Poly[oxy(methyl-1,2-ethanediyl)], α-hydro-ω-hydroxy-, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1), 2-propenoate

Endpoint summary

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:

From June 08, 2016 to June 23, 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

Source: Velaz Prague, Czech Republic
Age at first dose: 8-12 weeks
Acclimation: 5 days prior to the start of treatment
Room temperature: 22 ± 2° C, relative humidity: 55 ± 10%
The light regimen was set to a 12-hour light /12-hour dark cycle
Diet: laboratory food Altromin (Altromin Spezialfutter GmbH, Germany), water: tap water

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

The required amount of the test substance (according to the body weight and dose) was mixed with vehicle (olive oil) shortly before administration. The test substance was administered in a single dose by gavage using a metal stomach tube. Animals were fasted prior to dosing (food but not water were withheld over-night). Following the period of fasting, the animals were weighted and the test substance administered. After the test substance had been administered, food was withheld for further 3-4 hours.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6

Control animals:

no

Key result

Sex:

female

Dose descriptor:

LD0

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

All 6/6 females survived the limit dose of 2000 mg/kg

Clinical signs:

other: Animals lived through observation period without signs of intoxication. Neither change of health nor negative reactions were registered

Gross pathology:

All animals were necropsied. During necropsy, no macroscopic changes were noticed

Interpretation of results:

GHS criteria not met

Conclusions:

Under the study conditions, the LD50 of the test substance was > 2000 mg/kg bw after single oral administration to rats.

Executive summary:

A study was conducted to determine the acute oral toxicity of the test substance according to OECD Guideline 423 (acute toxic class method), in compliance with GLP. The substance was administered by oral gavage to six female Wistar rats at 2000 mg/kg bw. Treated animals were observed for mortality, clinical signs and body weight changes for 14 d and were then subjected to gross pathological examination. No mortality was observed during the study. Animals lived through the observation period without signs of intoxication. Neither changes of health nor negative reactions were recorded. No body weight losses were observed in the first and second week after administration. In 2 animals, stagnation of body weight was observed. All animals were necropsied and no macroscopic changes in the organs were observed. Under the study conditions, the LD50 of the test substance was > 2000 mg/kg bw after single oral administration to rats (Hozova, 2016).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

other justification

Justification for data waiving:

other:

Reason / purpose for cross-reference:

data waiving: supporting information

Reason / purpose for cross-reference:

data waiving: supporting information

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation)

Reason / purpose for cross-reference:

data waiving: supporting information

Reason / purpose for cross-reference:

data waiving: supporting information

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

A study was conducted to determine the acute oral toxicity of the test substance according to OECD Guideline 423 (acute toxic class method), in compliance with GLP. The substance was administered by oral gavage to six female Wistar rats at 2000 mg/kg bw. Treated animals were observed for mortality, clinical signs and body weight changes for 14 d and were then subjected to gross pathological examination. No mortality was observed during the study. Animals lived through the observation period without signs of intoxication. Neither changes of health nor negative reactions were recorded. No body weight losses were observed in the first and second week after administration. In 2 animals, stagnation of body weight was observed. All animals were necropsied and no macroscopic changes in the organs were observed. Under the study conditions, the LD50 of the test substance was > 2000 mg/kg bw after single oral administration to rats (Hozova, 2016).

Justification for classification or non-classification

Based on the results of an acute oral toxicity study, the test substance does not require classification for acute toxicity according to CLP (EC 1272/2008) criteria.