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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 223-460-6 | CAS number: 3905-19-9
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:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- The study was conducted according to the Draize-Test (1959). In contrast to OECD guideline 404 the Draize-test is done under occlusive conditions, exposure time is 24 hrs, substance is applied to intact and abrated skin, and washing of substance after application is omitted.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Draize-Test
- Principles of method if other than guideline:
- The test was conducted according to the patch test technique as described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO).
- GLP compliance:
- no
- Remarks:
- GLP was not mandatory when the study was done
Test material
- Reference substance name:
- N,N'-phenylene-1,4-bis[4-[(2,5-dichlorophenyl)azo]-3-hydroxynaphthalene-2-carboxamide]
- EC Number:
- 223-460-6
- EC Name:
- N,N'-phenylene-1,4-bis[4-[(2,5-dichlorophenyl)azo]-3-hydroxynaphthalene-2-carboxamide]
- Cas Number:
- 3905-19-9
- Molecular formula:
- C40H24Cl4N6O4
- IUPAC Name:
- N,N'-phenylene-1,4-bis[4-[(2,5-dichlorophenyl)azo]-3-hydroxynaphthalene-2-carboxamide]
- Details on test material:
- - Physical state: powder
- Analytical purity: no data
Constituent 1
- Specific details on test material used for the study:
- - Physical state: powder
- Analytical purity: no data
Test animals
- Species:
- rabbit
- Strain:
- other: Russian
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 1.5 - 2.1 kg
- Housing: housing singly in metal cages
- Diet (e.g. ad libitum): Nafag (ad libitum)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18+/- 1
- Humidity (%): 55+/- 5%
- Photoperiod (hrs dark / hrs light): 10/14
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- other: untreated skin from same rabbit was used as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g - Duration of treatment / exposure:
- 24 hrs
- Observation period:
- 7 days
- Number of animals:
- 3 females, 3 males
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap: gauze patch was maintained in place by using an impermeable foil 5 x 5 cm which was fixed by an adhesive tape
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 hrs
SCORING SYSTEM:
- Draize Scoring System
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- all 6 animals were included
- Time point:
- other: 24, 48, 72 hrs
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: no animal had erythema over the complete observation period
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- all 6 animals were included
- Time point:
- other: 24, 48, 72 hrs
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: no animal had edema over the complete observation period
- Irritant / corrosive response data:
- no animal showed signs of irritation
- Other effects:
- Testing was done on intact and scarified skin. Only intact skin was considered for assessment of irritation.
Nevertheless the abraded skin showed no signs of irritation, too.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
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.
