Registration Dossier

Administrative data

Description of key information

Studies on read across substances showed:

- no skin irritation

- serious eye damage/irreversible adverse effects

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

No experimental data on target substance was available, thus available data on different salifications, i.e. Similar Substance 01 and 02, was used as read across. Details on the read across approach are available in section 13.

The skin irritation potential was examined in 2 tests on Similar Substance 01 (1989 and 1984) and one test on Similar Substance 02 (1984).

In all studies, test substance was applied for 4 hours in a semiocclusive manner to the skin of 3 rabbits. Animals were observed for up to day 7 upon exposure; oedema and erythema scores were recorded 24 h, 48 h, 72 h and 7 d after patch removal. In both the supporting studies (1984), erythema could not be assessed due to blue colour of skin.

No signs of local irritation were reported and skin of 3/3 animals gave the following mean reaction scores (24, 48 and 72 h): erythema score = 0 (when available) and oedema score = 0.

The eye irritation potential of test substance was examined in 3 tests (1989, 1984, 1984), using the same test materials as in skin irritation studies.

In the key study (1989), Similar Substance 01 was applied to the eye of one rabbit for 24 h, then the eye was rinsed. After an observation period of 72 h, effects were considered as irreversible and the animal was killed. Mean irritation indices (at 24, 48 and 72 h) for 1/1 animal were as follows: cornea = 2.7, iris = 4 and conjunctivae = 3.

In a supporting study (1984), 3 rabbits were exposed to Similar Substance 01 for 24 h, then the eye was rinsed. Then, eye reactions were scored at 24 h, 48 h, 72 h, 7 d, 14 d and 21 d after exposure. The mean irritation indices (at 24, 48 and 72 h) for 3/3 animals were the following: cornea 3, iris = 1 and conjuctivae = 3 and these effects were not reversible by 21 days.

In another supporting study (1984), 3 rabbits were exposed to Similar Substance 02 for 24 h, then the eye was rinsed. Then, eye reactions were scored at 24 h, 48 h, 72 h, 7 d, 14 d and 21 d after exposure. The mean irritation indices (at 24, 48 and 72 h) for 3/3 animals were the following: cornea = 2, iris = 1.3 and conjuctivae = 3 and these effects were not reversible by 21 days.

Despite different composition of test material in 3 tests, results were coherent and in agreement. As reactions recorded in all animals were not reversible by 21 days, test substance was considered as able to cause serious eye damage.


Justification for classification or non-classification

Classification criteria for effects on skin and eye upon topical application are reported in the CLP Regulation (EC 1272/2008). A decision on classification was based on available studies reporting:

- no signs of skin irritation, thus mean scores below the threshold for classification, i.e. 2.3

- signs of irreversible eye damage

Therefore, classification as substance that causes serious eye damage, i.e. H318, was applied.