Registration Dossier
Registration Dossier
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EC number: 303-757-8 | CAS number: 94213-53-3
Endpoint summary
Administrative data
Description of key information
Not skin irritant
Eye irritant (Category 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
There is no information about the irritation/corrosion potential of Direct Violet 051, therefore, the available data on structural analogous Similar Substance 01 have been taken into account. The read across approach can be considered as reliable and adequate for the purpose; details and explanations are detailed in the report attached to the IUCLID section 13.
Skin irritation/corrosion
In the key study, carried out on Similar Substance 01, the substance was tested in the EpiDerm™ Human Skin Model using duplicate tissues during 3 and 60 minutes. Additional controls were included to account for direct MTT interference and color interference. The relative mean viability of the test substance treated tissues was 102.6 % for the 3 minutes exposure and 96.3% for the 60 minutes exposure. Therefore it can be concluded that the substance is not corrosive to the skin.
The substance was tested in the EPISKIN™ Reconstructed Human Epidermis Model using triplicate tissues during 15 minutes. Additional controls were included to account for direct MTT interference and color interference. The relative mean viability of the test substance treated tissues was 59.8 %. Therefore it can be concluded that the substance is not irritant to the skin.
Two studies carried out on the Target Substance are available and were considered as supporting studies, since the test materials used in both cases were characterized by a low content of Target Substance. The result obtained in one of this two studes, confirmed the outcome of the in vitro tests on the Similar Substance 01. The second one shown a slight irritation potential, however, due to the nature of the test material it can not be concluded that this effect is due to the Target Substance or to other components.
Eye irritation/corrosion
In a BCOP assay bovine corneas were exposed to the substance and assessed for opacity and permeability. Opacity was strongly increased, while permeability was slightly increased compared to the negative controls. The calculation of the In Vitro Irritancy Score showed that the substance is severely damaging to the eyes. As it could not be excluded that staining of the cornea could have influenced the opacity readings, semi-quantitative histopathological evaluation of the corneas from eyes exposed to the substance was performed. This investigation gave scores below the threshold for classification of this material as Eye Category 1. Therefore the conclusion of the study is that the substance is not considered severely damaging to the eyes.
The eye irritation potential of the substance was assessed by means of the Human Cornea Model Test (OECD 492).
The substance proved to be an MTT reducer and interfered with color. Therefore additional controls,viable tissues without MTT addition and freeze-killed tissues were included.The mean relative absorbance value of the test item, corresponding to the cell viability, decreased to 9.7% (threshold for irritancy:≤60%), consequently the test item was irritant to eye.
Two supporting studies carried out on the Target Substance gave a negative result in both cases. However the information coming from this two studies is not sufficient for classification purposes as the content of test item in the substance tested is low.
Justification for classification or non-classification
Based on the results of the available studies, it can be concluded that the substance does not need to be classified for irritation to skin according to Regulation (EC) No 1272/2008 (CLP), but it is considered an eye-irritant and needs to be classified as H319 (category 2).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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