Hexane, 1,6-diisocyanato-, homopolymer, 2-hydroxyethyl acrylate- and propylene glycol monoacrylate-blocked

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 August 16, 2016 to August 31, 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)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

Species: Wistar rats;
Source: Velaz, Czech Republic;
Number and Sex of Animals: 6 females;
Age: 8-12 weeks; female animals were non-pregnant and nulliparous.
The animals were acclimated under the conditions identical to the conditions during the experiment 5 d prior to the start of treatment.
Housing Condition: The animals were housed in plastic cages suspended on stainless steel racks, up to 3 animals per cage in a room equipped with central airconditioning.
The average room temperature was maintained within the range of 21.6 ± 0.4° C, relative humidity within 55.4 ± 4.4%. The light regimen was set to a 12 h light /12 h dark cycle.
Diet: A laboratory food ssniff (Spezialdiäten GmbH, Germany) was offered in recommended doses each day approximately at the same time.
Water: The animals received tap water

Route of administration:

oral: feed

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:

A limit dose of 2000 mg/kg body weight was used as a starting dose. One group of 3 females was dosed. Test substance-related mortality was not observed during 24 h and therefore in a second step another 3 females were treated at the same dose.

No. of animals per sex per dose:

6 females

Control animals:

no

Details on study design:

Clinical Observation: Animals were observed individually immediately after the administration of the test substance and then 0.5, 1, 2, and 4 h later. Then each animal was inspected daily for the next 14 d. Observations included changes in skin and fur, eyes and mucous membranes, and also respiratory, circulatory, autonomic and central nervous systems, and somatomotor activity and behaviour pattern. Attention was directed to observations of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.

Body Weight: Individual weights of animals were determined shortly before the test substance was administered and weekly thereafter. Weight differences after first and second weeks after administration were calculated and recorded.

Necropsy: All test animals were subjected to gross necropsy. Full, detailed gross necropsy included careful examination of external surface of the body, all orifices, and cranial, thoracic and abdominal cavities and their contents. All gross pathological changes were recorded for each animal.

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

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

Clinical signs:

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

Gross pathology:

All animals were necropsied. During necropsy, no macroscopic findings were noticed. No pathological changes were found in the stomach.

Interpretation of results:

GHS criteria not met

Conclusions:

Under the study condtions, the acute oral LD50 of the substance in rats was >2000 mg/kg bw.

Executive summary:

A study was conducted to determine the acute oral toxicity of the substance according to OECD Guideline 423 (acute toxic class method), in compliance with GLP. Available information indicated that the test substance is likely to be non-toxic, therefore, a limit dose of 2000 mg/kg bw was used as a starting dose. Two groups of 3 females were dosed (by gavage). All 6 females survived the limit dose. The test substance did not cause any mortality, evident signs of toxicity or body weight loss during the 14-day observation period. Under the study conditions, the acute oral LD50 of the substance in rats was >2000 mg/kg bw (Hozova, 2016).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

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:

A study was conducted to determine the acute oral toxicity of the substance according to OECD Guideline 423 (acute toxic class method), in compliance with GLP. Available information indicated that the test substance is likely to be non-toxic, therefore, a limit dose of 2000 mg/kg bw was used as a starting dose. Two groups of 3 females were dosed (by gavage). All 6 females survived the limit dose. The test substance did not cause any mortality, evident signs of toxicity or body weight loss during the 14-day observation period. Under the study conditions, the acute oral LD50 of the substance in rats was >2000 mg/kg bw (Hozova, 2016).

Justification for classification or non-classification

Based on the results of an acute oral toxicity study, the substance does not need to be classified according to the criteria of EU CLP (EC) 1272/2008.