2-Amino-5-methylbenzensulfonic acid was studied for oral toxicity in rats in an OECD preliminary reproduction toxicity screening test at doses of 0, 100, 300 and 1000 mg/kg/day.
In the repeat dose toxicity, the test substance had no effects on general condition, body weights, food consumption, necropsy findings, organ weights and histopathological findings for the testes, epididymis and ovaries.
NOELs for repeat dose toxicity are considered to be above 1000 mg/kg/day for both sexes.
In terms of reproductive/developmental toxicity, the test substance showed no effects on any relevant parameters.
NOELs for reproductive and developmental toxicity are considered to be above 1000 mg/kg/day for both parental animals and offspring.
| Purity | : | 99.30 wt% |
| Test species/strains | : | Rat/Crj:CD(SD) |
| Test method | : | OECD Preliminary Reproduction Toxicity Screening Test |
| Route | : | Oral (gavage) |
| Doses | : | 0 (vehicle), 100, 300, 1000 mg/kg/day |
| Number of animals/group | : | Males, 12; females, 12 |
| Vehicle | : | Sesame oil |
| Administration period | : | Males, 48 days Females, from 14 days before mating to day 3 of lactation |
| Terminal kill | : | Males, day 48 Females, day 4 of lactation |
| GLP | : | Yes |
Test results:
The test substance had no effects on general condition, body weights, food consumption nor necropsy findings in both sexes. No test-compound related diferences were observed in the testes and epididymides weights of the male animals. In the histopathological findings, there were no adverse effects of the test substance on the reproductive organs in either sex.
NOELs for repeat dose toxicity are considered to be above 1000 mg/kg/day for both sexes.
<Reproductive and developmental toxicity>
As for the reproductive ability of parent animals, no effects were detected in the copulation index, fertility index, gestation length, number of corpora lutea or implantations, implantation index, gestation index, delivery index, purturition 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 weights. No abnormal findings related to the test substance were noted for external features, clinical signs, or on necropsy findings for the offspring.
NOELs for reproductive and developmental toxicity are considered to be above 1000 mg/kg/day for both parental animals and offspring.
| 1) | The tests were performed by the Biosafety Research Center, Foods, Drugs and Pesticides (An-pyo Center), 582-2 Shioshinden Arahama, Fukude-cho, Iwata-gun, Shizuoka, 437-1213, Japan. Tel +81-538-58-1266 Fax +81-538-58-1393 |