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

Acute Toxicity: oral

Administrative data

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

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

Test material

Test material information

Constituent 1

Reference substance name:

Reaction product of oxiran-2-ylmethyl 2,2,3,5-tetramethylhexanoate with linseed oil fatty acids (including majorly linolenic acid, linoleic acid and oleic acid) (1:1)

Molecular formula:

Not applicable (UVCB constituent)

IUPAC Name:

Reaction product of oxiran-2-ylmethyl 2,2,3,5-tetramethylhexanoate with linseed oil fatty acids (including majorly linolenic acid, linoleic acid and oleic acid) (1:1)

Constituent 2

Reference substance name:

Reaction product of 4,4'-Methylendiphenyldiglycidylether (BADGE) with linseed oil fatty acids (including majorly linolenic acid, linoleic acid and oleic acid) (1:2)

Molecular formula:

Not applicable (UVCB constituent)

IUPAC Name:

Reaction product of 4,4'-Methylendiphenyldiglycidylether (BADGE) with linseed oil fatty acids (including majorly linolenic acid, linoleic acid and oleic acid) (1:2)

Constituent 3

Reference substance name:

Reaction product of 4,4'-Methylendiphenyldiglycidylether (BADGE) with linseed oil fatty acids (including majorly linolenic acid, linoleic acid and oleic acid) (1:1)

Molecular formula:

Not applicable (UVCB substance)

IUPAC Name:

Reaction product of 4,4'-Methylendiphenyldiglycidylether (BADGE) with linseed oil fatty acids (including majorly linolenic acid, linoleic acid and oleic acid) (1:1)

Constituent 4

Reference substance name:

Reaction product of 4,4'-Methylendiphenyldiglycidylether (BADGE) with linseed oil fatty acids (including majorly linolenic acid, linoleic acid and oleic acid) (1:3)

Molecular formula:

Not applicable (UVCB substance)

IUPAC Name:

Reaction product of 4,4'-Methylendiphenyldiglycidylether (BADGE) with linseed oil fatty acids (including majorly linolenic acid, linoleic acid and oleic acid) (1:3)

Constituent 5

Reference substance name:

High Mw components based on linseed oil fatty acids

Molecular formula:

Not applicable (UVCB substance)

IUPAC Name:

High Mw components based on linseed oil fatty acids

Constituent 6

Reference substance name:

Sum of unassigned components

Molecular formula:

Not applicable (UVCB substance)

IUPAC Name:

Sum of unassigned components

Test material form:

liquid

Details on test material:

UVCB

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

Test animals

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

Administration / exposure

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

Results and discussion

Effect levels

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

Applicant's summary and conclusion

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).