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EC number: 940-267-9 | CAS number: 1185314-63-9
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
not eye irritant for rabbits
not skin irritant for rabbits
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
For skin irritation/corrosion:
Two tests are available on similar substance 1 and 2, both confirming that the substance is not skin irritant.
For eye irritation/corrosion:
Classification for corrosion on the similar EC: 284-407-0 was based on a study on the similar substance 1 presented in the framework of DSD notification of new substances, reporting eye damage not reversible within 28 days (Stahl); few information is available on the study and several attempts to recover the original reports have been made, without success, either by the owner of the notification or the responsible member state (France, presumably).
According to article 3.3.2.6 of CLP Regulation the proposed classification is justified in the following cases:
Case 1)
“These observations include animals with grade 4 cornea lesions and other severe reactions (e.g., destruction of cornea) observed at any time during the test, as well as persistent corneal opacity,discoloration of the cornea by a dye substance, adhesion, pannus, and interference with the function of the iris or other effects that impair sight. In this context, persistent lesions are considered those which are not fully reversible within an observation period of normally 21 days.”
Case 2)
Substances are also classified in Category 1 if, when applied to the eye of an animal, a substance produces:
–at least in one animal effects on thecornea, iris orconjunctiva that are not expected to reverse or have not fully reversed within an observation period of normally 21 days;
and/or
– at least in 2 of 3 tested animals, a positive response of:
– corneal opacity ≥ 3 and/or
– iritis > 1.5
calculated as the mean scores following grading at 24, 48 and 72 hours afterinstallation of the test material.
Case 1) doesn’t apply since the reports cite the following:
Coloration noire de la membrane nictitante réversible à J14 chez 2 animaux et non réversible à 28J chez 1 animal. Cette coloration a empeché l'appreciation de l'erytheme conjonctival jusque J14.
But discoloration is not referred to cornea.
Case 2) applies since the report indicates for conjunctiva score that for all animals the maximum value of redness has been observed at 28 days, while for all the other end points very slight effect has been reported.
Based on the available information the report is missing of many important details, like the identification of the substance and the related impurities and potential additives in case a commercial sample has been tested. No detail comments on controls and animal housing have been reported.
The result is in contradiction with the following complete studies performed on the similar substance 1 and on the other studies on similar substance 2
Study 1: Key study – reliability 2 – Read across study from similar substance 2
J. Zapatero (1997). PRIMARY EYE IRRITATION IN RABBITS TEST SUBSTANCE : CARBON DERMA AF 135. Test Substance: Carbon Derma AF 135. Testing laboratory: CENTRO DE INVESTIGATION Y DESAROLLO APLICADO S. A. L. Report no.: CD-96/5303T-1. Owner company: CLARIANT PRODUCTIONS S. A.
All the effects have been properly assessed and described in detail. No effect has been reported for any end point after 6 days in any animal
Study 2: Supporting study – reliability 2 – Read across study from similar substance 2
BASF AG (1984a). Report on the acute irritation to the eye of the white rabbit based on OECD 405. Testing laboratory: BASF Department of Toxicology. Report no.: 83/259. Owner company: BASF SE. Report date: 1984-03-01 (Original language: German).
The study has been rated Klimish 2 either because it has been performed on the similar substance 2 and it is not a GLP study even if the study is complete and performed according the OECD guideline 405 without deviations.
The substance is well identified and a certificate has been provided for exact composition.
All the effects have been properly assessed and described in detail. No effect has been reported for any end point after 72 hours in any animal.
Study 3: Supporting study – reliability 1 - Read across study from similar substance 1
L. Bisini (2014). ACID BLACK 210 Na, ASSESSMENT OF OCULAR CORROSION/SEVERE IRRITATION, BOVINE CORNEAL OPACITY/PERMEABILITY (BCOP) ASSAY. Testing laboratory: RTC. Report no.: 98470. Owner company: REACH & Colours Kft . (Original language: English).
In order to completely assess the end point the Lead Registrant REACH & Colours Kft performed an in vitro test according to OECD 437, on similar substance 1, which composition has been well defined.
The BCOP test method is recommended as an initial step within a tiered-testing strategy to identify chemicals inducing serious eye damage, i.e. chemicals to be classified as UN GHS Category 1, without further testing. A chemical that is not predicted as causing serious eye damage or as not classified for eye irritation/serious eye damage with the BCOP test method would require additional testing (in vitro and/or in vivo) to establish a definitive classification
According to the updated OECD 437 guideline of 17 September 2012, the IVIS cut-off values for identifying test chemicals as inducing serious eye damage (UN GHS Category 1) and test chemicals not requiring classification for eye irritation or serious eye damage (UN GHS No Category) are given hereafter:
IVIS | UN GHS |
< 3 | No Category |
>3; < 55 | No prediction can be made |
> 55 | Category 1 |
The test resulted in a medium IVIS of 25.3 and alterations of the mean cornea opacity were observed. However, since the test item was coloured, the mean opacity value is affected by the substance remaining on the corneal surfaces. No relevant increases in corneas permeability were recorded after treatment with the test item when compared to those of negative control.
Conclusions
Two Klimish 2 studies (Clariant 1997 and BASF 1984) have been performed on similar substance 2 showing no effect that can trigger to a classification. They are well performed, the substance is well identified and their results are consistent. An in vitro study, according to OECD 437 has been performed on the similar substance 1. The result according to the new update of OECD 437 of the 17 September 2012 cannot lead to a conclusion about the classification, but it can be considered as a weight of evidence, together with the two previous cited study.
Based on read across from similar 1 and 2, Acid Green 68 could be considered as a not-irritating substance.
Read across is discussed more in detail in the Read Across document in section 13.
Justification for classification or non-classification
No classification for skin irritation/corrosion is warranted under Regulation 1272/2008
No classification for eye irritation/corrosion is warranted under Regulation 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.
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