Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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: 402-420-3 | CAS number: 89157-03-9
Endpoint summary
Administrative data
Description of key information
The test substance is not a skin sensitizer.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1988/89
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- number of animals
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study was already available
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: HOECHST AG, Kastengrund
- Weight at study initiation: 232 g mean weight
- Housing: 5/cage
- Diet (ad libitum): Altromin 3112
- Water (ad libitum): tap water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 50 ± 20 %
- Air changes (per hr): -
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 25.10.1988 To: 18.11.1988 - Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 1% / 4 * 0.1 mL
- Day(s)/duration:
- Day 1 / single injections
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 25 % / 0.5 mL
- Day(s)/duration:
- Day 9 for 48 h
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 25% / 0.5 mL
- Day(s)/duration:
- Day 22 for 24 h
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Number of animals in test group: 20
Number of animals in negative control group: 10
Number of animals in challenge control group: 5 - Challenge controls:
- 5 animals, challenge treatment on Day 14 for 24 h
- Positive control substance(s):
- yes
- Remarks:
- bi-annual test for validity of test system
- Positive control results:
- valid in bi-annual testing
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- mean skin thickness: 0.83; 4/5 acanthosis grade 1; 2/5 mononuclear infiltration grade 1
- Remarks on result:
- other: Since any skin reaction which may have been present could not be determined visually due to the colour of the test substance itself, the evaluation was performed by means of measurement of the skin thickness and histopathological assessment of the skin.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- mean skin thickness: 0.78; 0/5 acanthosis; 0/5 mononuclear infiltration
- Remarks on result:
- other: Since any skin reaction which may have been present could not be determined visually due to the colour of the test substance itself, the evaluation was performed by means of measurement of the skin thickness and histopathological assessment of the skin.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- mean skin thickness: 0.76; 8/10 acanthosis grade 1; 6/10 mononuclear infiltration grade 1, 1/10 mononuclear infiltration grade 2
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Since any skin reaction which may have been present could not be determined visually due to the colour of the test substance itself, the evaluation was performed by means of measurement of the skin thickness and histopathological assessment of the skin.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- mean skin thickness: 0.71; 0/10 acanthosis; 0/10 mononuclear infiltration
- Remarks on result:
- other: Since any skin reaction which may have been present could not be determined visually due to the colour of the test substance itself, the evaluation was performed by means of measurement of the skin thickness and histopathological assessment of the skin.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- mean skin thickness: 0.83; 0/5 acanthosis; 3/5 mononuclear infiltration grade 1
- Remarks on result:
- other: Since any skin reaction which may have been present could not be determined visually due to the colour of the test substance itself, the evaluation was performed by means of measurement of the skin thickness and histopathological assessment of the skin.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- mean skin thickness: 0.78; 0/5 acanthosis; 0/5 mononuclear infiltration
- Remarks on result:
- other: Since any skin reaction which may have been present could not be determined visually due to the colour of the test substance itself, the evaluation was performed by means of measurement of the skin thickness and histopathological assessment of the skin.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- mean skin thickness: 0.73; 8/10 acanthosis grade 1; 5/10 mononuclear infiltration grade 1, 1/10 mononuclear infiltration grade 2
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Since any skin reaction which may have been present could not be determined visually due to the colour of the test substance itself, the evaluation was performed by means of measurement of the skin thickness and histopathological assessment of the skin.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- mean skin thickness: 0.73; 0/10 acanthosis; 0/10 mononuclear infiltration
- Remarks on result:
- other: Since any skin reaction which may have been present could not be determined visually due to the colour of the test substance itself, the evaluation was performed by means of measurement of the skin thickness and histopathological assessment of the skin.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Reactiv-Red F52 167 FW, based on this expermient, is not a sensitizer
- Executive summary:
The potential of sensitisation of Reactive Red F-52 167 FW was tested on the skin of Pirbright-White-Guinea pigs.
The intradermal Induction treatment was done with 1% of the test substance in 0.9% NaCl-solution. The dermal induction treatment was done with 25% test substance and 0.9% NaCl-solutions.
Since any skin reaction which may have been present could not be determined visually due to the colour of the test
substance itself, the evaluation was performed by means of measurement of the skin thickness and hstopathological assessment of the skin..Evaluation of the study results lead to the conclusion that the test substance is not a sensitizer.
Reactive Red F-52 167 FW, has not to be classified.
Reference
Other observations:
After the challenge treatment two out of 20 animals from the treatment
group exhibited a slightly greater infiltration of the corium compared
with the control animals.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The potential of sensitisation of Reactive Red F-52 167 FW was tested on the skin of Pirbright-White-Guinea pigs.
The intradermal Induction treatment was done with 1% of the test substance in 0.9% NaCl-solution. The dermal induction treatment was done with 25% test substance and 0.9% NaCl-solutions.
Since any skin reaction which may have been present could not be determined visually due to the colour of the test substance itself, the evaluation was performed by means of measurement of the skin thickness and histopathological assessment of the treated skin..
Evaluation of the study results lead to the conclusion that the test substance is not a sensitizer.
Reactive Red F-52 167 FW, has not to be classified.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
no sensitizing effect, no classification necessary
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.
