Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 221-423-9 | CAS number: 3089-16-5
Endpoint summary
Administrative data
Description of key information
Skin sensitisation: Read-across, not sensitizing
Respiratory sensitisation: no data available
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Please see the attached justification.
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Parameter:
- SI
- Value:
- < 3
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
4, 11 -Dichloroquinacridone has not been tested for skin sensitisation, but several reliable data are available for other quinacridone pigments (Pigment Violet 19 and Pigments Red 122, 209 and 282).
In a reliable GLP-conform study according to OECD TG 429 (Klimisch score 1), Pigment Violet 19 dissolved in acetone:olive oil, 4:1 (v/v) was assessed for its possible contact allergenic potential. For this purpose, a local lymph node assay was performed in CBA mice (4 females per group) using test item concentrations of 5, 10 and 20 % (w/v). The animals did not show any clinical signs during the course of the study and no cases of mortality were observed. Stimulation indices of 2.1, 1.8 and 1.6 were determined. A EC3 value could not be determined. The positive control substance was sensitising (EC value 9.9 %), thus confirming the validity of the tests system.
In a reliable GLP-conform study according to OECD TG 429 (Klimisch score 1), Pigment Red 122 dissolved in acetone:olive oil, 4:1 (v/v) was assessed for its possible contact allergenic potential. For this purpose, a local lymph node assay was performed in CBA mice (4 females per group) using test item concentrations of 5, 10 and 25 % (w/w). The animals did not show any clinical signs during the course of the study and no cases of mortality were observed. Stimulation indices of 1.11, 0.61 and 0.5 were determined. A EC3 value could not be determined. The positive control substance was sensitising (SI value 5.06), thus confirming the validity of the tests system.
In a reliable study according to OECD TG 429 (Klimisch score 1), Pigment Red 209 dissolved in acetone:olive oil, 4:1 (v/v) was assessed for its possible contact allergenic potential. For this purpose, a local lymph node assay was performed in CBA mice (4 females per group) using test item concentrations of 1, 5 and 10 % (w/w). The animals did not show any clinical signs during the course of the study and no cases of mortality were observed. Stimulation indices of 2.4, 2.0 and 1.6 were determined. A EC3 value could not be determined. The positive control substance was sensitising (EC3 value 11.3 %), thus confirming the validity of the tests system.
In a reliable GLP-conform study according to OECD TG 429 (Klimisch score 1), Pigment Red 282 dissolved in ethanol:water, 7:3 (v/v) was assessed for its possible contact allergenic potential. For this purpose, a local lymph node assay was performed in CBA mice (4 females per group) using test item concentrations of 2.5, 5 and 10 % (w/w). All treated animals survived the scheduled study period. No clinical signs were observed in any animals of the control group or Group 2 (2.5 %). On the second application day, a slight ear swelling was observed at both dosing sites in all mice of Group 3 (5 %) and Group 4 (10 %), persisting for a total of four days. For one animal of the high dose group the sign persisted for the remainder of the in-life phase of the study. Stimulation Indices of 0.8, 1.4 and 1.1 were observed.
Several supporting studies (including guinea pig maximisation tests) and secondary sources from literature confirm these findings.
Therefore, it is concluded that Quinacridone Pigments are not sensitising to skin and have not to be classified for skin sensitisation.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. No increase in the stimulation index was observed in the LLNA (OECD 429) and negative results in the guinea pig maximisation test (OECD 406) could be derived for related quinacridone pigments. Therefore, the substance does not require classification as a skin sensitizer under Regulation (EC) No. 1272/2008, as amended for the 17th time in Regulation (EC) No. 2021/849.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
