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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: non GLP, short study report with inconsistencies

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
Guinea Pig Maximisation Test
GLP compliance:
no
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Chemical structure
Reference substance name:
Isopulegol
EC Number:
201-940-6
EC Name:
Isopulegol
Cas Number:
89-79-2
Molecular formula:
C10H18O
IUPAC Name:
isopulegol
Details on test material:
Test Item: Isopulegol
no further data

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 309-416 g
- Age at study initiation: 6 months

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: propyleneglycol plus acetone (1:1)
Concentration / amount:
Intradermal induction: 10%
Epicutaneous induction: 10%
Epicutaneous challenge: 40, 20, 10, 5%
Challengeopen allclose all
Route:
other: epicutaneous (unspecified)
Vehicle:
other: propyleneglycol plus acetone (1:1)
Concentration / amount:
Intradermal induction: 10%
Epicutaneous induction: 10%
Epicutaneous challenge: 40, 20, 10, 5%
No. of animals per dose:
5
Details on study design:
RANGE FINDING TESTS: sighting tests were performed for test substance concentration selection. No further data


MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: no data
- Test groups: intradermal (10% in Complete Adjuvant + 10% in a mixture of Freund´s Complete Adjuvant and phys. saline (1:1)) topical (10% in Complete Adjuvant)
- Control group: yes, no further data on treatment
- Site: back


B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: no data
- Exposure period: 24h
- Test groups: 40, 20, 10, 5% in propyleneglycol/acetone
- Control group: yes, no further data on treatment
- Site: back
- Evaluation (hr after challenge): 24h

OTHER:
Hair was cut with an electric hair clipper and electric shaver
Scoring of dermal reactions acc. to Draize
Challenge controls:
yes
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
40%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 40%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
40%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 40%. No with. + reactions: 0.0. Total no. in groups: 5.0.

Any other information on results incl. tables

The test item produced a sensitisation index of 0 (0/5) in all concentrations tested up to 40% and was classified as a non-sensitiser to guinea pig skin at a maximum concentration of 40%. Accordingly , no reactions were noted at the challenge site of control group animals.

In the test report, the sensitization rate has been described as 0% (0/10), however only 5 animals have been tested per dose group.

Applicant's summary and conclusion