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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye 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, Carrol SW, Urbano CP, Streigel JA, Nycum JS
Year:
1969
Bibliographic source:
Am. Ind. Hyg. Assoc. J. Vol 30, 470-476

Materials and methods

Principles of method if other than guideline:
Eye injury in rabbits is recorded in a 10 grade ordinal series and is based upon the degree of corneal necrosis that results from single instillation of 0.5 ml undiluted test substance into conjunctival sac of 5 rabbits. Read immediately unstained and after fluoroscein at 24 hours, with ten grades recognized
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

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source:
- Age at study initiation:
- Weight at study initiation:
- Housing:
- Diet (e.g. ad libitum):
- Water (e.g. ad libitum):
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
Duration of treatment: 24 h
Number of animals or in vitro replicates:
5 Rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing
- Time after start of exposure:

SCORING SYSTEM: Grade 1 indicates at most a very small areas of necrosis resulting from 0.5 mL undiluted chemical in the eye. Grade 5 indicates a severe burn from 0.005 mL undiluted and Grade 10 indicates a severe burn from 0.5 mL of a 1% solution in water or propylene glycol.

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results
Irritation parameter:
other: Irritation grade based on Carpenter et al. (1946)
Basis:
mean
Time point:
24 h
Score:
1
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Irritant / corrosive response data:
Grade 1.0 corresponds to Necrosis on less than 5% of cornea

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
Based on the irritation score of Grade 1.0, which corresponds to Necrosis on less than 5% of cornea, n-hexyl acrylate is considered irritating to the eye.
Executive summary:

N-hexyl Acrylate produced evidence of eye irritation in an in-vivo rabbit assay. This finding supports classification of N-hexyl Acrylate as a Category 2 Eye Irritant under the Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).