Hexyl acrylate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Data source

Reference

Reference Type:

publication

Title:

Range-finding toxicity data: List VII

Author:

Smyth HF, Carpenter CP, Weil CS, Pozzani UC, Streigel JA and Nycum JS,

Year:

1969

Bibliographic source:

American Industrial Hygiene Association Journal 30, 470-476

Materials and methods

Principles of method if other than guideline:

Primary skin irritation on rabbits is recorded in a 10-grade ordinal series and is based upon the severest reaction that develops on the clipped skin of each of five New Zealand albino rabbits within 24 hours of the uncovered application of 0.01 mL of undiluted sample.

GLP compliance:

no

Remarks:

Study predates GLP

Test material

Test material information

Constituent 1

Reference substance name:

Hexyl acrylate

EC Number:

219-698-5

EC Name:

Hexyl acrylate

Cas Number:

2499-95-8

Molecular formula:

C9H16O2

IUPAC Name:

hexyl prop-2-enoate

Specific details on test material used for the study:

Specific details not provided

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Details on test animals and environmental conditions not provided

Test system

Type of coverage:

open

Preparation of test site:

clipped

Vehicle:

not specified

Remarks:

General method indicates vehicle could be water, propylene glycol or acetone

Controls:

not required

Amount / concentration applied:

0.01 mL of undiluted sample or solutions in water, propylene glycol, or acetone.

Duration of treatment / exposure:

Duration of treatment/exposure: 24 h

Observation period:

Observation period: 24 h

Number of animals:

5 Albino Rabbits

Details on study design:

Chemical was applied in 0.01 ml, amounts to clipped, uncovered intact skin of 5 rabbits either undiluted or in progressive dilutions of 10, 1, 0.1, and 0.01% in solvent. Ten grades are recognized based on appearance of moderate or marked capillary, erythema, edema or necrosis within 24 hours.

Grade 1 indicates no irritation and Grade 2 the least visible capillary injection from the undiluted chemical. Grade 6 indicates necrosis when undiluted and Grade 10 indicates necrosis from a 0.01% solution.

Results and discussion

In vivo

Results

Irritation parameter:

other: Irritation Grade based on scale in Carpenter et al. (1946)

Basis:

mean

Time point:

24 h

Score:

5

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Irritant / corrosive response data:

Irritation grade 6.0 indicates necrosis when undiluted, therefore a score of grade 5.0 is indicative of irritation if not minimal necrosis.

Applicant's summary and conclusion

Interpretation of results:

other: Category 2 (irritant) based on physiologic description

Conclusions:

Based on the irritation score of Grade 5.0, which corresponds to Necrosis, n-hexyl acrylate is considered irritating to the skin.

Executive summary:

N-hexyl acrylate produced a skin irritation or corrosion score of Grade 5.0 (irritation/minimal necrosis) following 24 hour open application of 0.1 mL to 5 New Zeland White rabbits. While direct comparison of the grading shceme used in this study to current GHS criteria is not possible, this finding, evaluated within a weight of evidence approach, supports classification of N-hexyl Acrylate as a Category 2 Skin Irritant under the Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).