Sodium 3-(2H-benzotriazol-2-yl)-5-sec-butyl-4-hydroxybenzenesulfonate

Endpoint summary

Description of key information

A 5 day range-finding experiment was performed to provide a basis to propose the dose levels for the 28-day study. A 28-day repeated toxicity oral study with the test item sodium 3-(2H-benzotriazol-2-yl)-5-sec-butyl-4-hydroxybenzenesulfonate was performed in rats. The derived no adverse effect level (NOAEL) was 200 mg/kg bw/day. 

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion

Dose descriptor:

NOAEL

200 mg/kg bw/day

Additional information

Supporting study (5 -day range-finding):

In a range-finding study, sodium 3-(2H-benzotriazol-2-yl)-5-sec-butyl-4-hydroxybenzenesulfonate was administered to Wistar rats by repeated oral gavage, for a period of 5 days. The study was comprised of three groups, each containing three male and three female rats. There were no changes in the animal clinical condition, body weight or food consumption. A significant increase of absolute liver weights was observed in male rats of group 3, whereas an increase in liver to body weight ratios was observed in male and female rats of the same group, when compared to controls and group 2. Additionally, the absolute and relative adrenal weights of the female rats of group 3 were decreased when compared to the animals of both other groups. There were no ophthaloscopic changes observed. No findings, related to test article treatment mere observed. According to the results observed, it is recommended to select the following dose groups for the subacute 28-day oral (gavage) study: 20, 50, 200 and 800 mg/kg bw.

Key study (28 -day):

A 28-day oral (gavage) toxicity study was performed with sodium 3-(2H-benzotriazol-2-yl)-5-sec-butyl-4-hydroxybenzenesulfonate in male and female Wistar rats according to OECD 407 Guideline and EC Method B.7. Dose levels administered in this study were selected based on data obtained during a 5-day dose-range-finding toxicity study. A control, four dose groups and a high dose and control recovery group (n= 5 animals per group and sex) were involved in the study. The test item was administered at concentrations of 0, 20, 50, 200 and 800 mg/kg bw prepared in carboxymethyl cellulose (4 %), at a 10 mL/kg bw treatment volume. There were no changes in the animal clinical condition, body weight or food consumption. A statistically significant increase in absolute and relative liver weights were observed in male and female rats at termination of the treatment period at 200 mg/kg bw/day. However, no histopathological correlation or changes in enzymes activities indicating aphysiological damage of the liver were found. Thus, these findings were considered to be adaptive and not adverse. No other effects were observed at 200 mg/kg bw/day. Additionally, the absolute weights of the adrenals were statistically significant decreased in males at termination of the treatment and treatment free (recovery) period at 800 mg/kg bw/day. There was no evidence of abnormal histopathological findings and no effects at clinical laboratory investigations (haematology, clinical biochemistry, urinanalysis) or any other parameter at any test dose investigated. In conclusion, based upon the results obtained in this study, the "no adverse effect level" (NOAEL) of sodium 3-(2H-benzotriazol-2-yl)-5-sec-butyl-4-hydroxybenzenesulfonate is 200 mg/kg bw for male and females rats when administered orally by gavage for a period of 28 days.

Justification for classification or non-classification

Based on a subacute repeated oral toxicity study, test item sodium 3-(2H-benzotriazol-2-yl)-5-sec-butyl-4-hydroxybenzenesulfonate was not classified and labelled according to Directive 67/548/EEC (DSD) and to Regulation /EC) No 1272/2008 (CLP).