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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

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:
other: 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.