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Administrative data

Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin:

A primary skin irritation test was conducted with rabbits to determine the potential for Spectrace® MD-810 Marker (Solvent

Free) to produce irritation after a single topical application.

Five-tenths of a gram of the test substance was moistened with distilled water and applied to the skin of three healthy rabbits

for 4 hours. Following exposure, dermal irritation was evaluated by the method of Draize et al.

All animals appeared active and healthy. There were no other signs of gross toxicity, adverse pharmacologic effects or abnormal behavior. There was no edema observed at any treated site during this study. One hour after patch removal, all three treated sites

exhibited very slight erythema. All animals were free of dermal irritation by 24 hours. The Primary Dermal Irritation Index (PDII) calculated for this test substance was 0.3.

Eye:

A primary eye irritation test was conducted with rabbits to determine the potential for Spectrace® MD-8 10 Marker

(Solvent Free) to produce irritation from a single instillation via the ocular route. Under the conditions of this study,

the observed ocular effects of Spectrace® MD-810 Marker (Solvent Free) were slight irritation to the eye.

Prior to its use in the study, the test substance was ground to a fine powder. One-tenth of a milliliter (0.03 grams) of

the ground test substance was instilled into the right eye of three healthy rabbits. The left eye remained untreated

and served as a control. Ocular irritation was evaluated by the method of Draize et al.1. One hour after test substance instillation, all three treated eyes exhibited corneal opacity, iritis, and conjunctivitis. The overall incidence and severity of irritation decreased with time. All animals were free of ocular irritation by 72hours.


Effects on skin irritation/corrosion: slightly irritating

Effects on eye irritation: slightly irritating

Justification for classification or non-classification

Skin:

Under the conditions of this skin irritation study, Spectrace MD-8 10 Marker (Solvent Free) caused only very slight irritation which was resolved by 24 hrs. Therefore, this material would not be classified as a skin irritant under EU GHS criteria.

Eye:

One hour after test substance instillation, all three treated eyes exhibited corneal opacity, intis, and conjunctivitis. The overall incidence and severity of irritation decreased with time. All animals were free of ocular irritation by 72 hours. The Maximum Mean Total Score of Spectracem MD-8 10 Marker (Solvent Free) is 21.3. Slight eye irritation was observed. However, the mean 24, 48, and 72 hour cornea, iris, conjunctivae, and chemosis scores did not rise to the level of classifcation.