Naphthalene sulfonic acid, reaction products with isobutanol,sodium salts

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING
Testing of Sodium diisobutylnaphthalenesulphonate (ANS DIB; C8-alkyl naphthalene sulfonate) for acute inhalation toxicity is not appropriate. The vapour pressure of the test substance was determined to be 1.7 × 10-4 Pa at 25 °C. Due to the very low vapour pressure inhalation of vapours leading to irritation of airways will not occur. Also the particle size is also mostly above respiratory size with a D50 of 20.6 µm. The product itself is only applied industrially in formulation steps involving high control of exposures. Also the indicated end use only involves professional applications. Testing for acute toxicity by inhalation route is therefore generally not needed according to REACH regulation (EC) 1907/2006 (Annex VIII, point 8.5, column 2).
Furthermore, testing would also not be justified because of animal welfare reasons based on severe effects especially on mucosal epithelium. C7-alkyl naphthalene sulfonate has proven to be irritating to skin showing low to no recovery, cat.1 damaging to the eyes and showing irritating and corrosive potential as based on local effects in stomach following acute and repeated oral, whereas otherwise systemic toxicity is low.