Benzenesulfonic acid, 2,2'-(1,2-ethenediyl)bis[5-[[4-[(2-hydroxyethyl)methylamino]-6-(phenylamino)-1,3,5-triazin-2-yl]amino]-, sodium salt (1:2)

Developmental toxicity / teratogenicity

Administrative data

Endpoint:

developmental toxicity

Type of information:

other: read-across based on grouping of substances (category approach)

Adequacy of study:

supporting 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. Justification for Read Across is reported in the endpoint summary and in the Category Justification Report attached to the Section 13.

Data source

Reference

Reference 1

Reference Type:

other: original reference

Title:

Unnamed

Year:

1998

Report date:

1998

Reference 2

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 rats..

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

OB 2A free acid

Cas Number:

32466-46-9

IUPAC Name:

OB 2A free acid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Administration / exposure

Route of administration:

oral: gavage

Duration of treatment / exposure:

Dosing was initiated on Day 6 of gestation and continued to and included Day 19 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 10 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.
Gross pathology analysis was performed after necropsy.

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 20 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:
All animals survived to the scheduled necropsy, and no treatment-related clinical observations were seen at any dose level.
No gross pathological alterations were noted at necropsy from any animal on test.
No significant treatment-related effects on body weight, body weight development, food consumption, number of corpora lutea, implantations, live fetuses, preimplantation, postimplantation or resorption rates were observed at any dose level.

Effect levels (maternal animals)

1

Dose descriptor:

NOAEL

Effect level:

1 000 mg/kg bw/day

Based on:

test mat.

Basis for effect level:

other: maternal toxicity

2

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 treatment-related effects on gravid uterus or adjusted body weight 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 rat NOAEL was 1000 mg/kg bw/day for test substance.

Executive summary:

Method

A pilot prenatal developmental toxicity study was performed in rats with OB 2A free acid, administered via oral gavage. 7 groups each of 10 mated female Sprague-Dawley rats 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 6 of gestation and continued to and included Day 19 of gestation. Clinical signs, gestational body weight, and food consumption were recorded. Litters were delivered by laparohysterectomy on Day 20 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.