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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

No data is available on Biphenyl-2-ol, ethoxylated, esters with acrylic acid (M1142) (T).

Skin irritation:

 A study (4 hours exposure) on dermal irritation in rabbits found that 2-phenoxyethyl acrylate was not irritating. In the key study (24 hour exposure study with 72 hour follow up) slight 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 criteria for classification for skin irritation was not met.

Eye irritation:

Also, the eye irritation of 2-phenoxyethyl acrylate was investigated in a rabbit study, showing slight irritation. The criteria for classification for eye irritation was not met. The same low eye irritation potential would be expected for Biphenyl-2-ol, ethoxylated, esters with acrylic acidas well.

 

Based on these data a lack of potential for both skin and eye irritation can be considered for Biphenyl-2-ol, ethoxylated, esters with acrylic acid as well.

 See justification for read-across attached in section 13.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
The hypothesis for a read-across approach from data on 2-phenoxyethyl acrylate to o-phenylphenolethyl acrylate is the similarity of the chemical structures and physical chemical properties of the two substances.
See attached read-across justification in section 13
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24 h
Score:
>= 0.25
Reversibility:
fully reversible within:
Remarks:
72 hours
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not relevant
Interpretation of results:
GHS criteria not met
Conclusions:
No data is available on Biphenyl-2-ol, ethoxylated, esters with acrylic acid
 
A study (4 hours exposure) on dermal irritation in rabbits found that 2-phenoxyethyl acrylate was not irritating. In the key study (24 hour exposure study with 72 hour follow up) slight 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 criteria for classification for skin irritation was not met.

Based on these data a lack of potential for skin irritation can be considered for Biphenyl-2-ol, ethoxylated, esters with acrylic acid as well.
 See justification for read-across attached in section 13.
Executive summary:

No data is available on Biphenyl-2-ol, ethoxylated, esters with acrylic acid (M1142) (T).

 

A study (4 hours exposure) on dermal irritation in rabbits found that 2-phenoxyethyl acrylate was not irritating. In the key study (24 hour exposure study with 72 hour follow up) slight 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 criteria for classification for skin irritation was not met.

Based on these data a lack of potential for skin irritation can be considered for Biphenyl-2-ol, ethoxylated, esters with acrylic acid as well.

 See justification for read-across attached in section 13.

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was performed according to guideline, under GLP conditions, including certificate.
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Animals were obtained from Froxfield (U.K.) Ltd., Petersfield, Hampshire, England
Age was 11-13 weeks and weight range was 2.6-2.9 kg.
Rabbits were fed a standard rabbit diet and drinking water ad libitum.
Animal room temperature was 19C
relative humidity was 30-70%
Air exchange was approximately 19 times an hour.
lightning was 12:12 dark light, light from 0700 to 1900.
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 ml of the test substance was applied under a 25*25 mm gauze pad, covered with Elastoplast adhesive dressing.
Duration of treatment / exposure:
4 hours
Observation period:
day 1 to day 4 (72 hours after exposure)
Number of animals:
3
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 hours
Score:
0
Max. score:
0
Reversibility:
other: Not relevant
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 48 hours
Score:
0
Max. score:
0
Reversibility:
other: Not relevant
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 Hours
Score:
0
Max. score:
0
Reversibility:
other: Not relevant
Other effects:
No signs of toxicity or ill health
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
The substance 2-phenoxyethyl acrylate showed no irritation potential to rabbits, following OECD guideline 404. 2-phenoxyethyl acrylate is therefore not a skin irritant.
Executive summary:

A study was performed to assess the skin irritation potential of 2-phenoxyethyl acrylate to the rabbit. The method followed was OECD Guidelinne 404 and EU Method B.4.

No reactions were observed following 4 hours exposure. Total mean score was calculated to be 0, and the substance should therefore not be labelled irritating to skin.

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
Qualifier:
according to guideline
Guideline:
other: Code of Federal Regulations, Title 16, Section 1500.41
Principles of method if other than guideline:
NA
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system 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
Max. score:
1
Reversibility:
fully reversible within: 72 h
Remarks on result:
probability of mild irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
not fully reversible within:
Remarks:
72h
Remarks on result:
probability of mild irritation
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within:
Remarks:
72h
Remarks on result:
probability of mild irritation
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: 72
Remarks on result:
probability of mild irritation
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 72
Remarks on result:
probability of mild irritation
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
0
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.
Other effects:
NA
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

Referenceopen allclose all

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 for cross-reference:
reference to same study
Qualifier:
according to guideline
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:
eye irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
The hypothesis for a read-across approach from data on 2-phenoxyethyl acrylate to o-phenylphenolethyl acrylate is the similarity of the chemical structures and physical chemical properties of the two substances.
See attached read-across justification in section 13
Reason / purpose for cross-reference:
read-across source
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24 h
Score:
1
Max. score:
1
Reversibility:
fully reversible
Executive summary:

No data is available for Biphenyl-2-ol, ethoxylated, esters with acrylic acid (T).

 

The eye irritation of 2-phenoxyethyl acrylate was investigated in a rabbit study, showing slight irritation. The criteria for classification for eye irritation was not met. The same low eye irritation potential would be expected for Biphenyl-2-ol, ethoxylated, esters with acrylic acidas well.

 

See justification for read-across attached in section 13.

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).

The data from the study available on eye irritation shows that all animals have ligth redness, score 1, which is fully reversible after 48 hours, where only one animal show ligthly increased redness. The major criteria for classification as irritant is therefore not met


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.