[1aR-(1aα,4aα,7α,8aS*)]-octahydro-4,4,8,8-tetramethyl-4a,7-methano-4aH-naphth[1,8a-b]oxirene

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

May, 1980

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Study performed equivalent OECD 406 guideline. Non GLP and only a very short description of method. In addition, some relevant method deviations.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Deviations:

yes

Remarks:

no details on test material, no details on animals/environmental conditions, no negative/no positive control group. No irritation data after induction reported, thus not clear whether the animals have been sufficiently induced. No conclusion can be drawn

GLP compliance:

no

Remarks:

not present at the time of performance.

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

Alternative in vivo method

Test material

Test material information

Constituent 1

Reference substance name:

[1aR-(1aα,4aα,7α,8aS*)]-octahydro-4,4,8,8-tetramethyl-4a,7-methano-4aH-naphth[1,8a-b]oxirene

EC Number:

247-851-6

EC Name:

[1aR-(1aα,4aα,7α,8aS*)]-octahydro-4,4,8,8-tetramethyl-4a,7-methano-4aH-naphth[1,8a-b]oxirene

Cas Number:

26619-69-2

Molecular formula:

C15H24O

IUPAC Name:

[1aR-(1aα,4aα,7α,8aS*)]-octahydro-4,4,8,8-tetramethyl-4a,7-methano-4aH-naphth[1,8a-b]oxirene

impurity 1

Reference substance name:

7,7,8,8-tetramethyloctahydro-2,3b-methanocyclopenta[1,3]cyclopropa[1,2]benzen-4-ol

Cas Number:

29461-20-9

Molecular formula:

C15H24O

IUPAC Name:

7,7,8,8-tetramethyloctahydro-2,3b-methanocyclopenta[1,3]cyclopropa[1,2]benzen-4-ol

Test material form:

liquid

Details on test material:

- Name of test material (as cited in the expert statement): Folenox
- Chemical name: 4,4,8,8-Tetramethyloctahydro-4a,7-methanonaphtho[1,8a-b]oxirene (IUPAC)
- Empirical formula: C15H24O
- Structural formula: See IUCLID section 1

In vivo test system

Test animals

Species:

guinea pig

Strain:

not specified

Sex:

not specified

Details on test animals and environmental conditions:

TEST ANIMALS
No data

ENVIRONMENTAL CONDITIONS
No data

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

intradermal and epicutaneous

Vehicle:

petrolatum

Induction 2

Concentration / amount:

Induction:
- intradermal: 5% test substance
- topical (epidermal): 25% test substance in petrolatum
Challenge: 1, 3 and 10% in petrolatum

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

petrolatum

Challenge 2

Concentration / amount:

Induction:
- intradermal: 5% test substance
- topical (epidermal): 25% test substance in petrolatum
Challenge: 1, 3 and 10% in petrolatum

No. of animals per dose:

19 were exposed to the test substance.

Details on study design:

On day 0, the animals were injected intradermally with 0.1 mL of a 5% solution of the test substance, with 0.1 mL of a 5% emulsion of the test substance in Freunds Complete Adjuvant (FCA) and with 0.1 mL of FCA alone, each injection was given twice.
In addition, on day 8 the test substance, dissolved in petrolatum up to 25%, was applied to a clipped skin area of the neck and kept under occlusive bandage for 48 hours. On day 21, an occlusive patch test with the test substance in petrolatum was applied to the flank for 24 hours and the reactions were read 24 and 48 hours after removing of the patch.

Positive control substance(s):

not specified

Results and discussion

In vivo (non-LLNA)

Results

Results 1

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

1, 3 and 10%

No. with + reactions:

0

Total no. in group:

19

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1, 3 and 10%. No with. + reactions: 0.0. Total no. in groups: 19.0.

Results 2

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

1, 3 and 10%

No. with + reactions:

0

Total no. in group:

19

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1, 3 and 10%. No with. + reactions: 0.0. Total no. in groups: 19.0.

Results 3

Reading:

rechallenge

Hours after challenge:

24

Group:

test chemical

Dose level:

1, 3 and 10%

No. with + reactions:

0

Total no. in group:

19

Remarks on result:

other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 1, 3 and 10%. No with. + reactions: 0.0. Total no. in groups: 19.0.

Results 4

Reading:

rechallenge

Hours after challenge:

48

Group:

test chemical

Dose level:

1, 3 and 10%

No. with + reactions:

0

Total no. in group:

19

Remarks on result:

other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 1, 3 and 10%. No with. + reactions: 0.0. Total no. in groups: 19.0.

Any other information on results incl. tables

As no irritation data after induction has been reported, it is not clear whether the animals have been sufficiently induced.

Therefore, this study is considered reliable with restictions.

Applicant's summary and conclusion

Interpretation of results:

other: no conclusion can be drawn

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

In a maximization test with guinea pigs performed equivalent to OECD 406 guideline, Folenox was found not to be a skin sensitiser under the limited conditions of this test.

Executive summary:

A maximization study in guinea pigs with Folenox was performed equivalent to OECD 406 guideline. A concentration of 5% was used for the intradermal induction, 25% for the epidermal induction and 1, 3 and 10% for the challenge. No positive reaction was observed.

Folenox is not considered to be a sensitizer.