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Toxicological information

Skin sensitisation

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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:
1976
Report Date:
1976

Materials and methods

Test guideline
Qualifier:
according to
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
Name:
Unnamed
Type:
Constituent
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

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 group
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 group
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 group
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.