Blue MOP 6314

Endpoint summary

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:

Primary skin irritation/corrosion study in the rabbit (4-hour semi-occlusive application).

The study was carried out based on the guidelines described in: EC Commission Directive 92/69/EEC, B.4, "Acute Toxicity - Skin irritation" and OECD No.404, “Acute Dermal Irritation/Corrosion".

Three rabbits were exposed to 0.5 grams of test item, applied onto clipped skin for 4 hours using a semi-occlusive dressing. Observations were made 1, 24, 48 and 72 hours after exposure.

Exposure resulted in very slight erythema in the treated skin-areas of the rabbits, which had resolved within 24 hours in all animals.

Blue and blue/green staining of the treated skin by the test substance was observed in all animals throughout the study period, which did not hamper the scoring of the skin reactions.

Based on the results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commission Directive 93/21/EEC), the substance does not have to be classified and has no obligatory labelling requirement for skin irritation.

EYE IRRITATION:

The study was carried out based on the guidelines described in: EC Commission Directive 92/69/EEC, B.5, "Acute Toxicity - Eye irritation" and OECD No.405, "Acute Eye Irritation/Corrosion.

Single samples of approximately 90 mg (a volume of approximately 0.1 ml) were instilled into one eye of each of three rabbits. Observations were made 1, 24, 48 and 72 hours and 7 and 14 days after instillation.

Instillation of the test substance resulted in effects on the cornea, iris and conjunctivae.

Corneal injury was seen as opacity (maximum grade 1) and epithelial damage (maximum 25 %

of the corneal area). The corneal injury had resolved within 72 hours in one animal and within 7 days in the other two animals.

lridial irritation (grade 1) had resolved within 48 hours in two animals and within 72 hours in the other animal.

Irritation of the conjunctivae was seen as redness, chemosis and discharge, which had completely resolved within 14 days in all animals.

One hour after dosing, scoring of redness of the conjunctivae and assessing irritation of a part of the iris was impossible in all animals due to blue staining by the test substance. One and two days after dosing, scoring of redness of the lower part of the eyelids was impossible in all animals due to blue staining by the test substance.

Blue staining of the fur on the head and paws, caused by the test substance, was noted during the observation period.

Based on these results and according to the EC criteria for classification and labelling requirements for dangerous substancesand preparations (Guidelines in Commission Directive 93/21/EEC), the substance should be labelled as: eye irritant cat 2.

Justification for classification or non-classification

According to the CLP Regulation (EC n. 1272/2008), skin Irritation means the production of reversible damage to the skin following the application of a test substance for up to 4 hours.

The substance shows a very low interaction between with the rabbit skin. The values of erythema and oedema are below the trigger values for classification, therefore no classification is warranted according to the CLP Regulation (EC 1272/2008).

According to the CLP Regulation (EC n. 1272/2008) eye irritation means the production of changes in the eye following the application of test substance to the anterior surface of the eye, which are fully reversible within 21 days of application.

The substance is capable to cause conjunctival rednesse above the trigger value for classification, therefore the substance is classified as eye irritant category 2 according to the CLP Regulation (EC 1272/2008).