Diammonio(ethyl)[4-[[4-[ethyl(3-sulphonatobenzyl)amino]phenyl](2-sulphonatophenyl)methylene]cyclohexa-2,5-dien-1-ylidene](3-sulphonatobenzyl)ammonium

Endpoint summary

Description of key information

Not irritating to skin.

Not irritating to eye.

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:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

The following reported data were obtained for Similar Substance 1. It is expected that the Target substance will present similar effect levels of skin irritation/corrosion and eye irritation. Justification for Read Across is given in

Section 13 of IUCLID.

Eye Irritation

Eye irritation was tested in study following OECD testing guideline 405. This study did not have GLP status. The test material was an aqueous formulation of 38% content. The guideline requires testing 0.1 ml or 0.1g of a substance. In this case, the relative density of 1.48 and the bulk density of 500 kg/m3 indicates that the volume unit of 0.1 ml is the appropriate dose. It corresponds to ca. 50 mg of the pure, solid test substance. In contrast, the amount applied via the aqueous formulation was 38 mg.

This difference in the amount tested is considered negligible because the already dissolved substance represents a more direct exposure and because the findings were clearly below threshold of classification. Regard the criteria for classification and labelling of GHS, the outcome would not have been different if 50 instead of 38 mg would have been tested. This study therefore is suitable as key study.

The substance resulted in transient blue coloration of the eye and in slight reversible redness and swelling of conjunctivae. Due to the intense blue staining, iris and cornea scores could not be determined at the 1h and 24h reading. Examination with fluorescein on day 8 did not show any adverse findings. The slight findings observed for this formulation is attributed to the 7% content of oxalic acid present in the tested formulation.

Another eye irritation study in rabbits is available for a dry commercial product that according to the description is or contain Similar Substance 1, however no further proof of identity other than the name is available. Accordingly, this study is assigned a validity score of 4. In this study, a 50% concentrate (described as a dark blue liquid) was also tested. The study followed the procedure that later became the OECD guideline 405, but less details on animal housing and obviously test item are contained in the report. Six New Zealand White rabbits were treated with 0.1 ml or 0.096 mg of the substance and the eyes were scored after 24, 48 and 72 hours. At no point in time, there were adverse effects reported.

Skin irritation

The same test material (38% formulation) as used in the eye irritation study was also used for the skin irritation test in rabbits. The procedure of the test was identical to OECD guideline 404 with the exception that the observation was discontinued after 8 days. Animals were treated with 0.5 mL (ca 190 mg) of the formulation under an occlusive wrapping for 4h. Then the test item was removed with water. The substance resulted in blue staining of the skin which interfered with scoring for erythema. In two animals, staining resolved within 8 days. In the other animal, staining was still visible after 8 days. Edema were not observed at any observation time points. Readings were done 30 - 60 min after removal of the test patches as well as 24 h, 48 h, 72 h and 8 d after application.

As discussed for the eye irritation study, the applied amount is lower than the amount prescribed in the OECD guideline. However, since there was no indication of skin irritation, this difference in amounts has no impact on the classification and labelling under GHS.

Another skin irritation study in rabbits is available for a dry commercial product that according to the description is or contain Similar Substance 1, however no further proof of identity other than the name is available

. Accordingly, this study is assigned a validity score of 4. In this study, a 50% concentrate (described as a dark blue liquid) was also tested in addition to the pure solid. The study followed the US EPA OPP 81-5 guideline on acute dermal irritation which is a more stringent protocol than the OECD guideline: The exposure duration was 24h and both intact and abraded skin sites were treated. In general, less details on animal housing and obviously the test item are contained in the report. Six New Zealand White rabbits were treated with 0.5g of the substance in an occlusive wrapping and the skin were scored after 24 and 72 hours. Very sliqht erytherna was noted at one intact site and one abraded site at the 24-hour reading of one animal. The five other animals showed no skin reactions. The rabbit with slight skin reactions showed no reactions at intact skin site at the 72- hour reading and very slight erythema was noted at one abraded site. The absence of a skin reaction triggering classification and labelling according to GHS criteria is confirmed in this study.

Justification for classification or non-classification

SKIN IRRITATION/CORROSION

According to the CLP Regulation (EC 1272/2008) substances that have the potential to induce reversible damage to the skin following the application of a test substance for up to 4 hours are classified in Category 2 (irritating to the skin) if:

-mean value of ≥ 2.3 ≤ 4.0 for erythema/eschar or for oedema in at least 2 of 3 (or 4 out of 6) tested animals from gradings at 24, 48 and 72 h after patch removal or, if reactions are delayed, from grades on 3 consecutive days after the onset of skin reactions; or

-inflammation that persists to the end of the observation period normally 14 d in at least 2 animals, particularly taking into account alopecia (limited area), hyperkeratosis, hyperplasia, and scaling; or

-in some cases where there is pronounced variability of response among animals, with very definite positive effects related to chemical exposure in a single animal but less than the criteria above.

 

Based on the results obtained the mean score (24/48/72h) of erythema and edema was not in the range of ≥ 2.3 - ≤ 4.0; therefore the substance is not classified for skin irritation according to the CLP Regulation (EC 1272/2008).

 

EYE IRRITATION

According to the CLP Regulation (EC 1272/2008) substances that have the potential to seriously damage the eyes are classified in Category 1 (irreversible effects on the eye) if, when applied to the eye of an animal, a substance produces:

- at least in one animal effects on the cornea, iris or conjunctiva that are not expected to reverse or have not fully reversed within an observation period of normally 21 days; and/ or

- at least in 2 of 3 tested animals, a positive response of: corneal opacity ≥ 3 and/or iritis > 1,5

calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material.

Substances that have the potential to induce reversible eye irritation are classified in Category 2 (irritating to eyes) if, when applied to the eye of an animal, a substance produces at least in 2 of 3 tested animals, a positive response of:

-corneal opacity ≥ 1 and/or

-iritis ≥ 1, and/or

-conjunctival redness ≥ 2 and/or

-conjunctival oedema (chemosis) ≥ 2,

calculated as the mean scores following grading at 24, 48 and 72 h after installation of the test material, and which fully reverses within an observation period of 21 d.

 

Based on the results obtained in the eye irritation study performed, for the substance no classification is warranted for Serious eye damage/eye irritation according to the CLP Regulation (EC n. 1272/2008).