4,4'-Diamino-2,2'-stilbenedisulfonic acid

4,4'-ジアミノ-2,2'-スチルベンジスルホン酸

CAS No. 81-11-8

Molecular formula: C14H14N2O6S2　Molecular weight: 370.42

ABSTRACT

With regard to repeat dose toxicity, the test substance had no effect on clinical signs, body weight, food consumption, necropsy findings, organ weights and histopathological findings for the testis and epididymis.

The NOELs for repeat dose toxicity are considered to be over 1000 mg/kg/day for both sexes.

In terms of reproductive/developmental toxicity, the compound showed no effects on any relevant parameters.

The NOELs for reproductive and developmental toxicity are considered to be 1000 mg/kg/day for both parental animals and offspring.

SUMMARIZED DATA FROM THE STUDIES

1. Preliminary Reproductive/Developmental Toxicity1)

Purity	:	92.02%
Test species/strain	:	Rat/Crj:CD (SD)
Test method	:	OECD Preliminary Reproduction Toxicity Screening Test
Route	:	Oral (gavage)
Doses	:	0 (vehicle), 40, 200, 1000 mg/kg/day
Number of animals	:	Male, 10; female, 10/group
Vehicle	:	0.5% Sodium Carboxymethyl Cellulose solution
Administration period	:	Males, 41 days Females, from 14 days before mating to Day 3 of lactation
Terminal kill	:	Males, Day 42 Females, Day 4 of lactation
GLP	:	Yes

　Test results:

<Repeat dose toxicity>

The test substance had no effects on clinical signs, body weight, food consumption or necropsy findings in either sex. Testicular and epididymal weights were similar among all four groups. No histological changes ascribed to the test substance in these reproductive organs were observed in any of the male rats.

The NOELs for the repeat dose toxicity are considered to be over 1000 mg/kg/day for both sexes.

<Reproductive and developmental toxicity>

Parental animals exhibited no effects on reproductive parameters including the copulation index, fertility index, gestation length, number of corpora lutea or implantations, implantation index, gestation index, delivery index, parturition or maternal behavior. There were no significant differences in numbers of offspring or live offspring, sex ratio, the live birth index, the viability index or body weight. No abnormal findings attributable to the test substance were noted on external examination, in clinical signs, or on necropsy of the offspring.

The NOELs for reproductive and developmental toxicity are considered to be over 1000 mg/kg/day for both parental animals and offspring.

1)	The tests were performed by the Mitsubishi Chemical Safety Institute Ltd., 14 Sunayama, Hasaki-machi, Kashima-gun, Ibaraki, 314-02, Japan. Tel +81-479-46-2871 Fax +81-479-46-2874