Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
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 402 (Acute Dermal Toxicity)
Principles of method if other than guideline:
Groups of 5 male and 5 female rats were administered a single dose of 2 ml of the test material per kg bw to the shaved intact site on the back for 24 hours. The animals were observed for mortality, clinical signs and body weight for 14 days. A complete necropsy was performed on each rabbit.
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:
bis(2-ethylhexyl) tetrabromophthalate
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:
rabbit
Strain:
New Zealand White
Sex:
male/female

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24 hours
Doses:
2 ml/kg bw (= 3.09 g/kg bw)
No. of animals per sex per dose:
5 male and 5 female animals/dose
Control animals:
not specified

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mL/kg bw
Based on:
test mat.
Remarks on result:
other: 2 ml/kg bw (= 3.09 g/kg bw)
Mortality:
No animal died during the course of the study.
Clinical signs:
There were no local or systemic signs of reaction to treatment, following percutaneous treatment with RC9927.
Body weight:
All animals achived normal body weight gains during the 14-day observation period.
Gross pathology:
Necropsy on Day 15 revealed dark thyroids, thymus, lungs and salivary glands, petechiae of the thymus and/or abnormal gastrointestinal contents in the majority of animals. However, these are common findings for rabbits at this laboratory and were not considered to be related to treatment with the testmaterial.

Any other information on results incl. tables

No animal died during the course of the study. There were no local or systemic signs of reaction to treatment, following percutaneous treatment with RC9927. All animals achived normal body weight gains during the 14-day observation period. Necropsy on Day 15 revealed dark thyroids, thymus, lungs and salivary glands, petechiae of the thymus and/or abnormal gastrointestinal contents in the majority of animals. However, these are common findings for rabbits at this laboratory and were not considered to be related to treatment with the testmaterial. Pale staining around the nares or occasional areas of exfoliation at the dermal application site were also recorded for single animals.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Discriminating dose of the test substance was greater than 2 ml/kg (= 3.09 g/kg bw).
Executive summary:

Groups of 5 male and 5 female rats were administered a single dose of 2 ml of the test material per kg bw to the shaved intact site on the back for 24 hours. The animals were observed for mortality, clinical signs and body weight for 14 days. A complete necropsy was performed on each rabbit.

No animal died during the course of the study. There were no local or systemic signs of reaction to treatment, following percutaneous treatment with RC9927. All animals achived normal body weight gains during the 14-day observation period. Necropsy on Day 15 revealed dark thyroids, thymus, lungs and salivary glands, petechiae of the thymus and/or abnormal gastrointestinal contents in the majority of animals. However, these are common findings for rabbits at this laboratory and were not considered to be related to treatment with the testmaterial. Pale staining around the nares or occasional areas of exfoliation at the dermal application site were also recorded for single animals.

Under the conditions of this study, the acute percutaneous median lethal dosage (LD50) of the test substance was greater than 2 ml/kg (= 3.09 g/kg bw).