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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

not skin irritant
eye irritant

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 for skin and eye irritation following OECD 404 and 405 respectively (NONS dossier, 1999. In vivo results are available showing no irritating potential for skin. However, for the eye irreversible discolouration of the conjunctiva and sclera classify as eye irritant the substance.

Based on the read across considerations the same results apply to Reactive Orange 12:1.

Effects on eye irritation: highly irritating

Justification for classification or non-classification

Under Regulation 1272/2008:

a substance is classified as skin irritant Cat 2:

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; or

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.


A substance is classified as:

Eye irritant Cat 1:

If, when applied to the eye of an animal, a substance produces:

at least in one animal effects on the cornea, iris or conjunctiva that are not expected to

reverse or have not fully reversed within an observation period of normally 21 days;


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

corneal opacity3 and/or

iritis > 1,5

calculated as the mean scores following grading at 24, 48 and 72 hours after installation of

the test material.

Based on the results of the in vivo studies performed on the analogue substance and the read across considerations, the substance is not classified for skin but it is classified for eye irritation, cat 1.