Registration Dossier

Administrative data

Description of key information

Not a skin irritatant or a skin corrosive

Category 1 - Serious Eye Damage

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 (irreversible damage)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation/corrosion

Skin irritation potential of the test item was evaluated in an in vivo experimental study performed according to the OECD Guideline 404 (1987) and EU method B.4 (1984). 0.5 g of moistened, solid test item was applied to the shaved, dorsal area of three rabbits for a duration of 4 hours. Observations of irritation (erythema and oedema scores; maximum score: 4) and corrosion (local destruction or corrosion) were recorded 1, 24, 48 and 72 hours after removal of the bandage. Animals were monitored for local discolouration (daily), toxic symptoms (daily) and body weight (end of study period).

Irritation scores (mean scores of 24, 48 and 72 hours) were 0 for both erythema and oedema for all animals. In the area of application, slight black staining of the treated skin by pigment or colouring of the test item was observed in 2 animals and was reversible within 24 hours. No corrosive effect, toxic symptoms or significant body weight differences were observed.

Eye irritation/corrosion

Eye irritation potential of the test item was evaluated in an in vivo experimental study performed according to the OECD Guideline 405 (1987) and EU method B.5 (1984). 0.1 g of undiluted, solid test item was administered to the left conjunctival sac of three female rabbits and was not rinsed. Irritation scores for corneal capacity (maximum: 4), iritis (maximum: 2), conjunctival redness (maximum: 3) and chemosis (maximum: 4) were recorded 1, 24, 48 and 72 hours and 7 and 14 days after application, and irritation scores for each parameter were calculated as mean of irritation scores at 24, 48 and 72 hours. Animals were also monitored for toxic symptoms, mortality, local discolouration and body weight change.

No mortality or symptoms of toxicity were observed during the study period. Body weights of all three animals did not differ significantly. Corneal opacity score was 1 for all animals. Iritis score was 0 for all animals. Conjunctival redness scores were 1, 1.67 and 0 for animals #1, #2 and #3, respectively. Chemosis scores were 0.67, 1.33 and 1 for animals #1, #2 and #3, respectively. All four irritation effects were reversible within the study period (14 days). In the area of application, a slight black staining of the cornea, lidhairs and conjunctivae by pigment or colouring from the test item was observed and persisted until the end of the study period (14 days), and reversibility was not possible to be demonstrated.

Justification for classification or non-classification

Skin Irritation/Corrosion

According to the CLP criteria (EC) no. 1272/2008 for skin corrosion and irritation a substance is classified as a Category 1: Skin Corrosive if it produces irreversible damage to the skin, namely, visible necrosis through the epidermis and into the dermis, in at least 1 test animal following the application of a test item for up to 4 hours. Corrosive reactions are typified by ulcers, bleeding, bloody scabs, discolouration due to blanching of the skin after 14 days, complete areas of alopecia, and scars. Skin corrosives can be further divided into 3 sub-categories:

- Sub-Category 1A: corrosive responses in at least one animal following exposure ≤ 3 min during an observation period ≤ 1 h  

- Sub-Category 1B: corrosive responses in at least one animal following exposure > 3 min and ≤ 1 h and observations ≤ 14 days  

- Sub-Category 1C: corrosive responses in at least one animal after exposures > 1 h and ≤ 4 h and observations ≤ 14 days 

A substance is classified as Category 2: Skin Irritant if:  

(i) it produces reversible damage (mean score of ≥ 2.3 and ≤ 4.0 for erythema and/or oedema at 24, 48 and 72 hours after removal) following the application of a test substance for  4 hours in at least 2 of 3 tested animals; or  

(ii) it produces inflammation that persists to the end of an observation period of 14 days in at least 2 animals, particularly taking into account alopecia (limited area), hyperkeratosis, hyperplasia, and scaling; or 

(iii) very definite positive effects related to chemical exposure are apparent in a single animal but it does not meet the criteria above. 

According to the study available, the mean irritation scores for the test item do not satisfy the abovementioned criteria for Category 1: Skin Corrosive or Category 2: Skin Irritant.

Eye Irritation/Corrosion Criteria  

According to the CLP criteria (EC) no. 1272/2008 for serious eye damage and eye irritation, a substance is classified as Category 1: Serious Eye Damage if it produces (i) effects on the cornea, iris or conjunctiva which are not reversible within 21 days in at least one animal, and/or (ii) a positive response of corneal opacity (mean score ≥ 3) or iritis (mean score > 1.5) in at least 2 of 3 animals, following grading at 24, 48 and 72 hours after application of the test material to the anterior surface of the eye  

A substance is classified as Category 2: Eye Irritant if it produces a positive response of corneal opacity (mean score 1), iritis (mean score 1), conjunctival redness (mean score 2) and/or chemosis (mean score 2) in at least 2 of 3 animals following grading at 24, 48 and 72 hours after application of the test material to the anterior surface of the eye which is fully reversed within 21 days  

Considering the in vivo experimental results available, corneal opacity scores met the criteria for Category 2: Eye Irritant. All irritation effects were reversible within the 14-day study period. On the other hand, reversibility of the discolouration was not observed within the 14-day study period. It is not possible to define whether the corneal discolouration would be reversible within 21 days, therefore, the worst case approach is applied and the effect is considered not reversible, as stated in the criteria for Category 1. Moreover, the substance has a harmonised classification in Annex VI of the CLP Regulation (EC) no. 1272/2008 as Category 1. Therefore, the classification of the substance as Category 1: Serious Eye Damage is warranted.