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: 270-877-4 | CAS number: 68479-98-1
Toxicological information
Skin irritation / corrosion
Currently viewing:
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Experimental work performed during April and May 1983
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study was performed according to OECD Test Guideline 404 Acute Dermal Irritation/Corrosion and in compliance with Good Laboratory Practice standards.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Diethylmethylbenzenediamine
- EC Number:
- 270-877-4
- EC Name:
- Diethylmethylbenzenediamine
- Cas Number:
- 68479-98-1
- Molecular formula:
- C11H18N2
- IUPAC Name:
- diethylmethylbenzenediamine
- Details on test material:
- - Name of test material (as cited in study report): P5183
- Physical state: Brown viscous fluid
- Composition of test material, percentage of components:
76.4% 3,5-diethyl-2,4-diaminotoluol
21.0% 3,5-diethyl-2,6-diaminotoluol
- Analytical purity: 97.4%
- Impurities (identity and concentrations):
0.6% ?-ethyl-2,?-diaminotoluol
0.8% ?-ethyl-2,?-diaminotoluol
traces 2,6-diethylaniline
0.2% forward unknown
0.9% trailing unknown
0.165 wt% tar
0.009% water content
- Storage condition of test material: Room temperature in the dark
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Bantin and Kingman Ltd., The Field Station, Grimston, Aldborough, Hull, HU11, 4QE
- Weight at study initiation: 2.98 to 3.46 kg
- Housing: individually, grid floor cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 3 days
ENVIRONMENTAL CONDITIONS
- Temperature: 17 to 20°C
- Humidity: 47 to 65%
- Photoperiod (hrs dark / hrs light): 10 hrs dark/ 14 hrs light
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Untreated areas of skin served as a control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: test material applied to an area of skin approximately 6 cm^2, volume not stated
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- The test material was administered once only for a contact period of 4 hours.
- Observation period:
- One hour after removal of the wrappings, the skin reactions were scored. The evaluation was repeated 24, 48 and 72 hours after removal of the patches.
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm^2
- Type of wrap if used: occlusive
REMOVAL OF TEST SUBSTANCE
- Washing: The test material was removed by skin wipe with a disposable paper towel moistened with water.
- Time after start of exposure: 4 hours
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 (beet redness) to slight eschar formation (injuries in depth)
Oedema formation
0 = no oedema
1 = very slight oedema (barely perceptible)
2 = slight oedema (edges of area well-defined by definite raising)
3 = moderate oedema (raised approximately 1 mm)
4 = severe oedema (raised more than 1 mm and extending beyond the area of exposure)
All other reactions were recorded.
* Draize, J.H. (1959) Association of the Food and Drug Officials in the U.S., Austin, Texas, "The appraisal of the safety of chemicals in foods, drugs and cosmetics".
EVALUATION OF DATA
The sum of the 24 and 72 hour values for erythema and oedema (12 scores) was divided by 6 to give the primary irritation index of the test material. The test material was classified according to the following scheme:
Primary irritation index / Classification of irritancy
0 / non-irritant
>0 - 2 / slight
>2 - 5 / moderate
>5 / severe
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- animal #1
- Time point:
- other: 72 hours
- Score:
- ca. 0
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- animal #2
- Time point:
- other: 72 hours
- Score:
- ca. 0
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- animal #3
- Time point:
- other: 72 hours
- Score:
- ca. 0
- Irritant / corrosive response data:
- No positive observations of erythema or oedema were noted in any animal during the 72 hour observation period.
Applicant's summary and conclusion
- Conclusions:
- The test material was not irritating to rabbit skin and was not corrosive.
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.
