Reaction mass of 1,2-Benzenedicarboxylic acid, 4-sulfo-, trisodium salt, 1,2-Benzenedicarboxylic acid, 3-sulfo-, sodium salt (1:3), Sodium sulphate

Endpoint summary

Description of key information

The acute oral LD50 of Produkt SPS after single oral administration to female rats is > 2000 mg/kg bw.
The acute dermal LD50 of Produkt SPS after single dermal application in male and female rats is > 2000 mg/kg bw. 

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Additional information

Acute oral toxicity

In a GLP compliant study, according to OECD guideline 423, the acute oral toxicity of Produkt SPS following a single oral administration in female Wistar rats was investigated (Bioassay, 2012). Two groups of fasted animals (3/group) were treated by gavage with Produkt SPS in 0.5% solution of CMC in deionized water at a dose level of 2000 mg/kg bw and observed for 14 days. All animals survived until the end of the study period. No clinical signs were observed during the course of the study. The mean body weight increased within the normal range throughout the study period. One animal of the first test group showed stagnation of body weight during the second post-exposure week. No macroscopic findings were observed at necropsy. The acute oral LD₅₀of Produkt SPS after single oral administration to female rats is > 2000 mg/kg bw.

Acute dermal toxicity

In a GLP compliant study, according to OECD guideline 402, the acute dermal toxicity of Produkt SPS following a single dermal application in male and female Wistar rats was investigated (Bioassay, 2012). A group animals (5/sex) was dermally exposed to Produkt SPS in 0.5% solution of CMC in deionized water at a dose level of 2000 mg/kg bw for 24 hours under semi-occlusive dressing and observed for 14 days. All animals survived until the end of the study period. There were no signs of systemic toxicity and no signs of skin effects. The mean body weight of the animals increased within the normal range throughout the study period, with the exception of two females which showed stagnation of body weight during the first post-exposure week, but gained weight in a normal range during the second week. No macroscopic pathologic abnormalities were noted in the animals examined at the end of the study. The acute dermal LD₅₀of Produkt SPS after single dermal application in male and female rats is > 2000 mg/kg bw.

Justification for classification or non-classification

Based on the available acute oral and dermal toxicity study, no classification and labeling is required (according to Directive 67/548/EEC and according to CLP).