Butanedioic acid, sulfo-, monoesters with lanolin alcs., disodium salts

Endpoint summary

Description of key information

Repeated oral toxicity:  Sulfosuccinate portion NOAEL of 30 mg/Kg, no effect on body weight, gross and microscopic  tissue observation, haematological, blood chemistry, or urinalysis parameters. The Lanoline portion (test performed on Cholesterol) didn't define specific toxicity on organs, especially for the liver.

Repeated inhalation toxicity: data waiving  is based on exposure consideration.

Repeated dermal toxicity: repeated application test on humans available (section 7.10.4)

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

NOAEL

30 mg/kg bw/day

Study duration:

chronic

Species:

dog

Quality of whole database:

Several studies are available on analogues substances, but with no clear indication of the effect level. The quality of the database is then considered of medium level

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Sulfosuccinate of Lanoline Alcohol is chemically a complex substance. Some studies on Sulfosuccinates are reported to indicate the tested toxicity for a portion of the molecule. Lanoline is the other portion of the molecule; the study related to this portion was assessed with an available test performed with Cholesterol.

The repeated toxicity of Dioctyl Sodium Sulfosuccinate was tested orally on dog, for 1 year (chronic exposure).

The NOAEL was defined => 30 mg/Kg. There were no effects on body weight, gross and microscopic tissue observation, haematological, blood chemistry, or urinalysis parameters.

Lanoline is the other portion of the molecule; the repeated toxicity of Lanoline portion was assessed with Cholesterol study, due to the sterol similarity. This latter didn't define specific toxicity for organs, especially for the liver.

Data waiving of repeated inhalation toxicity is based on exposure consideration, while for repeated dermal toxicity several repeated application studies on humans are available (section 7.10 .4).

Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:

The study was selected because it is a chronic test.

Justification for selection of repeated dose toxicity inhalation - systemic effects endpoint:

Exposure consideration

Justification for selection of repeated dose toxicity inhalation - local effects endpoint:

Exposure consideration

Justification for classification or non-classification

Repeated oral toxicity

The substance Sulfosuccinate of Lanolin Alcohol is not classified orally toxic because it doesn't meet the classification criteria of the CLP regulation n. 1272/2008 on repeated exposure:

Category 1: substances that have produced significant toxicity in humans or that, on the basis of evidence from studies in experimental animals, can be presumed to have the potential to produce significant toxicity in humans following repeated exposure.

Category 2: substances that, on the basis of evidence from studies in experimental animals can be presumed to have the potential to be harmful to human health following repeated exposure.

No oral repeated toxicity on organs was observed in test related to the portions of the molecule (Lanoline alcohol and Sulfosuccinates).