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EC number: 871-500-1 | CAS number: 2268679-24-7
- 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)
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:
- 1-3(Diphenylguanidinium) m-[[p-anilinophenyl]azo]benzenesulfonate
- EC Number:
- 941-151-0
- Molecular formula:
- C31H28N6SO3
- IUPAC Name:
- 1-3(Diphenylguanidinium) m-[[p-anilinophenyl]azo]benzenesulfonate
- Test material form:
- solid: particulate/powder
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 of 10 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 vitro
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- maximal mean score
- Value:
- ca. 0.2
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: ICE class I
- Irritation parameter:
- fluorescein retention score
- Remarks:
- mean score
- Value:
- ca. 0.8
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: ICE class II
- Irritation parameter:
- corneal swelling
- Remarks:
- maximal mean (+ in %)
- Value:
- ca. 10
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: ICE class II
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: no morphological effects were noted, whatever the examination time
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: the combinaison of the 3 endpoints was 3 x class I: classified as non corrosive/severe irritant.
- Acceptance criteria met for positive control: the combinaison of the 3 endpoints was 3 x class IV: classified as corrosive/severe irritant.
- Range of historical values if different from the ones specified in the test guideline:
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Conclusions:
- The results obtained, under these experimental conditions, enable to conclude that the test item must not be classified the test item must not be classified in category l "irreversible effects on the eye", in accordance with the Regulation (EC) No. 1272/2008, 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 was applied, as supplied, at the dose of 30 mg, to 3 enucleated chicken eyes, during 10 seconds. Then the eyes were rinsed twice with 10 mL of physiological saline. As there was remaining test item, the eyes were rinsed again twice with 10 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 10 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. 1152/2010 dated 08 December 2010 (EU Journal L324) - ATP Council regulation No 440/2008 of 30 May 2008 (E. U Journal L142).
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: +10%, corresponding to the ICE class II.
The combination of the three endpoints for the positive control, 10 % 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 must not be classified in category l "irreversible effects on the eye", in accordance with the Regulation (EC) No. 1272/2008.
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