Merginol 901

Endpoint summary

Description of key information

Data on skin and eye irritation are available for the substance from well conducted in vivo studies in rabbits. In addition, supporting information is available from an in vitro HET-CAM test for eye irritation. With regard to skin irritation, the test item was considered to be not irritating. Considering eye irritation, the test item was judged to be slightly irritating, but without fulfilling the criteria for classification.

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

Skin irritation/ corrosion of the substance:

The skin irritating toxicity of the test item was assessed in an acute dermal irritation/corrosion test in 3 albino rabbits according to OECD 404, adopted in 1992. In this key study, 0.5 mL of the test item was applied on the right side of the clipped back, the untreated left side served as control. Exposure duration was 4 h. Both sides were examined at 1, 24, 48 and 72 h after the end of exposure and thereafter until reversibility of the findings. Well-defined to very slight erythema and very slight oedema were observed in all animals at 1 h after the 4-hour exposure and disappeared within 4 to 8 days after exposure. No other toxic effects were observed. The mean grades of skin reactions at 24, 28 and 72 h after the end of the exposure were, in the three animals with 1.67, 2.0 and 1.3 for erythema and 0.67 for oedema formation, lower than the value classified as irritant by the EEC Directive 93/21/EEC. Therefore the test item was classified as "non-irritant" when applied to skin (Toxlabs Bioscience GmbH 1998).

 

Eye irritation/ corrosion of the substance

The potential irritating properties of the test item were assessed in an acute eye irritation/corrosion test in albino rabbits according to OECD 405, adopted in 1992. In this key study, 0.1 mL of the test article was introduced into the conjunctival sac of the left eye, the untreated right eye served as control. Both eyes were examined at 1, 24, 48 and 72 h post application. Slight to moderate redness and swelling of the conjunctivae were observed in all animals at 1 h after instillation and disappeared within 48 to 72 h post application. Slight ocular secretion was seen in all animals at 1 h after instillation. Two animals revealed a slight vascular injection on the eyeball at 1 h after treatment. No other toxic effects were observed. The mean grades of ocular reactions at 24, 28 and 72 h post application were in all three animals lower than the value classified as irritant by the EEC Directive 93/21/EEC (cornea score = 0; iris score = 0; chemosis = 0.33; conjunctivae score = 0.33 for animal 1 and 3 and = 0.67 for animal 2). Therefore the test item was classified as "non-irritant” (Toxlabs Bioscience GmbH 1998). This result is confirmed by data from an in vitro study in which the irritating potential of the test item was assessed using the HET-CAM test. Also here, the test item was considered to be not irritating (Henkel 1998).

Justification for classification or non-classification

Based on the available data classification and labeling for skin and eye irritation is not warranted in accordance with EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008