Oxybis(2,1-ethanediyloxy-2,1-ethanediyl)diacrylate

Endpoint summary

Description of key information

An oral acute toxicity study is available on Tetraethylene Glycol Diacrylate in rats and shows a LD50 of 641 mg/kg.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

June / July 1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

no guideline followed

Principles of method if other than guideline:

5 female and 5 male rats were treated with the test item for one oral administration (gavage) et the doses of 316; 464, 681 and 1000 mg/kg bw. The item was dissoved in water.
The animals were checked every day during 14 days after administration. At the end of the study, the animals were weighed and necropsied.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

Sprague-Dawley

Details on test animals or test system and environmental conditions:

- Fasting period before study: yes 15h-20h before administration
-diet : HERILAN MRH-HALTUNG;H.EGGERSMANN KG

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

Administration volume : 10 ml/kg

Doses:

100, 681, 464, 316 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days

Statistics:

no

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

641 mg/kg bw

Based on:

test mat.

95% CL:

> 516 - < 832

Mortality:

-At 1000 mg/kg : males = 4/5 died (at Day 1 after administration) ; females = 4/5 died (at Day 1 after administration) ; total : 8/10
-At 681 mg/kg : males = 4/5 (3 rats at day 1, 1 rat at day 7) ; females = 2/5 died (at Day 1 after administration) ; total : 6/10
-At 464 mg/kg : males = 1/5 (at day 1) ; females = 2/5 died (at Day 7 after administration) ; total : 3/10
-At 316 mg/kg : males = 0/5 ; females = 0/5

Clinical signs:

other: -At 1000 mg/kg : dyspnea, apathie, coarse fur -At 681 mg/kg : dyspnea, apathie, coarse fur -At 464 mg/kg : dyspnea, apathie, anemia, coarse fur -At 316 mg/kg : dyspnea, apathie

Gross pathology:

Died animal : Heart: Right of acute dilation; Stomach: liquid content, gastric mucosa glandular very red (haemorrhagic gastritis); Thorax / abdomen: liquid; Liver
Alive animal : Adhesions of the premature with liver and peritoneum, fliverticle formation

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

Based on the data, the oral DL50 of the test article is 641 mg/kg in rats.

Executive summary:

5 female and 5 male rats were treated with the test item for one oral administration (gavage) et the doses of 316; 464, 681 and 1000 mg/kg bw. The item was dissoved in water.

The animals were checked every day during 14 days after administration. At the end of the study, the animals were weighed and necropsied.

Mortalities were observed at the doses of 464 mg/kg (3/10), 681 mg/kg (6/10) and 1000 mg/kg (8/10). Some clinical signs were observed in all treated animals ( dyspnea, apathie).

No changes of bodyweight were observed. Some macroscopic effects were observed at the necropsy on liver, stomach, abdomen.

Based on the data, the oral DL50 of the test article is 641 mg/kg in rats.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

641 mg/kg bw

Quality of whole database:

The study is considered to be reliable with a klimisch score of 2.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Oral acute toxicity study (1979) :

5 female and 5 male rats were treated with the test item for one oral administration (gavage) et the doses of 316; 464, 681 and 1000 mg/kg bw. The item was dissoved in water.

The animals were checked every day during 14 days after administration. At the end of the study, the animals were weighed and necropsied.

Mortalities were observed at the doses of 464 mg/kg (3/10), 681 mg/kg (6/10) and 1000 mg/kg (8/10). Some clinical signs were observed in all treated animals ( dyspnea, apathie).

No changes of bodyweight were observed. Some macroscopic effects were observed at the necropsy on liver, stomach, abdomen.

Based on the data, the oral DL50 of the test article is 641 mg/kg in rats.

Justification for classification or non-classification

Based on the available data, a classification of tetraethyleneglycol diacrylate is required for acute toxicity according to the Regulation EC n°1272/2008 : Harmful if swallowed (Acute tox 4, H302).

Justification: the oral LD50 is between 300 and 2000 mg/kg bw.