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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:
weight of evidence
Study period:
1985
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study conducted similarly to an old version of the OECD test guideline No. 406 (1981) with deviations: concentrations not specified, individual animals weights at beginning and end of the test not reported; grading system not described; individual animal data not reported

Data source

Reference
Reference Type:
publication
Title:
The Freund's Complete Adjuvant Test and the Open Epicutaneous Test. A complementary test procedure for realistic assessment of allergenic potential
Author:
Klecak G
Year:
1985
Bibliographic source:
Curr Probl Dermatol. 14: 152-171

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
adopted in 1981
Deviations:
yes
Remarks:
individual animals weights at beginning and end of the test not reported; grading system not described; no data on individual animal
Principles of method if other than guideline:
Not applicable
GLP compliance:
not specified
Type of study:
open epicutaneous test
Justification for non-LLNA method:
At the time of study completion (1985), the LLNA OECD test method was not adopted.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): γ-Undecalactone

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 300-450 g

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, open
Vehicle:
other: suitable vehicle
Concentration / amount:
minimal irritating concentration, maximal non-irritant concentration and 2 lower non-irritating concentrations
Challenge
Route:
epicutaneous, open
Vehicle:
other: suitable vehicle
Concentration / amount:
minimal irritating concentration, maximal non-irritant concentration and 2 lower non-irritating concentrations
No. of animals per dose:
10 in control and at least 6 per dose in treatment group
Details on study design:
RANGE FINDING TESTS:
- One day before the induction procedure, 6-8 guinea pigs, subsequently used for the experimental group, were applied with test material (0.025 mL) at different concentrations (e.g. 1, 3, 10, 30 and 100 % depending on the solubility) and observed for erythema and oedema at 24 h. This pre-testing phase allows establishing the minimal irritating and the maximal nonirritating concentration i.e. the lowest concentration causing skin irritation and the highest concentration not causing macroscopic skin reactions, respectively.

MAIN STUDY
A. INDUCTION EXPOSURE: Epicutaneous, open
- On Day 1, 0.1 mL of the test material was applied on clipped flank skin (8 cm²) of guinea pigs. The applications were repeated daily for 3 weeks or 5 times weekly during 4 weeks. The application sites were evaluated 24 h after application or at the end of each week.

B. CHALLENGE EXPOSURE: TOPICAL
- All guinea pigs of control and treatment groups were tested on Days 21 and 35 on the contralateral flanks (2 cm²) with the test material (0.025 mL) at the minimal irritating and some lower non-irritating concentrations. The application sites were evaluated 24, 48 and 72 h after application.
Challenge controls:
- During challenge phase, all guinea pigs of control group were tested similarly to treatment group.
Positive control substance(s):
no

Results and discussion

Positive control results:
Not applicable

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
maximum non-irritating concentration
No. with + reactions:
0
Total no. in group:
6
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: maximum non-irritating concentration. No with. + reactions: 0.0. Total no. in groups: 6.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
maximum non-irritating concentration
No. with + reactions:
0
Total no. in group:
6
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: maximum non-irritating concentration. No with. + reactions: 0.0. Total no. in groups: 6.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Group:
positive control
Remarks on result:
not measured/tested

Any other information on results incl. tables

γ-Undecalactone was reported to be negative in the Open Epicutaneous Test (OET).

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under these test conditions, γ-Undecalactone was reported to be negative in the Open Epicutaneous Test (OET) therefore it is not classified according to the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
Executive summary:

An Open Epicutaneous Test (OET) was performed similarly to an old version of the OECD test guideline No. 406 (1981). One day before the induction procedure, 6-8 guinea pigs were applied with γ-Undecalactone (0.025 mL) at different concentrations (e.g. 1, 3, 10, 30 and 100 % depending on the solubility) and observed for erythema and oedema at 24 h. On Day 1, 0.1 mL of γ-Undecalactone was applied on the clipped flank skin (8 cm²) of at least 6 guinea pigs. The applications were repeated daily for 3 weeks or 5 times weekly during 4 weeks. The application sites were evaluated 24 h after application or at the end of each week. Negative or vehicle control was also included in the study. During challenge phase, all guinea pigs of control and treatment groups were tested on Days 21 and 35 on the contralateral flanks (2 cm²) with the test material (0.025 mL) at the minimal irritating and some lower non-irritating concentrations. The application sites were evaluated 24, 48 and 72 h after application.

Under these test conditions, γ-Undecalactone showed negative results in the Open Epicutaneous Test (OET) therefore it is not classified according to the Regulation (EC) No. 1272 /2008 (CLP) and to the GHS.