reaction products of diglycidyl ether bisphenol F (DGEBF) and oligomeric phenol diglycidyl ethers with acrylic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2010-06-08 - 2010-09-10

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study, GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

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

Test material

Test material information

Constituent 1

Reference substance name:

reaction products of diglycidyl ether bisphenol F (DGEBF) and oligomeric phenol diglycidyl ethers with acrylic acid

EC Number:

700-487-6

Molecular formula:

Not applicable.

IUPAC Name:

reaction products of diglycidyl ether bisphenol F (DGEBF) and oligomeric phenol diglycidyl ethers with acrylic acid

Details on test material:

- Name: Epoxy half acrylate

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

Six female Sprague Dawley rats (SPF Caw) originated from Elevage JANVIER (53940 Le Genest St Isle - France), were used after an acclimatization period of at least five days. At the beginning of the study, the animals of the treated group weighed between 187 and 202 g and were 8 weeks old.
Healthy female rats were housed by group of three in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid. Each cage contains sawdust bedding which was changed at least 2 times a week. Each cage was installed in conventional air conditioned animal husbandry. The temperature and relative humidity of the main test were controlled to remain within target ranges of 19 to 25°C and 30 to 70%, respectively.

The rate of air exchange was approximately fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (07.00 to 19.00) and twelve hours darkness.
Drinking water (tap-water from public distribution system) and foodstuff (M20-SDS) were supplied freely. Food was removed on D-l and then redistributed 4 hours after the test item administration. Microbiological and chemical analyses of the water were carried out once every six months by IPL, Santé, Environnement Durables - Atlantique.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

The animals of the treated group received an effective dose of 2000 mg/kg body of the test item:
The test item was administered by gavage under a volume of 1.70 mL/kg body weight (corresponding to 2 g/kg, according to the calculated density), using a suitable syringe graduated fitted with an oesophageal metal canula.

Doses:

2 g/kg, according to the calculated density

No. of animals per sex per dose:

6 female rats

Control animals:

no

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study.

Clinical signs:

No clinical signs related to the administration of the test item were observed.

Body weight:

The body weight evolution of the animals remained normal throughout the study.

Other findings:

The macroscopical examination of the animals at the end of the study did not reveal treatment related changes.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)

Conclusions:

In conclusion, the LD50 of the test item Epoxy half acrylate is higher than 2000 mg/kg body weight by oral route in the rat.

Executive summary:

The test item Epoxy half acrylate was administered to a group of 6 female Sprague Dawiey rats at the single dose of 2000 mg/kg body weight. The experimental protocol was established on the basis of the official method as defined in the OECD guideline No 423 dated December 17th, 2001 and the test method B.ltris of the Council regulation No 440/2008. No mortality occurred during the study. No clinical signs related to the administration of the test item were observed. The body weight evolution of the animals remained normal throughout the study. The macroscopical examination of the animals at the end of the study did not reveal treatment related changes. In conclusion, the LD50 of Epoxy half acrylate is higher than 2000 mg/kg body weight by oral route in the rat.