Sulphophthalic acid derivatives reaction products of fatty alcohol C12-C14 and sodium hydroxide

Endpoint summary

Description of key information

Not skin irritant

Eye irritation/corrosion inconclusive waiting for the results of the BCOP study

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)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation/corrosion

The EpiSkinTMSM test of Dilasoft TF has been performed to predict its irritation potential by measurement of its cytotoxic effect, as reflected in the MTT assay, according to the OECD Test Guideline No. 439.

Disks of EPISKIN (three units) were treated with test item and incubated for 15 minutes (± 0.5 min) at room temperature. Exposure of test material was terminated by rinsing with PBS 1x solution. Epidermis units were then incubated at 37 ± 1 °C for 42 hours (± 1 h) in an incubator with 5 ± 1 % CO2, ≥ 95 % humidified atmosphere. The viability of each disk was assessed by incubating the tissues for 3 hours (± 5 min) with MTT solution at 37 ± 1 °C in 5 ± 1 % CO2 protected from light. The precipitated formazan was then extracted using acidified isopropanol and quantified spectrophotometrically.

The test item has an intrinsic colour (yellow), therefore two additional test item treated tissues were used for the non-specific OD evaluation.

SDS (5 % aq.) and 1×PBS treated (three units / positive and negative control) epidermis were used as positive and negative controls respectively. For each treated tissue viability was expressed as a percentage relative to negative control.

In thisin vitroskin irritation test using the EPISKIN model, the test item did not show significantly reduced cell viability in comparison to the negative control (mean value: 109 %). All obtained test item viability results were far above 50 % when compared to the viability values obtained from the negative control. Therefore the test item was considered to be non-irritant to skin.

Positive and negative controls showed the expected cell viability values within acceptable limits.The experiment was considered to be valid.

 

Eye irritation/corrosion

The purpose of the first in vitro study was to determine the acute ocular irritation potential of the test item on three-dimensional RhCE tissue in the EpiOcular™ model in vitro, according to the OECD guideline 492.

At the end of the Post-Soak immersion test item treated tissues were incubated for 120 minutes ± 15 minutes at standard culture conditions (Post-treatment Incubation). Fresh Assay Medium was used during the Post-Soak and Post-incubation. The viability of each disk was assessed by incubating the tissues for 3 hours with MTT solution at 37 ± 1 °C in an incubator with 5 ± 1 % CO₂protected from light, 90 ± 10 % humidified atmosphere. The precipitated formazan was then extracted using isopropanol and quantified spectrophotometrically. Sterile deionized water and methyl acetate treated tissues were used as negative and positive controls, respectively. The Disks of EpiOcular™ (two units / control) were treated with positive and negative control and incubated for 30 minutes ± 2 minutes.

The test item showed significantly reduced cell viability in comparison to the negative control (mean viability: 44 %). All obtained test item viability results were below 60 % when compared to the viability values obtained from the negative control.

Positive and negative controls showed the expected cell viability values within acceptable limits. The experiment was considered to be valid.

The results obtained from this in vitro eye irritation test, using the EpiOcular™ model, with the test item indicated that the test item is irritant and/or able to cause serious eye damage. However, this test method cannot resolve between UN GHS Categories 1 and 2.

A second in vitro study, according to the OECD 437 (BCOP), is in progress and will clarify the toxicity of the substance in contact with the eyes. The dossier will be updated as soon as new results are available.

Justification for classification or non-classification

Skin Irritation

Accepted in vitro test methods to detect skin corrosion/irritation (i.e. Category 1 and 2 under CLP) and/or absence of effects (i.e. not classified under CLP) have been applied to assess the skin irritation/corrosion potential of the test substance, according to the Integrated Approach on Testing Strategy (IATA).

The substance was tested for its potential to induce skin irritation according to the OECD guideline 439. No toxic effects were seen under test conditions, therefore test substance resulted non-corrosive to the skin. However this test method alone, as reported in ECHA guidance R.7a (v.6.0, July 2017), cannot detect wheter the substance is skin irritant or not skin irritant.

For this reason a second experiment was carried out according to the OECD guideline 439.

Under test condition the substance shows a mean viability always above the threshold of 50 % therefore, it was not classified as skin irritant, according to the CLP Regulation n. 1272/2008.

Eye Irritation

In vitro test methods to detect serious eye damage (Category 1 under CLP) and/or absence of effects requiring classification for serious eye damage/eye irritation (i.e. not classified under CLP) are accepted for REACH purposes.

This tests are used in an Integrated Approach on Testing Strategy (IATA) in order to determine the final toxicity of a substance.

A in vitro study carried out according to the OECD 492, is available, and indicated that the test item is irritant and/or able to cause serious eye damage. However, this test method cannot resolve between Categories 1 and 2 of the CLP Regulation.

For this reason a study according to the OECD guideline 437 is currently in progress. The "eye irritation/corrosion" end-point is therefore considered as inconclusive until new data is available.