Fatty acids, tall-oil, polymers with glycidyl neodecanoate

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 July 16, 2015 to July 31, 2015

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

Qualifier:

according to guideline

Guideline:

other: Guidance document on acute oral toxicity testing, OECD series on testing and assessment no 24, 2001

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: Guidance document on the recognition, assessment and use of clinical signs as human endpoints for experimental animals used in safety evaluation. Environmental health and safety publications series on testing and assessment no 19, 2000.

Deviations:

no

GLP compliance:

yes (incl. QA statement)

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:

TEST ANIMALS
- Source: Velaz Prague, Czech Republic.
- Body weight at study initiation: 175±15 g.
- Fasting period before study: 16 h.
- Housing: The animals were housed in plastic cages suspended on stainless steel racks, up to 3 animals per cage in a room equipped with central air conditioning.
- Diet: A laboratory food Altromin (Altromin Speziallfutter GmbH, Germany) was offered in recommended doses each day approximately at the same time.
- Water: Tap water ad libitum.
- Acclimation period: 5 d.

ENVIRONMENTAL CONDITIONS
- Temperature: 22±2°C.
- Humidity: 55±10%.
- Photoperiod: 12 h light and 12 h dark cycle.

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

- Dose preparation: The required amount of the test substance (according to body weight) was mixed with vehicle (olive oil) shortly before administration.
- Dose 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 weighed and the test substance administered. After the test substance had been administered, food was withheld for further 3-4 h.

Doses:

2,000 mg/kg bw

No. of animals per sex per dose:

6 females

Details on study design:

- Duration of observation period following administration: 14 d.
- Frequency of observations: The onset, type and duration of all symptoms of poisoning, and the time of death, were noted 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.
- Body weights: Individual weights of animals were determined shortly before the test substance was administered and at weekly thereafter.
- 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.
- Necropsy of survivors performed: 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:

No mortality was observed in the treated animals.

Clinical signs:

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

Gross pathology:

During necropsy, no macroscopic changes were noticed.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The oral LD50 of the test substancein rats was determined to be >2000 mg/kg bw.

Executive summary:

A study was conducted to assess the acute toxicity of the test substance to Wistar rats according to OECD Guideline 423, in compliance with GLP. The test substance was administered by gavage to 6 fasted females at the limit dose of 2000 mg/kg bw. Animals were observed individually immediately after dosing, at 0.5, 1, 2 and 4 h, then daily for 14 d. Bodyweights were recorded before treatment, then 7 and 14 d after treatment. All animals were sacrificed at the end of the study and subjected to gross examination. There was no mortality and no bodyweight loss between one and two week after administration of the test substance. No significant signs of toxicity were observed during the first 4 h or in the course of the 14 d observation period. At necropsy, no macroscopic changes were noted. Based on the results of the study, the oral LD50 of the test substance was determined to be >2000 mg/kg bw (Hozova, 2015).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

High quality

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:

the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size

other:

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:

other:

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

A study was conducted to assess the acute toxicity of the test substance to Wistar rats according to OECD Guideline 423, in compliance with GLP. The test substance was administered by gavage to 6 fasted females at the limit dose of 2000 mg/kg bw. Animals were observed individually immediately after dosing, at 0.5, 1, 2 and 4 h, then daily for 14 d. Bodyweights were recorded before treatment, then 7 and 14 d after treatment. All animals were sacrificed at the end of the study and subjected to gross examination. There was no mortality and no bodyweight loss between one and two week after administration of the test substance. No significant signs of toxicity were observed during the first 4 h or in the course of the 14 d observation period. At necropsy, no macroscopic changes were noted. Based on the results of the study, the oral LD50 of the test substance was determined to be >2000 mg/kg bw (Hozova, 2015).

Justification for classification or non-classification

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