Octyl acetate

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation

Remarks:

in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: data is from peer reviewed journals

Data source

Reference

Reference Type:

publication

Title:

Fragrance raw materials monographs: Acetate C-8

Author:

Edited by D. L. J. Opdyke

Year:

1974

Bibliographic source:

Food and Cosmetics Toxicology Volume 12, pg 815, December 1974

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

Maximization test was carried out to find skin sensitization of Acetate C-8 in human.

GLP compliance:

not specified

Type of study:

other: Human Maximization test

Test material

Test material information

Constituent 1

Reference substance name:

Octyl acetate

EC Number:

203-939-6

EC Name:

Octyl acetate

Cas Number:

112-14-1

Molecular formula:

C10H20O2

IUPAC Name:

octyl acetate

Test material form:

other: liquid

Details on test material:

Name of test material (as cited in study report): Octyl acetate
- Molecular formula:C10H20O2
- Molecular weight:172.27 g/mol
- Smiles notation: C(CCCCCC)COC(C)=O
- InChI: 1S/C10H20O2/c1-3-4-5-6-7-8-9-12-10(2)11/h3-9H2,1-2H3
-Substance type: Organic
-Physical State: Liquid

In vivo test system

Test animals

Species:

human

Strain:

not specified

Sex:

not specified

Details on test animals and environmental conditions:

no data

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

other: no data

Vehicle:

other: Petrolatum

Induction 2

Concentration / amount:

8% in Petrolatum

Challenge

Challenge 1

Route:

other: no data

Vehicle:

other: Petrolatum

Challenge 2

Concentration / amount:

8% in Petrolatum

No. of animals per dose:

24

Details on study design:

Details on study design
RANGE FINDING TESTS: No data

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: No data
- Exposure period: No data
- Test groups: No data
- Control group: No data
- Site: No data
- Frequency of applications: No data
- Duration: No data
- Concentrations: 8%

B. CHALLENGE EXPOSURE
- No. of exposures: No data
- Day(s) of challenge: No data
- Exposure period: No data
- Test groups: No data
- Control group: No data
- Site: No data No data
- Concentrations:
- Evaluation (hr after challenge): No data

Challenge controls:

No data

Positive control substance(s):

not specified

Results and discussion

In vivo (non-LLNA)

Results

Reading:

1st reading

Group:

test chemical

Dose level:

8% in petrolatum

No. with + reactions:

0

Clinical observations:

no effects were observed

Remarks on result:

other: Reading: 1st reading. Group: test group. Dose level: 8% in petrolatum. No with. + reactions: 0.0. Clinical observations: no effects were observed.

Any other information on results incl. tables

The test substance was estimated to be non sensitizing.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Conclusions:

The substance Acetate C-8 can be considered as non-sensitizing to human at 8% concentration in petrolatum.

Executive summary:

Maximization test was carried out to find skin sensitization ofAcetate C-8. The test was carried out on 24 volunteers. The material Acetate C-8 was tested at a concentration of 8% in petrolatum, no sensitization reaction was observed. Therefore,the substance Acetate C-8 can be considered as non-sensitizing to human.