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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

28 d toxicity study with rats: NOAEL: 1000 mg/kg bw/ day
90 d toxicity study with rats: NOAEL: 406 mg/kg bw/ day

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records
Reference
Endpoint:
repeated dose toxicity: oral
Remarks:
other: no data
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The information of this endpoint has been provided by ECHA as a result of an inquiry, thus the full access to data in the report is not accessible to the registrant. That´s why the reliability is estimated to be at level 2.
Qualifier:
according to guideline
Guideline:
other: OECD Guideline 408 (1981) EEC Directive 87/302 (1987) - Annex V Part B
GLP compliance:
yes
Limit test:
no
Species:
other: Sprague-Dawley rat
Sex:
male/female
Route of administration:
oral: unspecified
Vehicle:
other: /
Details on oral exposure:
Method of administration:
dietary admixture.
Duration of treatment / exposure:
Test duration: 90 days
Frequency of treatment:
Dosing regime: 7 days/week
No. of animals per sex per dose:
Male: 30 animals at 0 mg/kg bw/day
Male: 20 animals at 123.1 mg/kg bw/day
Male: 20 animals at 406.4 mg/kg bw/day
Male: 20 animals at 1261.3 mg/kg bw/day
Female: 30 animals at 0 mg/kg bw/day
Female: 20 animals at 135.7 mg/kg bw/day
Female: 20 animals at 478.5 mg/kg bw/day
Female: 20 animals at 1479.2 mg/kg bw/day
Details on results:
Clinical observations:
No mortality and no treatment-related clinical signs were
noted.
A decreased body weight gain was noted for group 3
males
(not significant) and group 4 males and females
(statistically significant).
Laboratory findings:
A very slight increase of blood urea nitrogen was noted in
group 4 (not significant when compared to controls). This
effect was reversible after 4 weeks without treatment.
Effects in organs:
No histopathological finding was considered to be
treatment related.
Dose descriptor:
NOAEL
Effect level:
406.4 mg/kg bw/day (nominal)
Basis for effect level:
other: original NCD unit is mg/kg/day.
Dose descriptor:
NOEL
Effect level:
123.1 mg/kg bw/day (nominal)
Basis for effect level:
other: original NCD unit is mg/kg/day.
Critical effects observed:
not specified
Conclusions:
Classified as: not classified
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
406 mg/kg bw/day
Study duration:
subchronic
Species:
rat
Quality of whole database:
2 reliable studies (28 and 90 d) available

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 selection of repeated dose toxicity via oral route - systemic effects endpoint:
2 reliable studies (28 and 90 d)

Justification for classification or non-classification

Based on the results of two reliable repeated dose toxicity studies with rats (28 and 90 d), there were no treatment related effects that would fulfil any criteria for classification and labelling according to the criteria laid out in Regulation (EC) No.: 1272/2008 (especially "3.9. Specific target organ toxicity — repeated exposure").