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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Subacute (28-day) study oral (gavage), rat (Wistar) m/f: NOAEL = 1000 mg/kg bw/day (nominal) (male/female) [EU Method B.7, GLP]

Key value for chemical safety assessment

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study obtained through inquiry process; SNIF file obtained from ECHA.
Qualifier:
according to guideline
Guideline:
EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
Deviations:
not specified
GLP compliance:
yes
Limit test:
no
Species:
rat
Strain:
Wistar
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
4 %
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
28 days
Frequency of treatment:
Dosing regime: 7 days/week
Remarks:
Doses / Concentrations:
Dose level (male & female): 0, 50, 200, 1000 mg/kg bw/day
Basis:

No. of animals per sex per dose:
Male: 10 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: 10 animals at 1000 mg/kg bw/day

Female: 10 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: 10 animals at 1000 mg/kg bw/day
Control animals:
yes, concurrent no treatment
Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
no effects observed
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
no effects observed
Clinical biochemistry findings:
no effects observed
Urinalysis findings:
not specified
Behaviour (functional findings):
no effects observed
Organ weight findings including organ / body weight ratios:
no effects observed
Gross pathological findings:
no effects observed
Histopathological findings: non-neoplastic:
not specified
Histopathological findings: neoplastic:
not specified
Key result
Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day (nominal)
Based on:
not specified
Sex:
male/female
Basis for effect level:
other: original NCD unit is mg/kg/day
Dose descriptor:
NOEL
Effect level:
1 000 mg/kg bw/day (nominal)
Based on:
not specified
Sex:
male/female
Basis for effect level:
other: original NCD unit is mg/kg/day
Critical effects observed:
not specified
Conclusions:
NOAEL = 1000 mg/kg bw/day;
no significant effects were noted
Executive summary:

The oral repeated dose toxicity of the test substance has been determined in a subacute GLP study with rats (8 groups of 5 or 10 animals each; 4 groups of males and 4 groups of females) according to EU Method B.7 (28-days, 7 days a week, of oral gavage exposure at doses of 0, 50, 200 and 1000 mg/kg bw/d). There weren't any observed effects, no deaths were observed; a NOAEL (and NOEL) of 1000 mg/kg bw/day (nominal) have been determined.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
The data has been extracted from ECHA databases. The files were first migrated from the SNIF (Structured Notification Interchange Format) format (used under Directive 67/548/EEC) into the IUCLID 5 format (used under the REACH Regulation) and represent all of the information that ECHA currently holds on this endpoint, which were submitted in the framework of a notification at least 12 years previously (as per Article 25(3)) for the substance with the same EC number for which you inquired.

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

The oral repeated dose toxicity of the test substance has been determined in a subacute GLP study with rats (8 groups of 5 or 10 animals each; 4 groups of males and 4 groups of females) according to EU Method B.7 (28-days, 7 days a week, of oral gavage exposure at doses of 0, 50, 200 and 1000 mg/kg bw/d). There weren't any observed effects, no deaths were observed; a NOAEL and a NOEL of 1000 mg/kg bw/day (nominal) have been determined.


Justification for classification or non-classification

Repeated dose toxicity: oral

The test material does not meet the criteria for classification and will not require labelling in accordance with European Regulation (EC) No. 1272/2008.