Fatty acids, linseed-oil, reaction products with bisphenol A-epichlorohydrin polymer and glycidyl neodecanoate

Endpoint summary

Description of key information

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

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 March 15, 2016 to March 30, 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

Specific details on test material used for the study:

Lot Number: #210162718
Reaction products of linseed-oil fatty acids, 4,4'-methylendiphenyldiglycidylether with neodecanoic fatty acid, oxiranylmethylester
Purity 100% as per definition of UVCB
Appearance: brown liquid

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:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

not determinable due to absence of adverse toxic effects

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:

No changes were observed

Interpretation of results:

other: CLP criteria not met

Remarks:

does not require classification

Conclusions:

Under the study conditions, the LD50 of the test substance was greater than 2000 mg/kg, 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. Six females were administered the test substance at a concentration of 2000 mg/kg bw by gavage. 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 days. 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. All test animals were subjected to gross necropsy. All gross pathological changes were recorded for each animal. All 6/6 females survived the limit dose of 2000 mg/kg. Animals lived through observation period without signs of intoxication. Neither change of health nor negative reactions were registered. The body weights of all animals were increasing during the study. No body weight losses were observed between first and second week after administration. No changes were observed at necropsy. Under the study conditions, the LD50 of the test substance was greater than 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

Quality of whole database:

Guideline compliant study

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

other justification

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

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:

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

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. Six females were administered the test substance at a concentration of 2000 mg/kg bw by gavage. Animals were observed individually immediately after the administration of the test substance and then 0.5, 1, 2, and 4 hours later. Then each animal was inspected daily for the next 14 days. 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. All test animals were subjected to gross necropsy. All gross pathological changes were recorded for each animal. All 6/6 females survived the limit dose of 2000 mg/kg. Animals lived through observation period without signs of intoxication. Neither change of health nor negative reactions were registered. The body weights of all animals were increasing during the study. No body weight losses were observed between first and second week after administration. No changes were observed at necropsy. Under the study conditions, the LD50 of the test substance was greater than 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 need to be classified for this endpoint according to CLP criteria (EC 1272/2008).