Nonyl acetate

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study meets generally accepted scientific principles, acceptable for assessment with restrictions: non-GLP study; no data about the purity and no certificate of analysis of the test substance; no information on the strain, age, sex, body weight, source and housing conditions of the animals; individual animal data was not reported.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

Freund's complete adjuvant test

GLP compliance:

no

Remarks:

pre-GLP

Type of study:

Freund's complete adjuvant test

Test material

Test material information

Constituent 1

Reference substance name:

Nonyl acetate

EC Number:

205-585-8

EC Name:

Nonyl acetate

Cas Number:

143-13-5

Molecular formula:

C11H22O2

IUPAC Name:

nonyl acetate

Test material form:

not specified

Details on test material:

- Name of test material (as cited in study report): ACETATE DE NONYLE (n-nonyl acetate)

In vivo test system

Test animals

Species:

guinea pig

Strain:

not specified

Sex:

not specified

Details on test animals and environmental conditions:

None

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

intradermal

Vehicle:

no data

Induction 2

Concentration / amount:

Induction: 5 % emulsion in Freund’s Complete Adjuvant (FCA)
Challenge: Non-irritant solutions (10 % or lower)

Challenge

Challenge 1

Route:

epicutaneous, open

Vehicle:

no data

Challenge 2

Concentration / amount:

Induction: 5 % emulsion in Freund’s Complete Adjuvant (FCA)
Challenge: Non-irritant solutions (10 % or lower)

No. of animals per dose:

10

Details on study design:

MAIN STUDY
A. INDUCTION EXPOSURE: INTRADERMAL
- No. of exposures: 5
- Test groups: 0.1 mL of a 5 % emulsion of the test item in FCA was intradermally injected into the neck of guinea pigs. The emulsion was prepared by mixing 0.05 mL of the test item with 0.05 mL of FCA.
- Control groups: Animals in the control group were treated with 0.05 mL of FCA only.
- Site: Neck
- Frequency of applications: On Days 0, 2, 4, 7 and 9

B. CHALLENGE EXPOSURE: EPICUTANEOUS
- No. of exposures: Two
- Day of challenge: Days 21 and 35
- Test groups: 0.025 mL of the non-irritant solutions of the test item was applied to the skin of the animals.
- Site: Skin (2 cm2)
- Evaluation (h after application): 24, 48 and 72 h

Challenge controls:

Animals in the control group were induced with 0.05 mL of FCA only. During challenge phase, 0.025 mL of the non-irritant solutions of the test item was applied to the skin of these animals.

Positive control substance(s):

no

Results and discussion

Positive control results:

Not applicable

In vivo (non-LLNA)

Results

Results 1

Reading:

other: challenge 1 on Day 21 (readings at 24, 48 and 72 h)

Hours after challenge:

72

Group:

test chemical

Dose level:

Induction: 5 % emulsion in FCA; challenge: non-irritant solutions

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

no data

Remarks on result:

other: see Remark

Remarks:

Reading: other: challenge 1 on Day 21 (readings at 24, 48 and 72 h). . Hours after challenge: 72.0. Group: test group. Dose level: Induction: 5 % emulsion in FCA; challenge: non-irritant solutions. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no data.

Results 2

Reading:

other: challenge 2 on Day 35 (readings at 24, 48 and 72 h)

Hours after challenge:

72

Group:

test chemical

Dose level:

Induction: 5 % emulsion in FCA; challenge: non-irritant solutions

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

no data

Remarks on result:

other: see Remark

Remarks:

Reading: other: challenge 2 on Day 35 (readings at 24, 48 and 72 h). . Hours after challenge: 72.0. Group: test group. Dose level: Induction: 5 % emulsion in FCA; challenge: non-irritant solutions. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no data.

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under these test conditions, ACETATE DE NONYLE was considered not to be a skin sensitiser to guinea pig.

Executive summary:

In a Freund's complete adjuvant test, 0.1 mL of a 5 % emulsion of the test item, ACETATE DE NONYLE, in Freund’s Complete Adjuvant (FCA) was intradermally injected into the neck of 10 guinea pigs on Days 0, 2, 4, 7 and 9. Animals in the control group were treated with 0.05 mL of FCA only. On Days 21 and 35, 0.025 mL of the non-irritant solutions of the test item (concentrations: 10 % or lower) were applied to the skin (2 cm2) of treated and control animals.

No skin reactions were noted at the challenge sites of the test group animals on Days 21 and 35. ACETATE DE NONYLE produced a 0 % (0/10) sensitisation rate and was considered not to be a skin sensitiser to guinea pig.

Under these test conditions, ACETATE DE NONYLE was considered not to be a skin sensitiser to guinea pig.