Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

skin irritation, rabbit, semiocclusive, not irritating

eye irritation, rabbits, irritating, H310 Eye irritation 2

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

The analogue substance was tested in two in-vivo studies for skin and eye irritation folloiwng EU Method B4 and B5 (1989).

Justification for classification or non-classification

According to the CLP Regulation (EC n. 1272/2008) the following classifications apply:

 

Skin irritant cat2:

1) Mean value of ≥ 2,3 - ≤ 4,0 for erythema/ eschar or for oedema in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours after patch removal or, if reactions are delayed, from grades on 3 consecutive days after the onset of skin reactions; or

2)Inflammation that persists to the end of the observation period normally 14 days in at least 2 animals, particularly taking into account alopecia (limited area), hyperkeratosis, hyperplasia, and scaling; o

3) In some cases where there is pronounced variability of response among animals, with very definite positive effects related to chemical exposure in a single animal but less than the criteria above.

 

 

Eye irritant Cat 2:

at least in 2 of 3 tested animals, a positive response of:

1)     corneal opacity ≥ 1 and/or

2)     iritis ≥ 1, and/or

3)      conjunctival redness ≥ 2 and/or

4)      conjunctival oedema (chemosis) ≥ 2

calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material, and which fully reverses within an observation period of 21 days.

Based on the results of the in vivo eye irritation, the substance is classified as H319, Eye Irritation 2.