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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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EC number: 700-174-4 | CAS number: 1029600-34-7
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation, other
- Remarks:
- Unknown - data provided re ECHA's 12-year rule
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- other: All information in this endpoint has been provided by the ECHA using the 12 year rule, this is data is not owned by the registrant . The reliability is estimated to be at level 2 at a minimum.
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- All information in this endpoint has been provided by the ECHA using the 12 year rule, this is data is not owned by the registrant . The reliability is estimated to be at level 2 at a minimum. Therefore the reliability statement below can be used: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of relevant results.
Data source
Reference
- Reference Type:
- other: Data obtained from the ECHA as the data is older than 12 years old
- Title:
- Unnamed
- Year:
- 2 000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of study:
- not specified
Test material
- Reference substance name:
- A mixture of: tert-alkyl(C12-C14)ammonium bis[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphthalenolato(2-)]-chromate(1-); tert-alkyl(C12-C14)ammonium bis[1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphthalenolato(2-)]-chromate(1-); tert-alkyl(C12-C14)ammonium bis[1-[[5-(1,1-dimethylpropyl)-2-hydroxy-3-nitrophenyl]azo]-2-naphthalenolato(2-)]-chromate(1-); tert-alkyl(C12-C14)ammonium [[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphthalenolato(2-)]-[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphthalenolato(2-)]]-chromate(1-); tert-alkyl(C12-C14)ammonium [[1-[[5-(1,1-dimethylpropyl)-2-hydroxy-3-nitrophenyl]azo]-2-naphthalenolato(2-)]-[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphthalenolato(2-)]]-chromate(1-); tert-alkyl(C12-C14)ammonium ((1-(4(or 5)-nitro-2-oxidophenylazo)-2-naphtholato)(1-(3-nitro-2-oxido-5-pentylphenylazo)-2-naphtholato))chromate(1-)
- EC Number:
- 403-720-7
- EC Name:
- A mixture of: tert-alkyl(C12-C14)ammonium bis[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphthalenolato(2-)]-chromate(1-); tert-alkyl(C12-C14)ammonium bis[1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphthalenolato(2-)]-chromate(1-); tert-alkyl(C12-C14)ammonium bis[1-[[5-(1,1-dimethylpropyl)-2-hydroxy-3-nitrophenyl]azo]-2-naphthalenolato(2-)]-chromate(1-); tert-alkyl(C12-C14)ammonium [[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphthalenolato(2-)]-[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphthalenolato(2-)]]-chromate(1-); tert-alkyl(C12-C14)ammonium [[1-[[5-(1,1-dimethylpropyl)-2-hydroxy-3-nitrophenyl]azo]-2-naphthalenolato(2-)]-[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphthalenolato(2-)]]-chromate(1-); tert-alkyl(C12-C14)ammonium ((1-(4(or 5)-nitro-2-oxidophenylazo)-2-naphtholato)(1-(3-nitro-2-oxido-5-pentylphenylazo)-2-naphtholato))chromate(1-)
- IUPAC Name:
- 403-720-7
- Reference substance name:
- Orasol Black RLI
- IUPAC Name:
- Orasol Black RLI
- Details on test material:
- We do not have any details on the test material as the data was obtained from the ECHA using the 12 year rule. However below are a list of reasons why read across is suitable.
Due to the following reasons we wish to read across to the substance containing EC number 403-720-7:
The test substance and analogue substance (403-720-7) have very similar structural properties, the only difference between the two substances are that the counter cations are different. Valifast black contains a mixture of both ammonium and sodium cations whereas the analogue material (403-720-7) contains only tert C12-C14. alkylammonium ions. The ammonium and sodium ions present in Valifast black are unlikely to be toxic and their contribution to the toxicity of Valifast black is trivial. The anion components are the same for both substances and these appear to be key for the toxicity of the substance.
The relative density and the water solubility of the two substances are very similar as shown in the read across proposal (please find the read across proposal attached in section 13).
The analogue material EC 403-720-7 is not expected to accumulate in the environment. Due to the slightly higher log Pow (4.94 - 4.97) for the test material (Valifast Black 3810) the test substance has the potential to accumulate into the environment. As the test substance has a higher potential to acumulate into the environment, read across is still appropriate.
Neither the test material or the analogue material are classified with regards to the acute oral toxicity study. However both substances did provide a positive response both with and without metabolic activation in the Ames study.
It is our understanding that the ready biodegaradtion study is a key property of the substance and that the use of read across is not normally permitted. However in this case the analogue material (EC number 403-720-7) is not readily biodegaradable therefore we will be using a worst case result. Using read across will not cause any effect towards the classification or the labelling of Valifast black as the substance is not readily biodegaradble.
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- other: no data
- Strain:
- not specified
- Sex:
- not specified
Results and discussion
In vivo (non-LLNA)
Results
- Key result
- Reading:
- other: No information - data provided re ECHA's 12-year rule
- Clinical observations:
- No information - data provided re ECHA's 12-year rule
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
The analogue substance (EC# 403 -720 -7) is not classified as a skin irritant according to Directive 67/548/EEC.
Applicant's summary and conclusion
- Interpretation of results:
- no data
- Remarks:
- Migrated information
- Conclusions:
- The analogue substance (EC# 403 -720 -7) is not classified as a skin irritant according to Directive 67/548/EEC.
- Executive summary:
The analogue substance (EC# 403 -720 -7) is not classified as a skin sensitiser according to Directive 67/548/EEC.
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.
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