Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Data waiving:
other justification
Justification for data waiving:
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
Acute and repeated dose testing via oral route indicate that Sodium diisobutylnaphthalenesulphonate (ANS DIB; C8-alkyl naphthalene sulfonate) is of relative low systemic toxicity. Although the acute testing resulted to aLD50 cut-off value of 500 mg/kg, lethality was only seen following 2000 mg/kg, and necropsy of dead animals revealed blood in parts of the gastrointestinal tract, suggestive for local effects rather than systemic toxicity. This is confirmed in the repeated dose toxicity study where some mortality was seen following dosing at 700 mg/kg bw where the effects in the stomach (ulceration, erosion) might have contributed to the morbidity. Also the NOAEL is based on local effects, and close examination shows that the only effects observed at 200 mg/kg are a slight lower BW compared to control (-6%) in males, and an increased combined effects in stomach upon histopathological examinations in males. Also should be considered that ANS DIB is not expected to easily pass the skin in view of its ionised form at physiological conditions, and as the substance is irritating to skin, and effects will be characterized by irritation rather than systemic toxicity.
The product itself is a powder and is only applied industrially in formulation steps involving high control of exposures with the application of PPE, especially considering that the substance is classified as irritating to the skin. Also the indicated end use only involves professional applications. As the substance is irritating to skin, and is of relatively low acute toxicity, and in practice dermal absorption from a dry powder is limited, further testing for acute toxicity via the skin is not considered to bring more relevant hazard information.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion