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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:
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:
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
2 000 mg/kg bw

Acute toxicity: via inhalation route

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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:
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:
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
2 000 mg/kg bw

Additional information

Justification for classification or non-classification