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Description of key information

The NOAEL was 1000 mg/kg/bw and it will be used for the risk assessment.

Key value for chemical safety assessment

Toxic effect type:
dose-dependent

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records
Reference
Endpoint:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1989-06-02
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Justification for type of information:
The structure of the read-across substance is the para form of the CJ301 without the meta form. However, this difference does not influence the toxicity of the CJ301. CJ301 contains Li/Na salt form and the read-across substances contains only Na salt. This will not lead to difference on the toxicity results.
Qualifier:
according to
Guideline:
OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents)
Version / remarks:
1981
Qualifier:
according to
Guideline:
EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
GLP compliance:
yes
Species:
rat
Strain:
Wistar
Remarks:
KFM-Han SPF
Sex:
male/female
Route of administration:
oral: unspecified
Vehicle:
other: dest. Wasser + 4 % CMC-Na-Salz
No. of animals per sex per dose:
Male: 5 animals at 0 mg/kg bw/day
Male: 5 animals at 50 mg/kg bw/day
Male: 5 animals at 200 mg/kg bw/day
Male: 5 animals at 1000 mg/kg bw/day
Female: 5 animals at 0 mg/kg bw/day
Female: 5 animals at 50 mg/kg bw/day
Female: 5 animals at 200 mg/kg bw/day
Female: 5 animals at 1000 mg/kg bw/da
Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day (nominal)
Based on:
test mat.
Basis for effect level:
mortality
Critical effects observed:
no

No mortalities occurred.

Yellow colouration of the skin in the neck and back region and of the mucous membrane of some animals from the medium and high-dose groups was a substance-related change. However, it was interpreted as non-toxic. The comparison between all of the examined parameters did not reveal any significant differences between the controls and the treatment groups.

Conclusions:
The NOAEL of the test material was 1000 mg/kg/day.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification