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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Authorative secondary source with limited information provided. Original study report was not available.

Data source

Referenceopen allclose all

Reference Type:
secondary source
Title:
Unnamed
Year:
2005
Report date:
2005
Reference Type:
other: study report as cited in secondary source
Title:
Unnamed
Year:
1989

Materials and methods

Principles of method if other than guideline:
Secondary literature source no data about the method was available.
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
Reference substance 001

Test animals

Species:
dog
Sex:
not specified

Administration / exposure

Route of administration:
oral: feed
Vehicle:
not specified
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
52 -week
Doses / concentrations
Remarks:
Doses / Concentrations:

Basis:

Positive control:
not applicable

Results and discussion

Results of examinations

Details on results:
Considering liver enzymes, liver weights and liver lesions at a LOAEL of 15 mg/kg/day, the NOAEL is 3 mg/kg/day.

Effect levels

open allclose all
Dose descriptor:
NOAEL
Effect level:
3 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
not specified
Dose descriptor:
LOAEL
Effect level:
15 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
not specified

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion