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EC number: 203-212-3 | CAS number: 104-54-1
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:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Justification for type of information:
- Data is from experimental study report
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:
- other: Freund's Complete Adjuvant [FCAT] test
- Principles of method if other than guideline:
- Capacity for allergic sensitization determined by the intradermal test With Freund's Complete Adjuvant [FCAT] test on Guinea pigs.
- GLP compliance:
- not specified
- Type of study:
- Freund's complete adjuvant test
- Justification for non-LLNA method:
- not specified
Test material
- Reference substance name:
- Cinnamyl alcohol
- EC Number:
- 203-212-3
- EC Name:
- Cinnamyl alcohol
- Cas Number:
- 104-54-1
- Molecular formula:
- C9H10O
- IUPAC Name:
- 3-phenylpropan-1-ol
- Test material form:
- other: liquid/ crystalline mass
- Details on test material:
- - Name of test material: 2-Propen-1-ol, 3-phenyl-;cinnamyl alcohol;
- Molecular formula: C9H10O
- Molecular weight: 134.177g/mole
- Smiles : c1(ccccc1)/C=C/CO
- Inchl: 1/C9H10O/c10-8-4-7-9-5-2-1-3-6-9/h1-7,10H,8H2/b7-4-
- Substance type: Organic
- Physical state: liquid/ crystalline mass
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- No data available
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: 0.05 ml of FCA
- Adequacy of induction:
- not specified
- Route:
- intradermal
- Vehicle:
- other: 50% FCA
- Concentration / amount:
- 0.05 ml of the compound (undiluted, diluted or suspended) (total dose approx. 250 mg)
- Day(s)/duration:
- 0, 2, 4, 7 and 9 days
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- epicutaneous, open
- Vehicle:
- other: 0.05 ml of FCA
- Concentration / amount:
- tests were performed by applying 0.025 ml of each test concentration.
- Day(s)/duration:
- 21 and 35 days
- Adequacy of challenge:
- other: primary non irritant solution
- No. of animals per dose:
- 7 animals
- Details on study design:
- RANGE FINDING TESTS:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 5 intradermal injections
- Exposure period: 0, 2, 4, 7 and 9 days
- Test groups: 7 guinea pigs
- Control group: Yes
- Site: Neck
- Frequency of applications: No data available
- Duration: No data available
- Concentrations: 0.025 ml
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 21 and 35
- Exposure period: No data available
- Test groups: 7 guinea pigs
- Control group: Yes
- Site: Neck (Skin area measuring 2 cm2)
- Concentrations: 0.025 ml
- Evaluation (hr after challenge): 24, 48 and 72 hours
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- other: Challenge
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 10% solution
- No. with + reactions:
- 7
- Total no. in group:
- 7
- Clinical observations:
- signs of dermal reactions observed
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- other: Challenge
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 3% solution
- No. with + reactions:
- 4
- Total no. in group:
- 7
- Clinical observations:
- signs of dermal reactions observed
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- other: Challenge
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 1% solution
- No. with + reactions:
- 2
- Total no. in group:
- 7
- Clinical observations:
- signs of dermal reactions observed
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
Induction |
Challenge |
Sensatization rate Testing concentration |
|
3% Pos./total |
1% Pos./total |
||
5 intradermal injections of a 0.1 ml of a 50% emulsion in FREUND’S COMPLETE ADJUVANTS |
Epicutaneously with primary non irritant solution |
4/7 |
2/7 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- Challenging epicutaneous tests with non toxic alcoholic solutions of test chemical, 3 and 5 weeks after the first intradermal injection were positive in 7 out 7 animals with the 10% solution, (the highest non irritant concentration), in 4 out of 7 animals with the 3% solution and in 2 out of 7 animals with the 1% solution.
Therefore,the test chemical was considered to be one of the moderate to strong intradermal sensitizers for the guinea pig in the FCAT and hence classified as skin sensitiser in category 1 as per CLP classification criteria. - Executive summary:
Capacity for allergic sensitization of the test chemical was determined by the intradermal test With Freund's Complete Adjuvant (Fact) on Guinea pigs.
0.05 ml of the compound (undiluted, diluted or suspended) was mixed with the same volume of FCA were injected intradermally into the neck on days 0,2,4,7 and 9 (total dose approx.250 mg).The experimental animals and controls, treated with 0.05 ml of FCA only, were tested epicutaneously on days 21 and 35.These tests were performed by applying 0.025 ml of each test concentration to skin areas measuring 2 cm2. The reactions were read after 24, 48, and 72 hours.
Challenging epicutaneous tests with non toxic alcoholic solutions of test chemical, 3 and 5 weeks after the first intradermal injection were positive in 7 out 7 animals with the 10% solution, (the highest non irritant concentration), in 4 out of 7 animals with the 3% solution and in 2 out of 7 animals with the 1% solution.
Therefore,the test chemical was considered to be one of the moderate to strong intradermal sensitizers for the guinea pig in the FCAT and hence classified as skin sensitiser in category 1 as per CLP classification criteria.
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