Phenol, ethoxylated, esters with acrylic acid

Endpoint summary

Description of key information

Data on the read-across substance 2-phenoxyethyl acrylate demonstrate a low acute oral and dermal toxicity.

See attached read-across justification in section 13.

No inhalation study is available.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

two doses were used

Principles of method if other than guideline:

acute toxicity study with one oral exposure, dose levels at 2150 and 5000 mg/kg.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

5 males and 5 females per concentration, approximately 12 weeks at start. At least one week acclimatization.
Food; SSNIFF R; FA.SSNIFF, Versuchstierdiaeten; 4470 Soest

Route of administration:

oral: gavage

Vehicle:

olive oil

No. of animals per sex per dose:

5

Control animals:

no

Key result

Sex:

male/female

Dose descriptor:

LD0

Effect level:

5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed

Clinical signs:

other: At highest dose, 5000 mg/kg bw; Dyspnea, staggering and overall bad condition were observed after one hour and untill 2 days. Shaggy fur was observed between 1 and 13 days. Apathy, anormalous behavior, signs of pain, spastic walking, redness of skin, dry

Interpretation of results:

sligthly toxic

Remarks:

Migrated information

Conclusions:

No mortality were observed in any of the two doses tested. The acute LD50 value is therefore above 5000 mg/kg

Executive summary:

The acute toxicity of phenoxyethyl acrylate was tested in a single dose acute toxicity test, comparable to OECD Guideline 401. Two doses were tested 2150 and 5000 mg/kg. The substance was giving orally dissolved in olive oil, total volume was 5 and 10 ml/kg bw, which is acceptable according to the OECD guideline. Several clinical signs were observed, such as dyspnoea, shaggering, shaggy fur, redness of skin and hemi paralysis. The symptoms gradually ceased within hours to two days, except shaggy fur in the highest dose. No mortality was observed at any of the doses, therefore the acute LD50 value is above 5000 mg/kg.

Reference 2

Endpoint:

acute toxicity: oral

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

Data on target substance not available. Thus, read-across has been applied using data from the source substance 2-phenoxyethyl acrylate (S1).
See further read-acoss justification in attached document to section 13.

Reason / purpose for cross-reference:

read-across source

Key result

Sex:

male/female

Dose descriptor:

LD0

Effect level:

5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: data on read-across substance

Executive summary:

No data is available for Phenol, ethoxylated, esters with acrylic acid (T).

From acute oral toxicity testing of 2 -phenoxyethyl acrylate in accordance with OECD 401 no mortality was observed for male/female rats at the highest tested dose 5000 mg/kg bw, thus LD50>5000 mg/kg bw. Due to structural and pysico-chemical similarity to Phenol, ethoxylated, esters with acrylic acid, a LD50 >5000 mg/kg bw can also be concluded for Phenol, ethoxylated, esters with acrylic acid as well.

See justification for read-across attached in section 13.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

discriminating dose

Value:

5 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was performed according to the relevant guideline under GLP conditions, inclusive certificate

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Male and female rats obtained from Harlan Olac Ltd, Bicester Oxon, England.
Rats were housed individually in metal cages with wiremesh floor. Standard rodent diet and water were provided ad libitum.
Temperature was 21C, relative humidity was 50-51%, and 12:12 light:dark period.

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Five males and five females were treated. The day before treatment, the hair was removed from the dorso-lumbar region, approximately 10% of bodysurface (5*5 cm). The test substance was applied, by spreading it evenly, and then covered by gauze, and kept in place with a non-irritative dressing, encircled firmly around the trunk.

Duration of exposure:

14 days

Doses:

2.0 g/kg

No. of animals per sex per dose:

5

Control animals:

no

Key result

Sex:

male/female

Dose descriptor:

LD0

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed during the experiment

Clinical signs:

other: No signs of systemic reactions to treatment

Gross pathology:

No macroscopic abnormalities onserved at day 15

Other findings:

Slight or well-defined erythema was observed at the site of application, for two male and three female rats on day 2. No other dermal changes and irritation has resolved at day 3.

Interpretation of results:

relatively harmless

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The substance can not be considered acutely toxic via the dermal route.

Executive summary:

Rats of both sexes were given 2 g/kg as a single dermal exposure and followed 14 days after exposure.

No mortality was observed . I addition no clinical signs nor macroscopic abnormalities were observed. A slight or well defined erythema was observed at the site of application for 2 and 3 male and females rats on day 2, respectively. No other dermal changes was observed, and irritation had resolved at day 3.

The substance can not be considered acutely toxic via the dermal route.

Reference 2

Endpoint:

acute toxicity: dermal

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

Data on target substance not available. Thus, read-across has been applied using data from source substances 2-phenoxyethyl acrylate (S1).
See further read-acoss justification in attached document to section 13.

Reason / purpose for cross-reference:

read-across source

Key result

Sex:

male/female

Dose descriptor:

LD0

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: data on read-across substance

Executive summary:

No data is available for Phenol, ethoxylated, esters with acrylic acid (M142) (T).

The acute dermal toxicity of 2-phenoxyethyl acrylate was tested in female and male rats with 2 g/kg as a single dermal exposure and followed 14 days after exposure. The test was performed in accordance with EU Method B.3. No mortality, clinical signs or abnormalities were observed. A slight or well defined erythema was observed at the site of application for 2 and 3 male and females rats on day 2, respectively. No other dermal changes was observed, and irritation had resolved at day 3 (72hours). Thus, the substance can not be considered acutely toxic via the dermal route. Due to structural and pysico-chemical similarity to Phenol, ethoxylated, esters with acrylic acid, no acute dermal toxicity be concluded for Phenol, ethoxylated, esters with acrylic acid as well.

See justification for read-across attached in section 13.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Additional information

The available studies on acute toxicity of 2-phenoxyethyl acrylate show that the substance has low acute toxicity. No mortality was observed in the studies available (oral and dermal). In the oral toxicity study using single dose levels of 2150 and 5000 mg/kg, several clinical signs of toxicity were observed including dyspnoea, shaggering, shaggy fur, redness of skin and hemi paralysis. The symptoms gradually ceased within hours to two days except for the highest dose level. In the dermal toxicity study, rats were given 2000 mg/kg as a single dermal exposure. Neither clinical signs nor macroscopic abnormalities were observed. A slight or well defined erythema was observed at the site of application on day 2. No other dermal changes were observed and irritation had resolved at day 3.

Overall, 2-phenoxyethyl acrylate demonstrates a low acute oral and dermal toxicity. No inhalation study is available.

Justification for selection of acute toxicity – oral endpoint
The study is an OECD Guideline 401 study

Justification for selection of acute toxicity – inhalation endpoint
No inhaltion study available. Annex VIII requirement for second exposure route is fulfilled as both an acute oral and an acute dermal expossure study is availabe.

Justification for selection of acute toxicity – dermal endpoint
The study was performed according to EU Method B 3, under GLP conditions

Justification for classification or non-classification

The available data on acute toxicity suggest that the read-across substance 2 -phenoxyethyl acrylate and hence also the target substance Phenol, ethoxylated, esters wit acrylid acid

should not be classified for acute toxicity.