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Description of key information

Key study: Test method B.1tris. GLP study. The LD50 resulted to be > 2000 mg/kg bw. 

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:
other: Test method according to 96/54/EG, B.1 tris (Acute toxic class method). GLP study.
Qualifier:
according to guideline
Guideline:
other: 96/54/EG, B.1tris (Akute-toxische-Klassen-Methode)
Deviations:
not specified
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
other: Wistar Crl:(WI)BR
Sex:
male/female
Route of administration:
oral: unspecified
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
1% aqueous carboxymethycellulose.
Details on oral exposure:
VEHICLE: 1% aqueous carboxymethyl cellulose.
Doses:
2000 mg/kg
No. of animals per sex per dose:
3 animals per sexe per dose
Control animals:
not specified
Details on study design:
- Other examinations performed: clinical signs, gross pathology.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
Male: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 0
Clinical signs:
2 - 4 h after application of the substance all females showed a hunched posture. No other toxicologic effects were observed.
Gross pathology:
No effects were observed.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No mortalities, significant clinical signs or gross pathology changes were observed after the exposure of male and female rats to 2000 mg/kg test substance in 1% aqueous carboxymethyl cellulose.
Executive summary:

An oral acute study was performed in male and female rats under GLP conditions according the the guideline 96/54/EG, B.1tris (Acute toxic class method). 3 rats per sexe were exposed to a single administration of the test substance at concentration of 2000 mg/kg in 1% aqueous carboxymethyl cellulose. There were no mortalities, the only clinical sign was that 2 - 4 hours after the application of the substance all females showed a hunched posture. No effects in gross pathology were observed.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
The key study is GLP compliant is of high quality (Klimisch score = 1).

Additional information

Key study: An oral acute study was performed in male and female rats under GLP conditions according the the guideline 96/54/EG, B.1tris (Acute toxic class method). The LD50 resulted to be > 2000 mg/kg bw.


Justification for selection of acute toxicity – oral endpoint
Only one study available.

Justification for classification or non-classification

Based on the available data (LD50 in rats >2000 mg/kg bw) the substance is not classified according to CLP Regulation (EC) No 1272/2008.