Registration Dossier

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

Constituent 1
Chemical structure
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:
There were no signs of reaction to treatment with RC9927.
Body weight:
All animals achived normal body weight gains during the 14-day observation period.
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.