Registration Dossier

Administrative data

Description of key information

The dermal irritation of 2-phenoxyethyl acrylate was investigated in two studies, both showing no/slight irritation. A short term study (4 hours exposure) on dermal irritation found that 2-phenoxyethyl acrylate was not irritating. In the key study (24 hour exposure study with 72 hour follow up) sligth reversible irritation was observed,, dermal reactions were observed only in two out of six animals, and with the dermal irritation index of 0.25. The major criteria for a classification as skin irritant is therefor not met.
The eye irritation of 2-phenoxyethyl acrylate was investigated in a rabbit study, showing light irrittion. The major criteria for a classification as eye irritant is therefore not met.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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
Reason / purpose:
reference to same study
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)
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..
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.
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.
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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Standard draize test with no deviations reported
Reason / purpose:
reference to same study
Qualifier:
according to
Guideline:
other: Draize: Appraisal of the safety of chemicals in foods, drugs and cosmetics. In Dermal toxicity p. 46-59 1959
Principles of method if other than guideline:
The eye irritation potential was test as described by Draize; Appraisal of the safety of chemicals in foods, drugs and cosmetics. In dermal toxicity p. 46 -59, 1959: Austin, Tex: Association of food and drug officials of the united states.
The substance was applied to one eye, and irritation score was measured after 1 hour, 24 hours, 48 hours 72 hours and 8 days.
GLP compliance:
not specified
Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
Animals were kept in steel cages, one animal per cage. 20-26C, relative humidity; 30-70%. 12:12 light:dark cycle, light from 0600 to 1800.
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1 ml undiluted
Duration of treatment / exposure:
The substance was applied once, and not washed off
Observation period (in vivo):
1 hour, 24 hours, 48 hours, 72 hours and 8 days.
Number of animals or in vitro replicates:
6 animals
Details on study design:
Untreated eye served as control
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 hours
Score:
ca. 1
Max. score:
1
Reversibility:
fully reversible
Irritant / corrosive response data:
After 24 hours no effects were observed in stratum corneum, or iris. All six animals showed light increased redness in conjuctival tissue, without swelling, but two animals showed light secretion. After 48 hours only one animal showed increased redness in conjuctival tissue, no other effetcs were observed. no effects were seen at later time points, the eye irritation effects were therefore fully reversible.
Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: US CPSC / US FDA
Conclusions:
2-phenoxyethyl acrylate is slightly irritating to the rabbits eye when applied undiluted. The irritating effect were observed as slightly increased redness of conjuctival tissue, and the effect were fully reversible within 48 hours.
Executive summary:

The eye irritation potential of 2 -phenoxyethyl acrylate were investigated in rabbits following the draize test. The substance was shown to be slightly irritating, but fully reversible after 48 hours.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The available experimental data suggest that 2-phenoxyethyl acrylate is not corrosive, as all observed effects were fully reversible.

The key study on dermal irritation found that only two of six animal had dermal reactions, leading to a primary irritation index of 0.25. The major criteria for classification as irritant is therefore not met ( at least two of three animals, with a mean score between 2.3 to 4.0). Supplementary information from another non-GLP skin irritation study in rabbits (BASF_1982) showed reactions to intact and abreaded skin. After 8 days, erythema (score 2; max score 3) was not reversible in 2/6 animals on intact skin. In contrast, edema (score 1.6; max score 3) was fully reversible after 8 days in all animals. For erythema (score 2.5; max score 3) was not fully reversible on abreaded skin after 8 days (3/6).

The data from the study available on eye irritation (BASF_1981) shows that all animals have ligth redness, score 1, which is fully reversible after 48 hours, where only one animal show ligthly increased redness. Supplementary information from another non-GLP eye irritation study in rabbits (BASF_1982) shows a max conjunctivae scores of 1 (medium of 0.39) which was fully reversible within the observation period.


Justification for selection of skin irritation / corrosion endpoint:
This is the most recent study, performed according to GLP, and of longer duration than the study from 1994

Justification for selection of eye irritation endpoint:
The only study available on eye irritation

Effects on skin irritation/corrosion: slightly irritating

Effects on eye irritation: slightly irritating

Justification for classification or non-classification

A short term study (4 hours exposure) on dermal irritation found that 2-phenoxyethyl acrylate was not irritating. In the key study (24 hour exposure study with 72 hour follow up) sligth reversible irritation was observed,, dermal reactions were observed only in two out of six animals, and with the dermal irritation index of 0.25. The major criteria for a classification as skin irritant is therefor not met.

For classification as an eye irritant the criteria are also not met, as reactions observed were fully reversible, and mean scores following grading 24, 48, and 72 hours were lower than the criteria set in table 3.3.2 in Regulation (ec) 1272/2008.