Nonyl acetate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

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; irritation scores in individual animal was not reported; half volume was applied (0.025 mL instead of 0.5 mL).

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:

Method: In the single and repeated applications tests, different concentrations of the test item were applied to the clipped flank skin of guinea pigs and the application sites were observed for skin reactions.

GLP compliance:

no

Remarks:

pre-GLP

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)

Test animals

Species:

guinea pig

Strain:

not specified

Details on test animals or test system and environmental conditions:

None

Test system

Type of coverage:

open

Preparation of test site:

clipped

Vehicle:

other: ethanol

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (weight with unit): 0.025 mL (single application test) and 0.1 mL (repeated applications test)
- Concentration (if solution): 100, 30, 10 and 3 % or lower in ethanol

Duration of treatment / exposure:

- Single application test: 24 h
- Repeated applications test: Once daily for 3 weeks

Observation period:

- Single application test: 24 h
- Repeated applications test : 21 days

Number of animals:

6 guinea pigs/group

Details on study design:

ACUTE TEST:
- Estimation of threshold-toxic concentration: One day before starting the induction procedure, 0.025 mL of each test concentration (100, 30, 10 and 3 % or lower in ethanol) was applied directly to the clipped flank skin (2 cm2) of the guinea pigs and the skin reactions were observed after 24 h. The minimal irritant and the maximal non-irritant concentrations were determined by an all-or-none criterion.

REPEATED APPLICATIONS TEST
- No. of exposures: 21
- Test groups: 0.1 mL of each test concentration was applied directly to the skin of animals and the application sites were left uncovered.
- Site: Clipped flank skin (8 cm2)
- Frequency of applications: Once daily for 3 weeks
- Evaluation of skin reactions: 24 h after application or at the end of each week
- Duration: Days 0-20

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 24h, 7 day, 21 day

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritant / corrosive response data:

- Single and repeated applications of ACETATE DE NONYLE (10 % in ethanol) were well tolerated.
- After a single application, the lowest irritant concentration was 30 % in ethanol and the highest non-irritant concentration was 10 % in ethanol.

Other effects:

None

Any other information on results incl. tables

No irritation

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

A single applications of ACETATE DE NONYLE 10% in ethanol were well tolerated. Higher concentrated solutions caused slight skin irritation.

Executive summary:

In an acute dermal irritation study (non-GLP study), 0.025 mL of the test item, ACETATE DE NONYLE, was applied directly to the clipped flank skin (2 cm2) of groups of guinea pigs (6/group) at concentrations of 100, 30, 10 and 3 % or lower in ethanol. The application site was left uncovered and observed for dermal reactions after 24 h.

Single and repeated applications of ACETATE DE NONYLE 10% in ethanol were well tolerated. Higher concentrated solutions caused slight skin irritation. However these observations are not sufficient for classification.