Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 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: GLP compliance and OECD method
Qualifier:
according to guideline
Guideline:
other: OECD 401
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
other: rat, Tif:RAIF(SPF)
Vehicle:
other: 0.5%(w/v) carboxy methylcellulose in 0.1%w/v acqueous polysorbate
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
Male:2000 mg/kg bw; Number of animals:5; Number of deaths:0
Femaile: 2000 mg/kg bw; Number of animals:5; Number of deaths:0
Clinical signs:
other: Signs of toxicity related to dose levels: Only common symptoms such as piloerection, hunched posture and dyspnea were observed during the study
Gross pathology:
Effects on organs:
No deviation from normal morphology was observed at autopsy
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
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:
other: GLP compliance and OECD method
Qualifier:
according to guideline
Guideline:
other: OECD402
GLP compliance:
yes
Limit test:
yes
Species:
other: rat, Tif;RAIF(SPF)
Type of coverage:
semiocclusive
Vehicle:
other: 0.5(w/v)carboxymethylcellulose in 0.1%(w/v) acqueous polysorbate
Duration of exposure:
24 h
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
Male:2000 mg/kg bw;Number of animals:5; Number of deaths:0
Female:2000 mg/kg bw;Number of animals:5; Number of deaths:0
Clinical signs:
other: Signs of toxicity related to dose levels; Piloerection and hunched posture were observed during the study, as is normal with acute studies. All animals revovered within three days.
Gross pathology:
Effects on organs:
No deviation from normal morphology was observed at autopsy
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Justification for classification or non-classification