Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Endpoint:
repeated dose toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Report date:
1988
Reference Type:
study report
Title:
Unnamed
Report date:
1988
Reference Type:
study report
Title:
Unnamed

Materials and methods

GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Automatically generated during migration to IUCLID 6, no data available
IUPAC Name:
Automatically generated during migration to IUCLID 6, no data available

Test animals

Species:
other: dogs, mice

Results and discussion

Effect levels

open allclose all
Dose descriptor:
NOAEL
Effect level:
10 mg/kg bw/day (actual dose received)
Basis for effect level:
other: Beagle dogs (2 males and 2 females in dose groups of 0, 10, 40, and 160 mg/kg bw), 4 week daily dosing with Bay u 3405 capsules
Dose descriptor:
NOAEL
Effect level:
180 mg/kg bw/day (actual dose received)
Basis for effect level:
other: mice (10 males and 10 females in dose groups of 0, 5, 30, 180, and 300 mg/kg bw), 78 days daily dosing with Bay u 3405 via gavage

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion