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EC number: 941-151-0 | CAS number: 1690331-63-5
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012-11-05
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The reliability is rated 1 because the study followed the standard guideline of reference (OECD 438), which describes a procedure designed to evaluate this endpoint. The results were reviewed for reliability and assessed as valid, and the study was conducted under GLP condition.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU method B.48 (Isolated chicken eye test method for identifying occular corrosives and severe irritants)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- [bis(phenylamino)methylidene]azanium 3-[(1E)-2-[4-(phenylamino)phenyl]diazen-1-yl]benzene-1-sulfonate
- EC Number:
- 941-151-0
- Cas Number:
- 1690331-63-5
- Molecular formula:
- C31H28N6SO3
- IUPAC Name:
- [bis(phenylamino)methylidene]azanium 3-[(1E)-2-[4-(phenylamino)phenyl]diazen-1-yl]benzene-1-sulfonate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material : Sepisol Fast Yellow MG-DPG
- Substance type: Organic salt
- Stability under test conditions: Stable
- Storage condition of test material: room temperature
Constituent 1
Test animals / tissue source
- Species:
- other: eyes from chickens freshly killed
- Details on test animals or tissues and environmental conditions:
- TEST EYES
- Source: Slaughterhouses Etablissement Brun, 33820 Etaulier, France
- Age of the donors animals: approximately 7 weeks old
- Weight of the donors animals: between 1.5 to 2.5 kg
- Transport of eyes: The intact heads were transported from the slaughterhouse at ambient temperature in polystrene boxes humidified with towels moistened with isotonic saline. The eyes are enucleated in the laboratory within less than 1h30 after the the heads are removed
- Time between collection and use of corneas:The corneas were transported to the laboratory straight after removal on animals and used in a maximum delay of 24 hours after reception at the laboratory.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied : 30 mg - Duration of treatment / exposure:
- Treatment of10 secondes
- Observation period (in vivo):
- 4 hours post-treatment
- Number of animals or in vitro replicates:
- 3 chicken eyes for the treatment group
3 chicken eyes for the positive control group
1 chicken eye for the negative control group - Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with 40 mL of physiological saline (4 times for the treatement group and 2 times for the control groups)
- Time after start of exposure: after 10 secondes
SCORING SYSTEM: Determination of ICE classes for 3 endpoints (1- corneal thickness, 2- corneal opacitiy, 3- fluorescein retention) according to a predefine range. Each ICE classes are then combined to generate an Irritancy Classification
TOOL USED TO ASSESS SCORE:
- Corneal thickness : quantitative determination by optical pachymeter on a slit-lamp microscope.
- Corneal opacity: qualitative assessment based on the area of the cornea opacified
- Fluorescein retention : qualitative assessment based on the staining of the cornea
Results and discussion
In vivo
Results
- Irritation parameter:
- other: ICE class
- Basis:
- other: average values of the evaluation of corneal lesions
- Remarks on result:
- other: ICE class II
- Irritant / corrosive response data:
- Maximal mean corneal swelling score: +10% corresponding to the ICE class II
Maximal mean corneal opacity score: 0.2, corresponding to the ICE class I
Mean score of fluorescein retention: 0.8, corresponding to the ICE class II - Other effects:
- no morphological effects were noted, whatever the examination time
Any other information on results incl. tables
Study acceptance criteria:
The concurrent negative and the positive control give an Irritancy Classification that falls within non irritant and severe irritant/corrosive classes, respectively.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The results obtained, under these experimental conditions, enable to conclude that the test item SEPISOL FAST YELLOW MG-DPG must not be classified R41 "Risk of serious damage to eyes", according to the criteria for the classification, packaging and labelling of dangerous substances in compliance with the E.E.C. Directives 67/548, 2001/59 and 99/45. The symbol "Xi" and the danger label "irritant" are not required.
In accordance with the Regulation (EC) No. 1272/2008, the test item must not be classified in category l "irreversible effects on the eye". The signal word "Danger" and hazard statement H318 "Causes serious eye damage" are not required. - Executive summary:
The aim of the study was to evaluate the possible ocular corrosive or severe irritating effects of the test item after administration on enucleated chickeh eyes.
The test item SEPISOL FAST YELLOW MG-DPG was applied, as supplied, at the dose of 30 mg, to 3 enucleated chicken eyes, during l0 seconds. Then the eyes w ere rinsed twice with l0 mL of physiological saline. As there was remaining test item, the eyes w ere rinsed again twice with l0 mL of physiological saline. Test item remained on the cornea of one eye during all the study and on another eye up to the observation time 2 hours.
Three eyes were treated in the same manner (except for a rinse twice with l0 mL of physiological saline) with a positive control and one eye with a negative control. Damages by the test substance were assessed by determination of corneal swelling, opacity, and fluorescein retention at 30, 75, 120, 180 and 240 minutes post-dose.
The experimental protocol was established in accordance with the O.E.C.D. guideline No 438 adopted 07 September 2009 and the test method B.48 - Commission Regulation (EU) No. 11521201 O dated 08 December 201 O (EU Journal L324) - ATP Council regulation No 440/2008 of 30 May 2008 (E. U Journal Ll42).
The ocular reactions observed in eyes treated with the test item were slight to moderate:
- maximal mean score of corneal opacity: 0.2, corresponding to the ICE class I;
- mean score of fluorescein retention: 0.8, corresponding to the ICE class II;
- maximal mean corneal swelling: +l 0%, corresponding to the ICE class II.
The combination of the three endpoints for the positive control, l0% sodium hydroxide, was 3 x IV. Therefore, the positive control is classified as corrosive/severe irritant, as expected.
The combination of the three endpoints for the negative control, physiological saline solution, was 3 x I. Therefore, the negative control is classified as non corrosive/severe irritant, as expected.
The results obtained, under these experimental conditions, enable to conclude that the test item SEPISOL FAST YELLOW MG-DPG must not be classified R41 "Risk of serious damage to eyes", according to the criteria for the classification, packaging and labelling of dangerous substances in compliance with the E.E.C. Directives 67/548, 2001/59 and 99/45. The symbol "Xi" and the danger label "irritant" are not required.
In accordance with the Regulation (EC) No. 1272/2008, the test item must not be classified in category l "irreversible effects on the eye". The signal word "Danger" and hazard statement H318 "Causes serious eye damage" are not required.
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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