3,7-dimethyloct-6-enenitrile

Skin sensitisation

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other: GLP compliant non-guideline study, available as unpublished report, no restrictions, fully adequate for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: the method that is described by Draize, J.H.

Principles of method if other than guideline:

According to Landsteiner/Draize (J.H. Draize, "Dermal toxicity", Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics (The Association of Food and Drug Officials of the United States, 1975), pp. 51-21. Twelve male Hartley guinea pigs were ten times intradermal exposed (concentration 0.1%) to 3,7-dimethyloct-6-enenitrile over a period of three weeks for induction. After a resting period of 2 weeks, the animals were challenged intradermally with 0.1% of the test substance.

GLP compliance:

yes

Type of study:

Draize test

Justification for non-LLNA method:

Data on skin sensitisation in guinea pigs is aldready available (Givaudan, 1980)

Test material

Test material information

Constituent 1

Reference substance name:

3,7-dimethyloct-6-enenitrile

EC Number:

257-288-8

EC Name:

3,7-dimethyloct-6-enenitrile

Cas Number:

51566-62-2

Molecular formula:

C10H17N

IUPAC Name:

3,7-dimethyloct-6-enenitrile

Details on test material:

- Name of test material: Citronellal Nitril #04526, J79-261.

In vivo test system

Test animals

Species:

guinea pig

Strain:

Hartley

Sex:

male

Details on test animals and environmental conditions:

TEST ANIMALS
- Age at study initiation: 4-6 weeks.
- Weight at study initiation: 294-470 g.
- Housing: galvanized or stainless steel cages.
- Diet: growth and maintenance ration.
- Water: ad libitum.
- Acclimation period: 7 days.

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

intradermal

Vehicle:

physiological saline

Induction 2

Concentration / amount:

0.1%

Challenge

Challenge 1

Route:

intradermal

Vehicle:

physiological saline

Challenge 2

Concentration / amount:

0.1%

No. of animals per dose:

12

Details on study design:

Twelve animals were prepared by close-clipping the mid-dorsal area of the trunk with a small animal clipper equipped with a #40 (surgical) head. The test site was an area 3 or 4 centimeters square located centrally in the clipped region.
Ten intradermal injections, using a 26 gauge hypodermic needle, were made at random in the test area over a period of 3 weeks. Each injection site was scored 24 hours following treatment, for diameter and height in millmeters and color (erythema), using the Draize skin scoring scale.
Two weeks after the last injection, a challenge injection was made, 0.05 mL of a freshly prepared batch of the test suspension. Observations were again recorded 24 hours for the parameters indicated above.
If the readings at the challenge were considerably higher than the average readings for the 10 induction injections, the test article was considered a sensitizer in guinea pigs. The proportional severity of the response determines the degree of sensitization.
Initial and terminal bodyweights were recorded. Animals surviving the full term of the study, as well as non-survivors, were subjected to gross necropsy, with all findings noted.

Challenge controls:

No data.

Positive control substance(s):

not specified

Results and discussion

In vivo (non-LLNA)

Results

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

0.05 mL

No. with + reactions:

0

Total no. in group:

12

Clinical observations:

No erythema or edema seen in any site following challenge.

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.05 mL. No with. + reactions: 0.0. Total no. in groups: 12.0. Clinical observations: No erythema or edema seen in any site following challenge..