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Registration Dossier
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EC number: 270-096-9 | CAS number: 68411-04-1
Endpoint summary
Administrative data
Description of key information
A modified local lymph node assay (IMDS) was performed on 24 female NMRI mice of the strain HsdWin:NMRI (6 animals/test item group and 6 control animals) to determine if there is any specific (sensitising) or non-specific (irritant) stimulating potential of the test item Astra Blau6GLL HSP.
A concurrent control of 6 animals treated with Alpha Hexyl Cinnamic Aldehyde was included.
In the LLNA no antigen specific activation of the cells of the immune system via dermal route was determined after application of up to and including 30% C.I. Direct Blue 264. Therefore, the concentration of 30% turned out to be the NOEL for the parameters investigated in this study with respect to skin sensitization.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guiudeline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Principles of method if other than guideline:
- The modified Local Lymph Node Assay (IMDS) was performed on 24 female NMRI mice of the strain Crl:NMRI BR (6 animals/test item group and 6 control animals) to determine if there is any specific (sensitizing) or non-specific (irritant) stimulating potential of the test item C.I. Direct Blue 264.
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- female
- Vehicle:
- dimethylformamide
- Concentration:
- Group 1 Vehicle (DMF)
Group 2 3% C.I. Direct Blue 264
Group 3 10% C.I. Direct Blue 264
Group 4 30% C.I. Direct Blue 264
Group 5 30% Alpha Hexyl Cinnamic Aldehyde (in DMF) - No. of animals per dose:
- 6 animals/test item group and 6 control animals
- Parameter:
- SI
- Remarks on result:
- other: see Remark
- Remarks:
- A modified Local Lymph Node Assay (IMDS) was carried out in mice. The modifications refer to the measurement of cell proliferation by cell counting instead of radioactive labeling. In addition, the acute inflammatory skin reaction is determined to discriminate specific from non-specific activation of immune competent cells in the draining lymph nodes, as also recommend in the update of OECD TG 429. 1. Direct LLNA (NMRI mice, female, 6 animals/group) Groups Weight index Cell count index (index of mean +/- SD in %) Gr. 1 1.00 +/- 9.70 1.00 +/- 17.40 Gr. 2 1.17 +/- 16.65 1.16 +/- 23.10 Gr. 3 1.22 +/- 7.87 1.37 +/- 15.12 Gr. 4 1.16 +/- 14.77 1.16 +/- 25.40 Gr. 5 1.66 +/- 14.40 1.63 +/- 18.66 2. Ear swelling (NMRI mice, female, 6 animals/group, in 0.01 mm) Groups day 1 day 4 Index day 4 (mean +/- SD in %) Gr. 1 17.42 +/- 2.96 20.00 +/- 7.69 1.00 Gr. 2 17.67 +/- 4.41 19.25 +/- 7.39 0.96 Gr. 3 17.75 +/- 3.50 20.92 +/- 6.59 1.05 Gr. 4 17.58 +/- 2.93 20.92 +/- 13.28 1.05 Gr. 5 17.50 +/- 2.98 24.25 +/- 8.64 1.21 * = statistically significant increase (p< 0.05) 3. Ear weight (NMRI mice, female, 6 animals/group, in mg per 8 mm diameter punch) Groups day 4 Index day 4 (mean +/- SD in %) Gr. 1 13.90 +/- 5.76 1.00 Gr. 2 13.22 +/- 6.87 0.95 Gr. 3 13.58 +/- 6.55 0.98 Gr. 4 14.58 +/- 6.86 1.05 Gr. 5 16.33 +/- 7.45 1.18 * = statistically significant increase (p< 0.05)
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: not applicable
- Parameter:
- SI
- Remarks:
- Cell count index
- Value:
- 1
- Test group / Remarks:
- 6 animals/group
- Remarks on result:
- other: Gr. 1
- Parameter:
- SI
- Remarks:
- Cell count index
- Value:
- 1.16
- Test group / Remarks:
- 6 animals/group
- Remarks on result:
- other: Gr. 2
- Parameter:
- SI
- Remarks:
- Cell coung index
- Value:
- 1.37
- Test group / Remarks:
- 6 animals/group
- Remarks on result:
- other: Gr. 3
- Parameter:
- SI
- Remarks:
- Cell count index
- Value:
- 1.16
- Test group / Remarks:
- 6 animals/group
- Remarks on result:
- other: Gr. 4
- Parameter:
- SI
- Remarks:
- Cell count index
- Value:
- 1.63
- Test group / Remarks:
- 6 animals/group
- Remarks on result:
- other: Gr. 5
- Interpretation of results:
- GHS criteria not met
- Executive summary:
A LLNA/IMDS was carried out in female NMRI mice after epicutaneous application of a formulation containing 0%, 3%, 10% or 30% of the test item C.I. Direct Blue 264 for 3 consecutive days onto both ears of the animals.
This study does neither point to a non-specific (irritant) nor to a specific immunostimulating (sensitizing) potential of the test item.
This applies to NMRI mice, for weight and cell count indices of the draining lymph nodes as well as ear swelling and ear weight indices evaluated after application of C.I. Direct Blue 264.
These findings were verified by the results obtained with the positive control compound Alpha Hexyl Cinnamic Aldehyde.
Taken together, no antigen specific activation of the cells of the immune system via dermal route was determined after application of up to and including 30% C.I. Direct Blue 264 by the method used.
Therefore, the concentration of 30% turned out to be the NOEL for the parameters investigated in this study with respect to skin sensitization.
According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
A LLNA/IMDS was carried out in female NMRI mice after epicutaneous application of a formulation containing 0%, 3%, 10% or 30% of the test item C.I. Direct Blue 264 for 3 consecutive days onto both ears of the animals.
This study does neither point to a non-specific (irritant) nor to a specific immunostimulating (sensitizing) potential of the test item. No antigen specific activation of the cells of the immune system via dermal route was determined after application of up to and including 30% C.I. Direct Blue 264.
Therefore, the concentration of 30% turned out to be the NOEL for the parameters investigated in this study with respect to skin sensitization.
The sensitivity of the test system was verified by results obtained with the positive control compound Alpha Hexyl Cinnamic Aldehyde.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the negative data in the LLNA assay, according to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.
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