Reaction products of 2,2'-[(1-methylethylidene)bis(4,1-phenyleneoxymethylene)]bisoxirane with maleic anhydride and methacrylic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

8 February 2010 to 22 March 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study with a minor protocol deviation and compliant with GLP. The study integrity was not affected by the deviations.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

yes

Remarks:

deviations from the minimum level of relative humidity occurred

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

yes

Remarks:

deviations from the minimum level of relative humidity occurred

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

deviations from the minimum level of relative humidity occurred

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: JMAFF, 12 Nousan, Notification No 8147, November 2000, including the most recent partial revisions

Deviations:

yes

Remarks:

deviations from the minimum level of relative humidity occurred

GLP compliance:

yes

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

Reaction products of 2,2'-[(1-methylethylidene)bis(4,1-phenyleneoxymethylene)]bisoxirane with maleic anhydride and methacrylic acid

EC Number:

701-427-1

Cas Number:

36425-16-8

Molecular formula:

Not applicable: UVCB

IUPAC Name:

Reaction products of 2,2'-[(1-methylethylidene)bis(4,1-phenyleneoxymethylene)]bisoxirane with maleic anhydride and methacrylic acid

Details on test material:

Substance 3, NLP 500-090-6 (old name of EC 701-427-1)

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

propylene glycol

Doses:

2000 mg/kg

No. of animals per sex per dose:

3 animals per dose group

Control animals:

no

Details on study design:

single dosage on Day 1.
Observations until day 15.

Statistics:

No statistical analysis was performed (The method used is not intended to allow the calculation of a precise LD50 value).

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

discriminating dose

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: According the OECD guideline 423 the LD50 cut-off value is considered to larger than 5000 mg/kg bw

Mortality:

no mortality occurred

Clinical signs:

other: piloerection was noted in three animals on Day 1. In addition one animal showed hunched posture on Day 1 and 2.

Gross pathology:

No abnormalities were found at macroscopic post mortem examination of the animals.

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

The oral LD50 value of Modified Small Vinyl Ester in Wistar rats was established to exceed 2000 mg/kg bw.
According to the OECD 423 test guideline, the LD50 cut-off value was considered to exceed 5000 mg/kg bw.

Executive summary:

Modified Small Vinyl Ester was tested for acute oral toxicity using the acute toxic class method (OECD guideline 423) with a minor protocol deviation and compliant with GLP. The study integrity was not affected by the deviations.

The oral LD50 value of Modified Small Vinyl Ester in Wistar rats was established to exceed 2000 mg/kg bw.

According to the OECD test guideline, the LD50 cut-off value was considered to exceed 5000 mg/kg bw.