Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted in compliance with Code of Federal Regulations, Title 16, Section 1500.41, and under GLP conditions
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Code of Federal Regulations, Title 16, Section 1500.41
Principles of method if other than guideline:
NA
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
IRR169, clear pale yellow liquid, 100% monoethoxylated phenoxyethyl acrylate

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Weight range beteen 2.4 and 4.0 kg bw, Age between 10 to 20 weeks. Housed individually in metal cages. Standard laboratory diet, SQC Rabbit Diet and drinking water ad libitum. Temperature 13.5-23 C, relative humidity 45-73%. Air exchange approximately 19 changes per hour. 12 hour artificial light from 0700 to 1900..

Test system

Type of coverage:
semiocclusive
Preparation of test site:
abraded
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 ml was applied under 25*25mm gauze pads to one intact and one abraded skin site.
Duration of treatment / exposure:
24 hours
Observation period:
24 and 72 hours
Number of animals:
6.

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24 h
Score:
>= 0.25
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
At 24-hours reading very slight erythema with or without very slight oedema was seen at one intact and one abraded site. At 72-hour reading these reaction had resolved, and very slight erythema with or without very slight oedema was observed at another intact and abraded site.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: US CPSC / US FDA
Conclusions:
A single occlusive application of 2-phenoxyethyl acrylate to intact and abraded rabbit skin for 24 hours elicited very slight dermal irritation, primary irritation index was calculated to 0.25, and only two out of six animals showed dermal reactions. the substance should therefore not be classified as
irritating.
Executive summary:

The skin irritation potential of 2-phenoxyethyl acrylate was investigated on intact and abraded skin on rabbits. A single occlusive application for 24 hours elicited very slight dermal irritation, in two out of six animals. Primary irritation index was calculated to be 0.25. and 2-phenoxyethyl acrylate is therefore not a skin irritant. Hence, no classification is needed.