Reaction products of dimethyl phosphonate with 2-alkyl-2-alkylpropanediol and alkanediol

Endpoint summary

Description of key information

Skin corrosion in vitro

The test item was determined to be corrosive to skin becausecell viability was determined to be 84.7 % after 3 minutes and 6.1 % after 60 minutes (OECD 431; EpiDerm Human Skin Model).

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin corrosion in vitro

The key study was performed in compliance with the OECD Guideline for the Testing of Chemicals No 431 In Vitro Skin Corrosion: Reconstructed Human EpiDermis (RHE) Test Method (28 July 2015) and Method B.40 bis of Commission Regulation (EC) No 440/2008 of 30 May 2008, laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). The purpose of the test was to evaluate the corrosivity potential of the test item using the EpiDerm Human Skin Model after treatment periods of 3 and 60 minutes. Corrosion is directly related to cytotoxicity in the EpiDerm tissue and cytotoxicity is determined by reduction of MTT (3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyltetrazolium bromide) to formazan by viable cells in the test item-treated tissues relative to the corresponding negative control. The results are used to make a prediction of the corrosivity potential of the test item.

Duplicate tissues were treated with the test item for exposure periods of 3 and 60 minutes. Negative and positive control groups were treated for each exposure period. At the end of the exposure period the test item was rinsed from each tissue before each tissue was taken for MTT-loading. After MTT loading each tissue was placed in 2 mL Isopropanol for MTT extraction. At the end of the formazan extraction period each well was mixed thoroughly and triplicate 200 μL samples were transferred to the appropriate wells of a pre-labelled 96-well plate. The optical density (OD) was measured at 570 nm (OD570). Datawerepresented in the form of percentage viability (MTT reduction in the test item treated tissues relative to negative control tissues).

Relative mean viabilities after 3-minute exposure were determined to be 100 % (negative control), 3.6 % (positive control) and 84.7 % (test item. Relative mean viabilities after 60-minute exposure were determined to be 100 % (negative control), 4.0 % (positive control) and 6.1 % (test item).

 

Skin irritation in vitro

The study need not be conducted because the available information indicates that the criteria are met for classification as corrosive to the skin or irritating to eyes.

 

Skin irritation in vivo

The study need not be conducted because the available information indicates that the criteria are met for classification as corrosive to the skin or irritating to eyes.

 

Eye damage/irritation in vitro

The study need not be conducted because the available information indicates that the criteria are met for classification as corrosive to the skin or irritating to eyes.

 

Eye damage/irritation in vivo

The study need not be conducted because the available information indicates that the criteria are met for classification as corrosive to the skin or irritating to eyes.

Justification for classification or non-classification

Skin corrosion

The test item was considered to be corrosive to skin because cell viability was determined by OECD 431 (28 July 2015) to be ≥ 50 % after 3 minutes but < 15 % after 60 minutes using the EpiDerm Human Skin Model. Since OECD 431 does not permit distinction between categories 1B and 1C, the worst-case classification (skin corrosive category 1B) is applicable under the terms of Regulation (EC) No. 1272/2008. A specific concentration limit is not applicable because the test item was determined to be surface active and the additivity approach is not appropriate.

 

Eye damage/irritation

Since the substance has been determined to be corrosive to skin, and in accordance with Regulation (EC) No 1272/2008 (8th ATP; 19 May 2016), it is appropriate to assign H314 “Causes severe skin burns and eye damage” and omit H318 “Causes serious eye damage”.