Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Acute oral toxicity:

Ethoxyethoxyethyl acrylate (EOEOEA) was reported to have an oral LD50 = 1850 mg/kg bw in rats whereas the Danish QSAR database predicted an oral LD50 = 900mg/kg bw in rats for the substance. Based on this information EOEOEA is expected to have an oral LD50 in the range between 900 -1850 mg/kg bw and therefore meets the criteria for Acute Tox. 4 classification (300< x ≤2000 mg/kg bw) according to the CLP regulation 1272/2008.

 

Acute dermal toxicity:

The dermal LD50 values of EOEOEA in male and female Wistar rats was established according to OECD Guideline 402 (Acute Dermal Toxicity) and observed to be within the range of 400-2000 mg/kg bw.

In another OECD 402 study male rabbits had a LD50 –value in the range of 1000-2000 mg/kg bw and for females LD50 >2000 mg/kg bw.

According to the CLP regulation 1272/2008 the dermal LD50 value obtained in rats meets the criteria for the classification as Acute Tox 3; H311 (200< x ≤1000 mg/kg bw).

No data available on inhalational toxicity of EOEOEA.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
other: Scientific research article
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Qualifier:
no guideline available
Principles of method if other than guideline:
No information available on guideline used in the oral LD50 study reported by Gold The study is part of company data
GLP compliance:
not specified
Test type:
other: not specified
Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
NA
Route of administration:
oral: gavage
Vehicle:
not specified
No. of animals per sex per dose:
NA
Control animals:
not specified
Statistics:
NA
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
1 860 mg/kg bw
Based on:
test mat.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
900 mg/kg bw
Based on:
other: QSAR prediction,
Remarks:
Reliability Index=0.82

Results are based on

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
Ethoxyethoxyethyl acrylate (EOEOEA) was reported to have an oral LD50 = 1850 mg/kg bw in rats whereas QSAR predicted an oral LD50 = 900mg/kg bw in rats. Based on these information EOEOEA is expected to have an oral LD50 between 900 -1850 mg/kg bw and therefore meets the criteria for Acute Tox. 4 classification (300< x ≤2000 mg/kg bw) according to the CLP regulation 1272/2008.
Executive summary:

Ethoxyethoxyethyl acrylate (EOEOEA) was reported to have an oral LD50 = 1850 mg/kg bw in rats whereas QSAR predicted an oral LD50 = 900mg/kg bw in rats. Based on these information EOEOEA is expected to have an oral LD50 in the range between 900 -1850 mg/kg bw and therefore meets the criteria for Acute Tox. 4 classification (300< x ≤2000 mg/kg bw) according to the CLP regulation 1272/2008.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
900 mg/kg bw
Quality of whole database:
Weight of evidence using the LD50-value from an QSAR prediction (klimish score 1) and the LD50 from one experimental study (klimish score 2). The lowest effect level is used (a conservative estimate) using the QSAR prediction estimate. quteria for classification

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Oct 1996 - Jan 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was performed according to the relevant guidance on dermal toxicity, OECD 402.
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
no
Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
Animals were received from Ace Animals, Boyertown, PA. Following the quarantine period of at least one week, five healthy male and five non-pregnant, nulliparous, healthy female were randomly assigned to the treatment groups.The pretest body weight range was 2.0-2.5 kg for males and 2.0-2.6 kg for females. the w eight variation of the animals used did not exceed +/- 20% of the mean body weight.
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
The test artice was used as received. It had been applied to the clipped site by a syringe at 1000 mg/kg bw and 2000 mg/kg bw. The doses were based upon the sample weight as calculated from the specific gravity. The test article was applied on the top of a four layered surgical gauze patch measurig 10x15cm. *Gentle pressure was applied to the gauze to aid in the distribution of the test substance over the prepared site. The torso was wrapped with plastic which was secured with non-irritating tape. The test article remained in contact with the skin for 24 hours at which time the wrappings were removed. Residual test article was removed by gentle washing with distilled water.
Duration of exposure:
24 hrs
Doses:
1000 mg/kg bw and 2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
- Duration of observation period following administration: The animals were observed 1, 2 and 4 hours postdose and once daily for 14 days for toxicity and pharmacological effects. The animals were observed twice daily for 14 days for mortality. The test sites were scored for dermal irritation at 24 hrs postdose and on days 7 and 14 using the numerical Dreize scoring code.
- Frequency of weighing: Body weights were recorded pretest, weekly and at death, or termination of the survivors.
- Necropsy of survivors performed: All animals were examined for gross pathology. Abnormal tissues were preserved in 10% buffered formalin for possible future microscopic examination.
Statistics:
None: the estimate of the LD50 was made based on the survivals during the study.
Sex:
male
Dose descriptor:
LD50
Effect level:
> 1 000 - < 2 000 mg/kg bw
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
Dose group 1000 mg/kg bw
females 0/5
males 0/5
Dose group 2000 mg/kg bw
females 1/5
males 3/5
Clinical signs:
other: Lethargy, soiling on the anogenital area, ataxia, flaccid muscle tone, emaciation, wetness of the nose/mouth and breathing difficulties.
Gross pathology:
Animals died during the study revealed abnormalities of the lungs, dosed site, liver and gastrointestinal tract as well as wetness of the nose/mouth and anogenital area, emacination and soiling of the anogenital area. Necropsy of survivors revealed abnormalities of the treated skin, kidneys, liver, lungs, intestines, peritoneal cavity and soiling of the anogenital area.
Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 is greater than 2000 mg/kg body weight for female rabbits
The LD50 is in the range of 1000 - 2000 mg/kg bw for male rabbits.
Fullfil the criteria for classification as Acute Tox 4; H312
Executive summary:

An OECD 402 study was perfomed with rabbits (5 males, 5 females) at dose levels of 1000 mg/kg bw and 2000 mg/kg bw.

The LD50 was greater than 2000 mg/kg body weight for female rabbits

The LD50 was in the range of 1000 - 2000 mg/kg bw for male rabbits.

The LD50 value for male rabbits fullfils the criteria for classification as Acute Tox 4; H312.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
400 mg/kg bw
Quality of whole database:
Two acute dermal toxicity of high quality available (one in rats, one in rabbits) and both highly reliable. The study in rabbits performed with the most narrow dose inteval giving the most adequate data for the classification.

Additional information

Justification for selection of acute toxicity – dermal endpoint
This study uses the cutt-off points from the classification criteria as the relevant dose levels.

Justification for classification or non-classification

The oral LD50 is in the range of 900 - 2000 mg/kg bw for male and female rats and fulfils the criteria for classification as Acute Tox 4; H302 .

The dermal LD50 is in the range of 400 - 2000 mg/kg bw for male and female rats and therefore fulfils the criteria for classification as Acute Tox 3; H311

The dermal LD50 is greater than 2000 mg/kg body weight for female rabbits

The dermal LD50 is in the range of 1000 - 2000 mg/kg bw for male rabbits.

The dermal LD50 value for male rabbits fulfils the criteria for classification as Acute Tox 4; H312