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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
sub-chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Cross-reference
Reason / purpose for cross-reference:
other: read-across target
Reference
Endpoint:
sub-chronic toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted on read-across material
Reason / purpose for cross-reference:
read-across source
Dose descriptor:
NOAEL
Effect level:
14 000 ppm
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: No adverse treatment-related effects were noted.
Critical effects observed:
no

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.26 (Sub-Chronic Oral Toxicity Test: Repeated Dose 90-Day Oral Toxicity Study in Rodents)
Deviations:
no
Limit test:
no

Test material

Constituent 1
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: feed

Results and discussion

Results of examinations

Details on results:
ANALYSIS OF TEST SUBSTANCE IN VEHICLE
Homogeneity and stability of the test material in the diet were checked prior to study start. These analytical investigations showed the test material to be homogeneously distributed and stable in the concentration range used beyond the period of use. Analyses during the study verified that the test material content agreed with the target concentrations and that the test material was homogeneously distributed in the diet within the defined limits (Table 1).

Effect levels

Dose descriptor:
NOAEL
Effect level:
14 000 ppm
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: No adverse treatment-related effects were noted.

Target system / organ toxicity

Critical effects observed:
no

Any other information on results incl. tables

For result tables 1 - 16 see attached document.

Applicant's summary and conclusion