Registration Dossier

Diss Factsheets

Toxicological information

Endpoint summary

Currently viewing:

Administrative data

Description of key information

Toxicity(Oral):LD 50 > 5000 mg/kg bw (OECD 401, GLP)


Toxicity(Dermal):LD 50 > 2000 mg/kg bw (OECD 402, GLP)

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)
Qualifier:
according to guideline
Guideline:
other: OECD 401 (1981)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Route of administration:
oral: unspecified
Vehicle:
other: 0.5% aqueous carboxymethylcellulose
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
Male : 5000mg/kg bw; number of animals : 5 ; number of deaths : 0
Female : 5000mg/kg bw; number of animals : 5 number of deaths : 0
Clinical signs:
other:
Gross pathology:
Effects on organs : No conspicuous findings
Interpretation of results:
other: not classified Migrated information Criteria used for interpretation of results: EU
Conclusions:
Not classified
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
> 5 000 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:
the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
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)
Qualifier:
according to guideline
Guideline:
other: OECD 402 (1981)
GLP compliance:
yes
Limit test:
yes
Species:
rat
Strain:
other: common species
Sex:
male/female
Type of coverage:
semiocclusive
Vehicle:
olive oil
Duration of exposure:
24 h
Control animals:
not specified
Key result
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:
Gross pathology:
Effects on organs : No conspicuous findings
Other findings:
Signs of toxicity (local) : No conspicuous findings
Interpretation of results:
other: not classified Migrated information Criteria used for interpretation of results: EU
Conclusions:
not classified
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