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Administrative data

Description of key information

For the oral and dermal route, acute toxicity studies are available. These studies were designed as limit dose studies and no toxicity was noted.

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study used for notification under 67/548. Original study report not available.
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
not specified
Details on test animals or test system and environmental conditions:
no data
Route of administration:
oral: unspecified
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
no data
Doses:
no data
No. of animals per sex per dose:
5
Details on study design:
no data
Statistics:
no data
Preliminary study:
no data
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
no mortality occured
Clinical signs:
Signs of toxicity related to dose levels:
after application tousled fur was observed for the rest of the day.
no other signs of toxicity were observed throughout the study.
Gross pathology:
no gross lessions were observed.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The limit test for oral toxicity in the rat did not show any toxic effects up to a dose of 5000 mg/kg bw.
Executive summary:

The study was conducted according to Guideline EU B.1 and was designed as a limit test.

A single dose of 5000 mg/kg bw of the substance in CMC (carboxymethyl cellulose) was administered to rats by the oral route.

After the application, the animals showed tousled fur for the rest of the day. No signs of toxicity were observed for the duration of the study.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
5 000 mg/kg bw
Quality of whole database:
one study available

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study used for notification under 67/548. Original study report not available.
Reason / purpose for cross-reference:
reference to same study
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
not specified
Details on test animals or test system and environmental conditions:
no data
Type of coverage:
semiocclusive
Vehicle:
water
Details on dermal exposure:
no data
Duration of exposure:
24 h
Doses:
no data
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
no data
Statistics:
no data
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
mortality was not observed during the study period
Clinical signs:
no signs of toxicity observed.
Gross pathology:
no gross lessions were observed.
Other findings:
Signs of toxicity (local):
no signs of dermal toxicology at application sites observed.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The limit test for dermal toxicity in the rat did not show any toxic effects up to a dose of 2000 mg/kg bw.
Executive summary:

The study was conducted according to Guideline EU B.3 and was designed as a limit test.

A single dose of 2000 mg/kg bw of the substance was administered to rats by the dermal route.

No signs of toxicity were observed for the duration of the study

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
one study available

Additional information

Justification for selection of acute toxicity – oral endpoint
One study available, used for former regulatory purposes.

Justification for selection of acute toxicity – dermal endpoint
One study available, used for former regulatory purposes.

Justification for classification or non-classification

The study results are conclusive but not sufficient for classification.