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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Based on the available information, the test item is determined as a non-irritant for the eye or the skin.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Please refer to the read-across justification attached to section 13.
Reason / purpose for cross-reference:
read-across source
Irritation parameter:
erythema score
Basis:
animal: all
Time point:
24 h
Score:
0
Max. score:
4
Remarks on result:
other: Result read-across source CAS No. 12237-23-9
Irritation parameter:
edema score
Basis:
animal: all
Time point:
24 h
Score:
0
Max. score:
4
Remarks on result:
other: Result read-across source CAS No. 12237-23-9
Irritation parameter:
erythema score
Basis:
animal: all
Time point:
72 h
Score:
0
Max. score:
4
Remarks on result:
other: Result read-across source CAS No. 12237-23-9
Irritation parameter:
edema score
Basis:
animal: all
Time point:
72 h
Score:
0
Max. score:
4
Remarks on result:
other: Result read-across source CAS No. 12237-23-9
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24/72h
Score:
0
Remarks on result:
no indication of irritation
Remarks:
Result read-across source CAS No. 12237-23-9
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Please refer to the read-across justification attached to section 13.
Reason / purpose for cross-reference:
read-across source
Irritation parameter:
cornea opacity score
Basis:
animal: all
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: Result read-across source CAS No. 12237-23-9
Irritation parameter:
iris score
Basis:
animal: all
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
other: Result read-across source CAS No. 12237-23-9
Irritation parameter:
conjunctivae score
Basis:
animal: all
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
other: Result read-across source CAS No. 12237-23-9
Irritation parameter:
chemosis score
Basis:
animal: all
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: Result read-across source CAS No. 12237-23-9
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

As no studies are available with the test substance itself a read-across is made to a a structural analogue of the substance.

Skin irritation / corrosion (Orasol Black CN, CAS 12237-23-9)

The test item was assessed using the animal test according to the principles of "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO). English Silver rabbits (3 males, 3 females) were tested under occlusive conditions using plastic film, after they were shaved. The amount of the test item which was applied on the back of the rabbits was 0.5 g at each side, using 50% polyethylene glycol suspension as vehicle.A gauze patch 2.5 x 2.5 cm was soaked with the test item and immediately applied to the prepared skin. The patch was covered with a plastic film 5 x 5 cm, which was fixed to the body with adhesive tape. The gauze patches were removed 24 h after the application. The reaction of the skin was appraised upon removal and 72 h after it.The primary irritation index as the measure of the acute irritation to the skin of rabbits was found to be 0 based on the scoring system of the protocol employed. Therefore, the test item is determined to be non-irritant to the skin of rabbits (Ciba-Geigy Ltd, 1972).

 

Eye irritation (Orasol Black CN, CAS 12237-23-9)

The test item was assessed using the technique described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO). The test item was tested on 6 rabbits (3 males/3 females) of the English Silver strain, which were kept separately in V2A wire cages and fed on NAFAG, Gossau SG, rabbit food and water ad libitum. Only rabbits showing normal ophthalmic findings were included in the test. Amounts of 0.1 g. of the test item were introduced into the conjunctival sac of the left eye with a spatula. After application, the eyelids were held open for a few seconds. The right eye served as a control. The treated eyes of three rabbits were each rinsed with 10 mL. lukewarm water about 30 seconds after treatment. The reactions were appraised with a slit-lamp after 24 h and after 2, 3, 4 and 7 days on the basis of the protocol employed. The primary-irritation index, which serves as a measure of the acute irritation provoked by the test item, was found to be 0 for the cornea, 0 for the iris and 0 for the conjunctivae. Therefore, the test item is determined to be a non-Irritant to the eye of rabbits (Ciba-Geigy Ltd, 1972).

Justification for classification or non-classification

Based on the available data classification and labelling for skin and eye irritation is not warranted in accordance with EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008