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Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted on the free acid form of the CAS 16090-02-1.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998
Reference Type:
secondary source
Title:
Substance: Fluorescent Brightener FWA-1 (CAS 16090-02-1).
Author:
HERA
Year:
2004
Bibliographic source:
HERA - Human & Environmental Risk Assessment on ingredients of European household cleaning products. - Draft - Version October 2004

Materials and methods

Principles of method if other than guideline:
Pilot developmental toxicity study in rabbits.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Free acid form of the cas 16090-02-1

Test animals

Species:
rabbit
Strain:
New Zealand White

Administration / exposure

Route of administration:
oral: gavage
Duration of treatment / exposure:
Dosing was initiated on Day 7 of gestation and continued to and included Day 28 of gestation.
Frequency of treatment:
Once per day.
Doses / concentrations
Remarks:
Doses / Concentrations:
30, 300, or 1000 mg/kg bw/day.
Basis:
nominal conc.
No. of animals per sex per dose:
7 groups each of 7 mated female
Control animals:
yes, concurrent vehicle

Examinations

Maternal examinations:
The following observations of does were recorded: clinical signs, gestational body weight, and food consumption.
Ovaries and uterine content:
Gravid uterine weights were recorded.
Total number of corpora lutea, implantations, early and late resorptions, and live and dad fetuses were recorded.
Fetal examinations:
Litters were delivered by laparohysterectomy on Day 29 of gestation.

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:
Maternal toxic effects:no effects

Details on maternal toxic effects:
No adverse treatment-related maternal effects were observed at any dose level.

Effect levels (maternal animals)

open allclose all
Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day
Based on:
test mat.
Basis for effect level:
other: maternal toxicity
Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day
Based on:
test mat.
Basis for effect level:
other: developmental toxicity

Results (fetuses)

Details on embryotoxic / teratogenic effects:
Embryotoxic / teratogenic effects:no effects

Details on embryotoxic / teratogenic effects:
No adverse treatment-related developmental effects were observed at any dose level.

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
The maternal and developmental rabbit NOAEL was 1000 mg/kg bw/day for test substance.
Executive summary:

Method

A pilot prenatal developmental toxicity study was performed in rabbits with CAS 32466 -46 -9, the free acid form CAS 16090 -02 -1., administered via oral gavage. 7 groups each of 7 mated female New Zealand white rabbits per group were treated once per day via oral gavage either with the vehicle alone (one control group) at the dose levels of 30, 300, or 1000 mg/kg bw/day. Dosing was initiated on Day 7 of gestation and continued to and included Day 28 of gestation. Clinical signs, gestational body weight, and food consumption were recorded. Litters were delivered by laparohysterectomy on Day 29 of gestation. Gravid uterine weights were recorded. Total number of corpora lutea, implantations, early and late resorptions, and live and dad fetuses were recorded.

Results

No adverse treatment-related maternal or developmental effects were observed at any dose level.

NOAEL maternal and developmental: 1000 mg/kg bw/day.