Fatty acids, C16 and C18-20 (even numbered, unsaturated), 2-ethylhexyl esters

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation / corrosion

Remarks:

other: human repeat insult patch test

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1977

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

A limited synopsis of the data, generated prior to adoption of GLP or standard regulatory guidelines, is available for a human repeat insult patch test for a similar material - ethylhexyl palmitate. For all of these reasons the relevance of the information to the skin irritancy of fatty acids, C12-20 and C12-20 unsaturated, 2-ethylhexyl esters is not assignable.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

25 healthy human volunteers wee exposed to five 48 hour persiods of induction exposure folloed by a ten day rest period and then challenge application by 48hour occluded topical exposure. Reactions were observed and assessed immediately and 24 hours after challenge patch removal

The method was outlined as the Maximisation test by Professor Klignman in J.I.D. Vol 47: No 5: 393-409 "Updataing the Maximisation Test for Identifying Contact Allergens" - Contact Dermatitis, 1975; 1:231-239

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

ethylhexyl palmitate

IUPAC Name:

ethylhexyl palmitate

Details on test material:

- Name of test material (as cited in study report): ethyl hexyl palmitate RIFM# 77-4-478

Test animals

Species:

human

Strain:

not specified

Details on test animals or test system and environmental conditions:

25 healthy human volunteers - adult males (12) and females (13) in the age range 18-30 years, all but five were Caucasian.

No information given relating to environmental conditions but assumed to be normal home environments except on dosing days

Test system

Type of coverage:

occlusive

Preparation of test site:

other: pretreated by application of 2.5% aqueous sodium lauryl sulphate

Vehicle:

not specified

Controls:

no

Amount / concentration applied:

No details available for dose of test material applied in induction or challenge phases

Duration of treatment / exposure:

Five 48-hour periods of occluded exposure by topical application to forearm or dorsum, followed by 10 day rest period and then a 48 hour exposure under occlusive dressing to a naive site.

Observation period:

immediately and 24 hours after challenge dressing removal

Number of animals:

25 human volunteers

Details on study design:

TEST SITE
- Area of exposure: Not specified in study synopsis
- % coverage: Not stated
- Type of wrap if used: occlusive dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not stated

SCORING SYSTEM: Not stated but method details indicate a modified Draize assessment

Results and discussion

Any other information on results incl. tables

The reactions for all 25 volunteers immediately and 24 hours after challenge were scored as "0" for irritation/sensitisation

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Conclusions:

In this human repeat insult patch test, ethyl hexylpalmitate was applied to 25 healthy adult volunteers on five occasions during induction and then 10 days later a topical challenge dose was applied. No signs of sensitisation or irritation were observed.

Executive summary:

In this human repeat insult patch test, ethyl hexylpalmitate was applied to 25 healthy adult volunteers on five occasions during induction and then 10 days later a topical challenge dose was applied. No signs of sensitisation or irritation were observed.