Isostearic acid, esters with methyl α-D-glucoside

Endpoint summary

Description of key information

Skin irritation:
rabbit, 4 hrs, semi-occlusive, not irritating to skin
Eye irritation/Corrosion: 
rabbit, 100 µl, unrinsed: no eye irritation
Respiratory irritation: no inhalation study performed (waiver) due to very low  volatility of test substance and no exposure to aerosols, particles or droplets of an inhalable size at the working place 

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

Skin irritation

In a primary dermal irritation study according to OECD Guideline 404 three young adult male New Zealand White rabbits were dermally exposed to 0.5 g of Isostearic acid, esters with methyl α-D-glucoside unchanged for 4 hours. Two animals then were observed for 72 hours and one animal for 14 days, respectively. Irritation was scored by the method described in OECD Guideline 404.

Very slight erythema in the treated skin areas of all three animals was observed after 60 minutes, which had resolved within 24 h after exposure in two animals and within 7 days after exposure in one animal. Scaliness in the treated skin area of one animal was noted at 72 hours and 7 days post-treatment and had resolved within 14 days.

In this study, Isostearic acid, esters with methyl α-D-glucoside is not a dermal irritant.

 

Eye irritation

In a primary eye irritation study according to OECD Guideline 405 0.1 ml of Isostearic acid, esters with methyl α-D-glucoside, was instilled unchanged into the conjunctival sac of one eye, each of three New Zealand White rabbits. The eyes were not washed. Animals were then observed for 72 hours. Irritation was scored according to OECD Guideline 405.

No iridial irritations or corneal opacity were observed. The conjunctival redness (score 1), which was induced in all three animals at the first hour was fully reversible within 24 hours.

In this study, Isostearic acid, esters with methyl α-D-glucoside is not an eye irritant.

Respiratory irritation

No inhalation studies have been performed as inhalation is not a relevant exposure path for this substance due to its very low vapour pressure and because no exposure to aerosols, particles or droplets of an inhalable size has to be assumed at the working place.

Justification for classification or non-classification

According to Directive 67/548/EEC as well as GHS Regulation EC No 1272/2008 Isostearic acid, esters with methyl α-D-glucoside has not to be classified or labelled with respect to skin, eye and respiratory irritation.