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Administrative data

Description of key information

The acute oral toxicity of Butanedioic acid, sulfo-, 4-C16-18 (even numbered)-alkyl esters, disodium salts (CAS 90268-36-9) was derived from a key study with read across substance CAS 90268-36-3 containing ≥90% act. ingr., showing LD50 values of <1400 mg/kg and >580 mg/kg for male rats and <1400 mg/kg and >580 mg/kg for female rats.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
580 mg/kg bw
Quality of whole database:
Reliable

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

No acute toxicity data were available for the target substance (Butanedioic acid, sulfo-, 4-C16-18 (even numbered)-alkyl esters, disodium salts: CAS 90268-36-9), but read across data were available from source substance CAS 90268-36-3:

- The acute oral toxicity of read across substance CAS 90268-36-3 containing ≥90% act. ingr. was tested in a key study by oral gavage in young Wistar rats at dose levels of 580, 1400 and 2000 mg/kg bw. The test compound was administered by single gavage in aqua dest. as solvent and an application volume of 20 mL/kg bw to fasted animals. Two (low and mid dose) or five rats (high dose) were used per sex and dose. Clinical observations and gross macroscopic observations were observed at all dose levels . The LD50was <1400 mg/kg and >580 mg/kg for male rats and <1400 mg/kg and >580 mg/kg for female rats (Potokar, 1987).

- The acute oral toxicity of read across substance CAS 90268-36-3 containing >= 90% act. ingr. was tested in a supporting study by oral gavage in male Wistar rats. The test item was administered by single gavage in aqua dest. as solvent and an application volume of 20 mL/kg bw to fasted animals at doses of 1.58, 1.99, 2.51 and 3.16 g/kg bw. Ten male rats were used per sex and dose. All animals in all dose groups displayed diarrhea. The LD50was 2.4 g/kg bw (Gloxhuber, 1969).

- Acute oral toxicity of read across substance CAS No. 90268-36-3 containing >= 90% act. ingr. was tested in a supporting study by oral gavage in male and female Wistar rats. The male LD50 was > 2000 mg/kg bw; the female male LD50 was ca. 1400 mg/kg bw (Potockar, 1986).

Justification for classification or non-classification

Based on the available data, the oral LD50 of Butanedioic acid, sulfo-, 4-C16-18 (even numbered)-alkyl esters, disodium salts in Wistar rats was established to be between 300-2000 mg/ kg body weight, therefore the substance is classified category 4 for oral toxicity according to CLP Regulation (EC) No. 1272/2008.