Bis(2-ethylhexyl) tetrabromophthalate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

Groups of 5 male and 5 female rats were administered by gavage a single oral dose of 5000 mg/kg bw of the test material. Animals were observed for mortality, clinical signs and body weight for 14 days. A complete necropsy was performed on each rat.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Bis(2-ethylhexyl) tetrabromophthalate

EC Number:

247-426-5

EC Name:

Bis(2-ethylhexyl) tetrabromophthalate

Cas Number:

26040-51-7

Molecular formula:

C24H34Br4O4

IUPAC Name:

1,2-bis(2-ethylhexyl) 3,4,5,6-tetrabromobenzene-1,2-dicarboxylate

Test material form:

liquid

Details on test material:

RC 9927 (batch 6159-199-3), also identified as FR-45B, a slightly turbid, viscous pale yellow liquid received from Pennwalt Corporation on 1st September 1986.

Test animals

Species:

rat

Strain:

other: Charles River CD

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

maize oil

Remarks:

50% v/v solution

Doses:

1 dose of 5000 mg/kg bw

No. of animals per sex per dose:

5 male and 5 female rats/dose

Control animals:

no

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No animals died during the course of the study.

Clinical signs:

other: There were no signs of reaction to treatment with RC9927.

Gross pathology:

Necropsy findings on Day 15 were confined to single observations of occasional dark areas on the thymus and fluid distensions of the uterus. Neither of these lesions were considered to reflect an effect of treatment with RC9927.

Any other information on results incl. tables

No animals died during the course of the study. There were no signs of reaction to treatment with RC9927. All animals achived normal body weight gains during the 14-day observation period. Necropsy findings on Day 15 were confined to single observations of occasional dark areas on the thymus and fluid distensions of the uterus. Neither of these lesions were considered to reflect an effect of treatment with RC9927.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Discriminating dose > 5000 mg/kg bw.

Executive summary:

Groups of 5 male and 5 female rats were administered by gavage a single oral dose of 5000 mg/kg bw of the test material. Animals were observed for mortality, clinical signs and body weight for 14 days. A complete necropsy was performed on each rat.

No animals died during the course of the study. There were no signs of reaction to treatment with RC9927. All animals achived normal body weight gains during the 14-day observation period. No relevant necropsy findings on Day 15 were reported.

Under the conditions of this study, the acute oral medium lethal doseage (LD50) of the test material RC 9927 was greater than 5000 mg/kg bw.