Alkyl phosphites

Endpoint summary

Description of key information

The results of the OECD 404 (Acute Dermal Irritation/Corrosion) study revealed the registration substance to be corrosive to the skin. 
A further eye irritation test was not performed and the registration substance was concluded to be corrosive to the eyes. 

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation/corrosion:

Experimental data on skin irritation/corrosion is available from an animal study in rabbits

The dermal corrosion/irritation test was conducted in accordance with OECD guideline 404 and EU Method B4. The study was to GLP standard. The test substance was found to be corrosive, overt signs of corrosivity (blanching and/or necrosis) were observed in this animal at the 1 hour and 4 hour exposure sites at the 60 minute, 24, 48, and 72 hour dermal evaluations. There was no sign of corrosivity at the three minutes exposure site during the test period. At the four hour exposure site, severe erythema and edema (ranging from very slight to severe) were observed from the 60 minute to Day 7 observation intervals. Severe erythema persisted, but no edema was noted on Day 10. Irritation decreased by the Day 14 observation when only slight erythema and edema were noted. In addition to blanching and necrosis, other supplemental dermal observations at the 4 hour site included desquamation, exfoliation, leathery skin and eschar. The irritation observed at the 1 hour exposure was essentially equivalent to the irritation seen at the 4 hour exposure. Irritation observed at the 3 minute exposure was slightly reduced and there were no apparent signs of corrosivity.

In conclusion, the test substance was corrosive to the skin under the conditions of the OECD 404 study. Further, the substance will also be considered corrosive to the eyes.

Justification for selection of skin irritation / corrosion endpoint:
Key study for this endpoint. GLP study conducted in accordance with OECD guideline 404. The reliable GLP compliant OECD guideline was chosen.

Justification for selection of eye irritation endpoint:
The registration substance was concluded to be corrosive to the eyes based on the finding of the skin irritation/corrosion study. In accordance with Column 2 of Annex VII-VIII, section 8.2 of the REACH regualtion an eye irritation study does not need to be conducted, as the substance os classified as corrosive to the skin.

Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Justification for classification or non-classification

Skin irritation/corrosion:

Overt signs of corrosivity (blanching and or/necrosis) were observed in the test animal at the 1 hour and 4 hour exposure sites at 60 minute, 24, 48 and 72 hour dermal evaluations and were not fully reversible up to the end of the 14 day observation period. There was no sign of corrosivity at the three minute exposure site during the test period. Therefore is accordance with Regulation (EC) No 1272/2008 (CLP) the registration substance will be classified as Category: Corrosive 1B (H314: Causes severe skin burns and eye damage).

Eye irritation:

The Eye Irritation/Corrosion test was not performed and the registration substance is already classified

Corrosive 1B (H314: Causes severe skin burns and eye damage).

in accordance with Regulation (EC) No 1272/2008 (CLP).