C12-14 (even numbered) alkyl glycosides, oligomeric and C12-14 (even numbered) alkyl glycosides, oligomeric, carboxymethyl ethers, sodium salts

Endpoint summary

Description of key information

Based on the results of an in vitro combined corrosion/irritation assay (OECD TG 431 and OECD TG 439; BASF 61V0695/11A565, 2012) conducted with Plantapon LGC Sorb (aqueous prep. containing 31.1% a.i.) it is concluded that the test item is not a skin irritant.
Based on an vivo study conducted with rabbit according to the OECD TG 405, it is concluded that the test item has an eye irritant potential (C0201045-0, 2002). This was supported by the results obtained from 2 in vitro approaches, the BCOP assay (OECD TG 437; BASF 63V0675/11A364, 2012) and the EpiOcular™ eye irritation assay (BASF 62V0675/11A363, 2012).

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

The corrosive and the irritant potential of the test item Plantapon LGC Sorb (aqueous prep. with 31.1% a.i.) was assessed in the in vitro Human epidermis model EpiDerm™, according to the OECD TG 431 and 439, respectively (BASF 61V0675/11A565, 2012).

Briefly, the EpiDerm™ tissue samples were incubated with the test item for 3 minutes and 1 hour for the corrosion assay, and for 1 hour followed by a 42 h post treatment period, for the irritation assay. Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure using a colorimetric test. The reduction of mitochondrial dehydrogenase activity, measured by reduced formazan production after incubation with a tetrazolium salt (MTT) was chosen as suitable endpoint. The formazan production of the test-substance treated epidermal tissues was compared to that of negative control tissues by measuring the optical density (OD) at a wavelength of 570 nm. The quotient of both values indicates the relative tissue viability.

For the corrosion assay, the mean viability of the test item treated tissues after an exposure period of 3 minutes was 104%, and it was 105% after an exposure period of 1 hour.

For the irritation assay, the mean viability of the test item treated tissues determined after of 1 hour of exposure followed by 42 hours post-exposure was 102%.

Based on the observed results and applying the evaluation criteria as recommended by the guidelines, it was concluded, that the test item showed no skin irritation potential in the EpiDerm™ skin corrosion/irritation test under the test conditions chosen.

By worse-case consideration, the first study was retained for assessement of the skin irritant potential of the test item

EYE

The potential of Plantapon LGC Sorb to cause serious damages to the eye was assessed in the in vitro BCOP assay according to the OECD TG 437 by a single application of a 10% aqueous test item solution onto the epithelial surface of isolated bovine cornea (BASF 63V0675/11A364, 2012). Two assays were done. The first assay followed the surfactant protocol OECD TG 437 and consisted of one run; application time was 10 minutes followed by 2 h post incubation, and NaOH was used as positive control. The second assay used a modified surfactant protocol and comprised 2 runs (first including NaOH as positive control; second including ethanol as positive control); application time was 1 hour, followed by 1 h post incubation. Negative controls were added. Three corneas per run were used. Corneal opacity was measured quantitatively as the amount of light transmission through the cornea. Permeability was measured quantitatively as the amount of sodium fluorescein dye that passes across the full thickness of the cornea. Both measurements were used to calculate the In Vitro Irritancy Score IVIS of the test item. In addition, to provide some additional information on the potential corrosiveness of the test item, cross sections were made from the treated cornea and evaluated histopathologically after having been stained with hematoxylin and eosin. The findings were designed as absent (no findings), minimal, mild, moderate or moderate/severe.

In the first assay following the surfactant protocol OECD TG 437 the results did not indicate any serious eye damage due to the test item; however, histopathology summarized for all treated cornea revealed changes indicating mild eye damage. In both runs conducted within the second assay (modified surfactant protocol), the mean IVIS values were just below the threshold of 55 for the prediction of "risk of serious eye damage", i.e. 42.1 and 48.4 for the first and second run, respectively. In fact, the variability of individual cornea values ranged between 29.8 and 58.2 in the 1st run and 38.2 and 61.5 in the 2nd run. The mean IVIS of both runs was calculated to be 45.3. Histopathology of the first run could not be evaluated due to severe artefacts. histopathology of the second test run revealed changes indicating moderate to severe eye damage in 2/3 cornea; the third cornea could not be evaluated due to artefacts. Based on the results of the assays, a risk for Plantapon LGC Sorb to result in serious eye damages cannot fully be excluded. Furthermore, the test method according to the regulatory accepted protocol at the time of reporting does not allow for the evaluation of eye irritation. The result does not exclude an irritation potential of the test substance.

In a second in vitro approach, the potential of Plantapon LGC Sorb to cause serious eye irritation was assessed in the EpiOcularTM Eye Irritation Test. This in vitro approach has been validated in-house by BASF SE (Kolle et al., In-house validation of the EpiOcularTM Eye Irritation Test and its combination with the bovine corneal opacity and permeability test for the assessment of ocular irritation. Altern Lab Anim 39(4): 365-387, 2011). Two EpiOcular™ tissue samples were incubated with the test item. Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure/post-incubation using a colorimetric test. The reduction of mitochondrial dehydrogenase activity, measured by reduced formazan production after incubation with a tetrazolium salt (MTT) was chosen as endpoint. The formazan production in the test item treated epidermal tissues is compared to that of negative control tissues (relative tissue viability). The negative control material was sterile de-ionized water. The irritation potential of the test item is predicted from the mean relative tissue viabilities compared to the negative control tissues concurrently treated with sterile water. A chemical is considered as "irritant", if the mean relative tissue viability with a test material is less than or equal to 50%. At present no prediction is performed if the mean relative tissue viability with a test material is > 50 ≤ 60% as the cut off value is currently being evaluated to lie in this range. A chemical is considered as "non-irritant", if the mean relative tissue viability with a test material is > 60%. The mean relative viability was 3% for Plantapon LGC Sorb. Thus, the test item showed an eye irritation potential in the EpiOcular™ eye irritation test under the test conditions chosen.

Based on the results of the assays, a risk for Plantapon LGC Sorb to result in serious eye damages cannot fully be excluded. Furthermore, the test method according to the regulatory accepted protocol at the time of reporting does not allow for the evaluation of eye irritation. For final assignment of a risk phrase at present, results from the following in vivo study are to be considered.

In an in vivo study conducted according to the OECD TG 405, 3 female albino rabbits were exposed to 0.1 mL of the test item in one eye (C0201045 -0, 2002). The eyes were examined and the changes were graded according to a numerical scale 1 hour, 24 hours, 48 hours and 72 hours as well as 7 and 14 days after dosing. Well-defined signs of irritation were observed in the treated eyes. All effects were fully reversible within 14 days. The following mean values, based on the results from the 24, 48 and 72 hour-readings were calculated:

- Cornea opacity: 0.7 (1.0 after instillation of fluorescein)

- Iris lesion: 0.7

- Redness of conjunctiva: 2.0

- Chemosis: 1.4

Based on the scores obtained from this in vivo study, the test item is considered to be an irritant to the eye of rabbit under the test conditions used.

Justification for selection of skin irritation / corrosion endpoint:
in vitro assay conducted with Plantapon LGC Sorb (aqueous prep. containing 31.1% a.i.) according to current guidelines (OECD TG 431 and 439), under GLP conditions.

Justification for selection of eye irritation endpoint:
valid in vivo guideline study (OECD 405) conducted under GLP conditions.

Effects on eye irritation: irritating

Justification for classification or non-classification

Based on the available in vitro and in vivo data, the test item needs to be classified for the eye as follows:

Xi R36 according to the EU Directive 67/548/EEC;

Cat 2 (H319) for the eye according to the CLP Regulation (EC)/1272/2008.