Biphenyl-2-ol, ethoxylated, esters with acrylic acid

Endpoint summary

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

Reference

Reference 1

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.

Reference 2

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.

Reference 3

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

Reference

Reference 1

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.

Reference 2

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.