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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 916-632-3 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1973
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Remarks:
- Test performed before OECD and GLP guidelines. Important aspects (dosing, observation times, grading criteria) comparable with current OECD guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 973
- Report date:
- 1973
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Regulation according to US Federal Hazardous Substance Labeling Act
- Version / remarks:
- 17.09.1964
- GLP compliance:
- no
- Remarks:
- pre-guideline study
Test material
- Reference substance name:
- Disodium 4-amino-3-[[4-[(2-amino-4-hydroxyphenyl)azo]phenyl]azo]-5-hydroxy-6-(phenylazo)naphthalene-2,7-disulphonate
- EC Number:
- 270-629-5
- EC Name:
- Disodium 4-amino-3-[[4-[(2-amino-4-hydroxyphenyl)azo]phenyl]azo]-5-hydroxy-6-(phenylazo)naphthalene-2,7-disulphonate
- Cas Number:
- 68460-07-1
- Molecular formula:
- C28H22N8O8S2.2Na
- IUPAC Name:
- disodium 4-amino-3-({4-[(2-amino-4-hydroxyphenyl)diazenyl]phenyl}diazenyl)-5-hydroxy-6-(phenyldiazenyl)naphthalene-2,7-disulfonate
- Reference substance name:
- Disodium 4-amino-3-[[4-[(2,4-diaminophenyl)azo]phenyl]azo]-5-hydroxy-6-(phenylazo)naphthalene-2,7-disulphonate
- EC Number:
- 272-559-0
- EC Name:
- Disodium 4-amino-3-[[4-[(2,4-diaminophenyl)azo]phenyl]azo]-5-hydroxy-6-(phenylazo)naphthalene-2,7-disulphonate
- Cas Number:
- 68877-33-8
- Molecular formula:
- C28H23N9O7S2.2Na
- IUPAC Name:
- disodium 4-amino-3-({4-[(2,4-diaminophenyl)diazenyl]phenyl}diazenyl)-5-hydroxy-6-(phenyldiazenyl)naphthalene-2,7-disulfonate
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- not specified
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved intact or shaved abraded with a scarifying instrument
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 24 h
- Observation period:
- examinations: 24 and 72 h after application, i.e. 0 and 48 h after the end of treatment/exposure
- Number of animals:
- 3 males and 3 females
- Details on study design:
- 0.5 g of the test substance is spread on a 25 cm2 gauze patch, which is applied on the abraded and intact skin of 6 rabbits, clipped free of hair under occlusive conditions. After 24 hours of exposure, the patches are removed. Reactions are recorded 0 and 48 h after the end of exposure.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- animal: # 1-6 each
- Time point:
- other: mean of 0 and 48 h after the end of exposure
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no signs of irritation (edema) at any time
- Remarks on result:
- other: intact and abraded skin
- Irritation parameter:
- erythema score
- Basis:
- animal: # 1-6 each
- Time point:
- other: mean of 0 and 48 h after the end of exposure
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no signs of irritation (erythema) at any time
- Remarks on result:
- other: intact and abraded skin
- Irritant / corrosive response data:
- No skin reactions were observed in any animal at any time point.
At the first reading after end of exposure discolored skin, caused by the test item, was noted in all animals. This effect was no longer evident at the second reading 48 hours after end of exposure. - Other effects:
- one female animal died (not test material related).
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Regulation (EC) No 1272/2008
- Conclusions:
- According to the classification criteria of Regulation (EC) No 1272/2008 the test material is not irritating to skin under these test conditions.
- Executive summary:
The test material was subject to an acute dermal irritation/corrosion test in 6 rabbits according to the regulation of the US Federal Hazardous Substance Labeling Act. Both intact and scarified skin sites of six rabbits were exposed to 500 mg test substance for 24 h under occlusive conditions and the skin responses were examined 0 and 48 h after the end of exposure. No signs of irritation were observed.
Therefore, the test item has not to be classified for skin irritation according to Regulation (EC) No 1272/2008.
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.
