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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 946-373-1 | CAS number: 82941-24-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- other: read across from similar substance
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- Reliability 4 has been assigned due to the lack of information on the composition of test substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
- Principles of method if other than guideline:
- Based on: Federal Register 38 no. 187, 1550.41 (skin), S. 27019, 27.09.73
- GLP compliance:
- no
Test material
- Reference substance name:
- [4-[[4-anilino-1-naphthyl][4-(dimethylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride
- EC Number:
- 219-943-6
- EC Name:
- [4-[[4-anilino-1-naphthyl][4-(dimethylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride
- Cas Number:
- 2580-56-5
- Molecular formula:
- C33H32ClN3
- IUPAC Name:
- [4-[[4-anilino-1-naphthyl][4-(dimethylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rabbit
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 3-4 kg
- Housing: stainless steel cages without litter
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: > 3 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 1 °C
- Humidity: 55 ± 10 %
- Photoperiod: 12 h light / 12 h dark
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- yes
- Amount / concentration applied:
- 0.5 g for solid substances at 50 % in water.
- Duration of treatment / exposure:
- 24 h
- Observation period:
- After 24 h and 72 h. In case of findings at 72 h, additional reading after 7 d.
- Number of animals:
- 6 per group.
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm × 2.5 cm
- Type of wrap if used: gauze, fixed by elastic bandage then PVC-film
REMOVAL OF TEST SUBSTANCE
- Washing: with warm water or Lutrol 400 / water mixture.
- Time after start of exposure: 24 h
SCORING SYSTEM:
Erythema and eschar formation
0 no erythema
1 very slight erythema (barely perceptible)
2 well defined erythema
3 moderate to severe erythema
4 severe erythema (beef redness) to slight eschar formation (injuries in depth)
Edema formation
0 no edema
1 very slight edema (barely perceptible)
2 slight edema (edges of area well defined by definite raising)
3 moderate edema (raised approximately 1 mm)
4 severe edema (raised more than 1 mm and extending beyond area of exposure)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 and 72 h
- Remarks on result:
- not determinable
- Remarks:
- due to staining
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 and 72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
| rating grades | time after application | skin irritation | |||||
| animal | |||||||
| 1 | 2 | 3 | 4 | 5 | 6 | ||
| erythema/eschar | 24 | * | * | * | * | * | * |
| 72 | * | * | * | * | * | * | |
| oedema | 24 | 0 | 0 | 0 | 0 | 0 | 0 |
| 72 | 0 | 0 | 0 | 0 | 0 | 0 | |
Evaluation of erythema was not possible due to staining; no oedema formation occurred.
Applicant's summary and conclusion
- Interpretation of results:
- other: non irritant according to the CLP Regulation (EC 1272/2008)
- Conclusions:
- Non irritant to the skin of rabbits.
- Executive summary:
Method
A study on 6 rabbits was conducted to assess skin irritation potential of test substance, by application of 0.5 g of test substance in water on clipped intact skin. Untreated skin served as control. After 24 h of exposure, skin was washed with water; assessment for erythema and oedema formation was carried out 24 and 72 h after removal according to Draize scale.
Results
Erythema could not be assessed due to staining; no signs of oedema were visible in any of the rabbits.
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.
