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Toxicological information

Skin irritation / corrosion

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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

Constituent 1
Chemical structure
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).