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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 212-658-8 | CAS number: 838-88-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific standards, well documented and acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 959
- Report date:
- 1959
Materials and methods
- Principles of method if other than guideline:
- Suspension of test substance in water, ethanol, and oil (30% w/v) was applied to a 2.5 x 2.5 cm patch (0.5-1 ml) and placed on the clipped and intact skin of two white Vienna rabbits for 1 min, 5 min, 15 min (TS in water and ethanol) and 20 hours (TS in water, ethanol, and oil) under occlusive conditions.
By the end of short-term exposure (1-15 min), the skin was irrigated and skin reaction was recorded up to five days after application of the test substance. Cutaneous reaction were described according to Draize criteria. - GLP compliance:
- no
Test material
- Reference substance name:
- 4,4'-methylenedi-o-toluidine
- EC Number:
- 212-658-8
- EC Name:
- 4,4'-methylenedi-o-toluidine
- Cas Number:
- 838-88-0
- Molecular formula:
- C15H18N2
- IUPAC Name:
- 4-[(4-amino-3-methylphenyl)methyl]-2-methylaniline
- Details on test material:
- - Name of test material (as cited in study report): 4,4´-Diamino-3,3´-dimethyl-diphenylmethan = o-"Toluidinbase", destilled, grinded
- Physical state: crystalline powder, creme-like coloured
- Analytical purity: 99-100%
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- not reported
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: clipped
- Vehicle:
- other: 20 h test: water, ethanol (96%) or oil; time test: water or ethanol (96%)
- Controls:
- no
- Amount / concentration applied:
- Concentration: 30 %
TEST MATERIAL
- Amount(s) applied: ca. 1 mL
- Concentration (if solution): 30% - Duration of treatment / exposure:
- Experiment 1: 1, 5, or 15 minutes
Experiment 2: 20 h - Observation period:
- at least 5 d, until complete recovery
- Number of animals:
- 2 per treatment
- Details on study design:
- TEST SITE
- Area of exposure: An application site of 2.5 X 2.5 cm was covered with the liquid (37°C; approx. 1 ml)
REMOVAL OF TEST SUBSTANCE
- Washing:
Experiment 1: washing was done in the 1 min, 5 min and 15 min test directly after exposure. Lutrol 50% (mild detergent) was used as concentrate, followed by 50% solution in water
Experiment 2: No washing was done after the 20 h treatment.
SCORING SYSTEM: Descriptive scores were converted into Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 20 h exposure, vehicle: water
- Time point:
- other: 24 - 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: yellow staining within the first three days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 20 h exposure, vehicle: ethanol
- Time point:
- other: 24 - 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: yellow staining within the first three days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 20 h exposure, vehicle: oil
- Time point:
- other: 24 - 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: yellow staining within the first three days
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 20 h exposure; all tested vehicles
- Time point:
- other: 24 - 72 h
- Score:
- 0
- Max. score:
- 4
Any other information on results incl. tables
Short time exposure (1-15 min): Independent from the solvent used, no cutaneous reaction was observed at the end of the exposure period.
Long time exposure (20 hours): Test substance caused yellowish skin coloration perceptible for up to three days in all tested animals. Slight, barely perceptible cutaneous reaction was reported 24 hours after application of the test substance in one animal. Scaling was observed in one animal 4 days after application of the test substance. Five days after application of the test substance all animals were free of cutaneous reactions and stainingApplicant's summary and conclusion
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.
