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Administrative data

Description of key information

A valid acute oral study according OECD 401 (limit test) and dermal toxicity study according OECD 402 is available. No acute inhalation study is on hand.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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
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
Species:
rat
Strain:
other: Charles River CD
Sex:
male/female
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
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.

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.

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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
5 000 mg/kg bw
Quality of whole database:
The materials/methods and results are described in detail und are sufficient for evaluation

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
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
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
Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
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
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.

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.

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).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw
Quality of whole database:
The materials/methods and results are described in detail und are sufficient for evaluation

Additional information

In the acute oral toxicity study 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 relevant signs of reaction to treatment with bis(2-ethylhexyl) tetrabromophthalate.

In the acute dermal toxicity study groups of 5 male and 5 female rats were administered a single dose of 2 ml (3.09 mg/kg bw) 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 relevant systemic signs of reaction to treatment, following percutaneous treatment with bis(2-ethylhexyl) tetrabromophthalate.


Justification for classification or non-classification

In the acute oral toxicity study a LD50 > 5000 mg/kg bw and in the acute dermal toxicity study a LD50 > 2000 mg/kg bw was found.

According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.