Octyl acetate

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

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

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

Species:

human

Strain:

not specified

Sex:

not specified

Details on test animals and environmental conditions:

no data

Route:

other: no data

Vehicle:

other: Petrolatum

Concentration / amount:

8% in Petrolatum

Route:

other: no data

Vehicle:

other: Petrolatum

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

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.

The test substance was estimated to be non sensitizing.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Skin sensitization

Various studies for target (Octyl acetateCAS no-112-14-1) as well as its read across were summarized as follows:

Maximization test was carried out to find skin sensitization of Acetate C-8(112-14-1). 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.

The dermal sensitization potential of Octyl acetate was estimated using OECD QSAR toolbox v3.4. Octyl acetate(112-14-1) was estimated to be not sensitizing to Hartley guinea pigs skin.Skin sensitization effects were estimated by three different models i.e., Battery, Lead scope and Sci QSAR used within Danish QSAR database for chemical Octyl acetate. Based on estimation No sensitization were known when test chemical Octyl acetate(112-14-1) was exposed to guinea pigs and human skin.

In other study by (IFA (GESTIS) 2016) with similar substance (CAS No:124-17-4) was observed in human .The skin sensitization study of Butyl carbitol acetate(CAS No: -124-17-4)was performed in humans to determine its sensitization efficacy. Since no reactions was observed in humans, the test material Butyl carbitol acetate (CAS No: -124-17-4)wasfound to be non-sensitizing to humans.

In another study by (Philip Copestake and Mr Heath Malcolm, 2005) with similar substance (CAS No: 123-86-4) was observed in guinea pig.A guinea pig maximization test was carried out on 15 Hartley guinea pigs for test chemical n-Butyl acetate (CAS No: -123-86-4) to assess its sensitizing potency. In the maximization test, 15 Hartley strain guinea pigs were each given intradermal injections of n-butyl acetate together with an adjuvant, followed 7 days later with a 48h covered patch. A challenge patch (24h covered contact) was applied 7 days after this induction regimen. Since none of the guinea pigs showed any skin sensitization effects at challenge concentration, the test substance n-Butyl acetate(CAS No: -123-86-4) was observed to be not sensitizing to guinea pigs.

In another study by (Philip Copestake and Mr Heath Malcolm, 2005) with similar substance (CAS No: 123-86-4) was observed in guinea pig by Mouse ear swelling test.An ear swelling test was carried out on 10-15 mice for test chemical, n-Butyl acetate(CAS No: -123-86-4) to assess its sensitizing potential.

 In the mouse study, groups of 10–15 animals were given intradermal injections of an adjuvant and repeated skin applications of n-butyl acetate. After a 7day non-treatment period, a topical application of n-butyl acetate was made to one ear, the other acting as control. Ear thickness was assessed 24 h and 48 h following this challenge.  There was no known evidence of change in ear thickness at 24 and 48 hours. Hence the test substance, n-Butyl acetate(CAS No: -123-86-4) was considered to be not sensitizing to mice skin.

On the basis of available information for the target as well as read across substance and applying weight of evidence approach, the test substance can be considered as not sensitising to the skin.

Migrated from Short description of key information:

Maximization test was carried out to find skin sensitization of Acetate C-8(112-14-1). 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.

Justification for selection of skin sensitisation endpoint:

data is from peer reviewed journals

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

The test substance Octylacetateeffect was observed in various studies .Based on various studies observationOctyl acetatecan be classified as non skin sensitizer.