution and 2 5%solutions in Freunds' Complete Adjuvant (each 0.1 ml) and 25% in petrolatum on day 8 occlusive for 2 days (total dose 20 mg intradermally plus 250 mg epicutaneously)
Challenge: On day 21 with 25% in petrolatum occlusive for 24 hours.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: water, Freund's Complete Adjuvant (FCA) and petrolatum
- Concentration / amount:
- Induction: 2 intradermal injections of 5% aqueous solution and 2 5%solutions in Freunds' Complete Adjuvant (each 0.1 ml) and 25% in petrolatum on day 8 occlusive for 2 days (total dose 20 mg intradermally plus 250 mg epicutaneously)
Challenge: On day 21 with 25% in petrolatum occlusive for 24 hours.
- No. of animals per dose:
- 5 animals
- Details on study design:
- On day 0, the animals were injected intradermally with 0.1 ml of a 5% solution of the compound, with 0.1 ml of a 5% emulsion of the compound in FCA and with 0.1 ml of FCA alone, each injection was given twice. In addition, on day 8 the compound, dissolved in petrolatum up to 25%, was applied to a clipped skin area of the neck and kept under occlusive bandage for 2 days (total dose 20 mg intraderzzally plus 250 mg epicutaneously).0n day 21, an occlusive patch test with the compound in petrolatum was applied to the flank for 24 hours and the reactions were read 24 and 48 hours after removing the patch.
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other: 1st (24h after challenge) and 2nd (48 after challenge) reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25% solution
- No. with + reactions:
- 3
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: other: 1st (24h after challenge) and 2nd (48 after challenge) reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25% solution. No with. + reactions: 3.0. Total no. in groups: 5.0.
- Reading:
- rechallenge
- Hours after challenge:
- 144
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 4
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 144.0. Group: test group. Dose level: 25%. No with. + reactions: 4.0. Total no. in groups: 5.0.
Any other information on results incl. tables
Authors conclusion: 60% of the animals show positive test reactions 24 h and 48 h after removing the occlusive challenge patch. Furthermore, epicutaneous tests one week later are positive in 4/5 of the guinea pigs.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The treatment with methyl cinnamate causes sensitization in about 60% (first and second reading) and 80% (rechallenge) of the guinea pigs in the Maximization test.
- Executive summary:
In this Maximization test (intradermal induction and occlusive challenge) 4 out of 5 animals showed positive reaction following rechallenge.
Thus, in this test methyl cinnamate is considered a skin sensitizer.
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