2,3-epoxypropyltrimethylammonium chloride

Endpoint summary

Description of key information

Skin: not irritating (Kr. 2, EU RAR, 2008)
Eye: irreversible eye damage (Kr. 2, EU RAR, 2008)

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:

adverse effect observed (irritating)

Additional information

Skin:

In a skin irritation study (Degussa, 1985), considered as a Key study and performed similarly to the OECD guideline No. 404, three albino rabbits were exposed to 0.5 mL of the commercial preparation of 2,3-Epoxypropyltrimetylammonium Chloride (EPTAC) (referred as QUAB 151) for 4h under occlusive patch. The concentration was assumed varying between 70 and 75%.

The test sample was instilled on four separate shaved locations. One side of the back the skin was abraded while the other remained intact. For the calculation of irritation index, the scores from the intact areas were included only. The scoring was done within 1, 24, 48 and 72 hours after the end of the treatment. All the individual scores of the non-abraded skin treated with EPTAC were zero at all time points.

 

Another study was available(Degussa, 1981c) where positive results for skin irritation were obtained. However, these positive results were obtained with worst case experimental conditions such as occlusive patch method and an exposure duration of 24h instead of a 4h exposure under semi-occlusive conditions according to the requirements of the current OECD guideline. Therefore, the results of this study are not considered to be relevant to draw a conclusion on skin irritation of EPTAC.

 

In conclusion, considering the results obtained in the Key study, the test item is not classified as irritating to skin according to the criteria of the CLP regulation (No. 1272/2008) and of the Directive 67/548/EEC.

Eyes:

In an eye irritation study (Degussa, 1986a) performed according to the OECD guideline No. 405 protocol, 0.1 mL of a commercial solution (referred as QUAB 151) of 2,3-epoxypropyltrimethyl ammonium chloride (purity assumed to be 70-75%) (EPTAC) was instilled into the conjunctival sac of the right eye of three albino rabbits. No rinsing was performed. Cornea, iris and conjunctiva was examined and scored qualitatively and quantitatively after 1, 24, 48 and 72 hours. The rabbits were then observed for 21 days. EPTAC was severely irritating to eyes considering the scores obtained for the iris lesion (> 1.5). Furthermore, the effect on iris was persistent within 21 days in one animal which is also a criterion to classify the test substance as severe irritating to eyes.

 

Therefore, under the test conditions, EPTAC is classified as Eye Dam. 1 (H318, Causes serious eye damage) according to the CLP regulation (No. 1272/2008) and as Risk of serious damage to eyes (Xi, R41) according to the Directive 67/548/EEC.

Effects on eye irritation: highly irritating

Justification for classification or non-classification

Harmonised classification:

2,3-Epoxypropyltrimetylammonium Chloride (EPTAC) is classified as Eyes Dam. 1 (H318: Causes serious eye damage) in the Annex VI, Table 3.1 of the CLP regulation (No 1272/2008) and as severe irritating to eyes (Xi, R41: Risk of serious eye damages) in the Annex VI, Table 3.2 of the CLP regulation (1272/2008).

No additionnal self-classification is proposed