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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
screening for reproductive / developmental toxicity
Remarks:
based on test type (migrated information)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2010
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Direct yellow 169

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on exposure:
males: 2 weeks premating, ca. 2 weeks mating, ca. 1 week post mating
females: 2 weeks premating, ca. 2 weeks mating,gestation period and lactation (4 days)
Details on mating procedure:
F0 animals were mated 13 days after the beginning of treatment to produce litter (F1
generation pups). Mating pairs were from the same test group. Mating was discontinued as
soon as sperm was detected in the vaginal smear.
Analytical verification of doses or concentrations:
yes
Details on analytical verification of doses or concentrations:
stability of the test substance preparations over 7 days and concentrations of preparations at the start and towards the end of the treatment period
Frequency of treatment:
once daily
Details on study schedule:
according to guideline OECD 421
Doses / concentrations
Remarks:
Doses / Concentrations:
50, 200, 1000 mg/kg/day
Basis:
nominal conc.
No. of animals per sex per dose:
10
Control animals:
yes, concurrent vehicle

Results and discussion

Results: P0 (first parental generation)

Details on results (P0)

The following test-substance related, relevant findings were noted:
F0 parental animals
• Clinical Examinations: No treatment-related findings were observed.
• Pathology: No treatment-related findings were observed.

Effect levels (P0)

Dose descriptor:
NOAEL
Effect level:
>= 1 000 mg/kg bw/day
Sex:
male/female
Remarks on result:
other: Generation: P and F1 (migrated information)

Results: F1 generation

Details on results (F1)

F1 pups: No treatment-related findings were observed.

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion