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Diss Factsheets
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EC number: 947-131-8 | CAS number: -
- 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 vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: "Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965
- GLP compliance:
- no
Test material
- Reference substance name:
- Acid Brown 238
- IUPAC Name:
- Acid Brown 238
- Test material form:
- solid: particulate/powder
- Details on test material:
- The substance was suspended in tap water before the administration.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
Strain: Porton
Age at study initiation: 9-13 weeks
Weight at study initiation: 2.36 Kgs. (males) and 2.55 Kgs (female)
Housing: maintained under a semi-barrier system. Caged singly in an experimental room
Diet: bred on the premises and maintained under a semi-barrier system. Commercial irradiated diet (Styles-Oxoid) was fed ad lib
Water: ad libitum, Sterile filtered
Acclimation period: acclimatized in the test area for one week prior to the start of the trial
ENVIRONMENTAL CONDITIONS
Temperature: 20 °C +/- 1°C
Humidity: 50-70 %
Photoperiod (hrs dark / hrs light): from 08.00 - 18.00 hours artificial light
Test system
- Vehicle:
- water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- The rabbits were examined 1, 24, 48 and 72 hours after application of the test compound and for any further period that was considered necessary.
- Observation period (in vivo):
- The eyes of the experimental animals were examined and found normal prior to the test.
14 days - Number of animals or in vitro replicates:
- 6 rabbits (3 male, 3 female)
- Details on study design:
- The test compound were instilled into the conjunctival sac of the left eye. The eyelids were then held closed for 1 second. After 30 seconds the compound was, as far as possible, flushed out of the eyes- of three of the rabbits with warm water for 1 minute.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal:
- Remarks:
- all of six animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal: all of the six animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: six animals/6
- Time point:
- 24 h
- Score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: one animal/6
- Time point:
- 48 h
- Score:
- 0.17
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: all otf the six animals
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal: two anilmals/6
- Time point:
- 24 h
- Score:
- 0.83
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: one animals/6
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal: six animals
- Time point:
- 72 h
- Score:
- 0
- Irritant / corrosive response data:
- A very slight to mild conjunctival reaction was seen in all treated eyes one hour after application of the compound. These reactions subsided slowly over the subsequent days until all had returned to normal by 48 hours (1/3 washed eyes), 6 days (2/3 washed eyes), 10 days (2/3 unwashed eyes) and 14 days (l/3 unwashed eyes). Staining of the conjunctivae by the compound was seen in all three unwashed eyes for up to 72 hours. Transient damage to the surface epithelium of the cornea was seen at one hour only in one rabbit (No.12).
Applicant's summary and conclusion
- Interpretation of results:
- other: minimal eye irritant
- Remarks:
- Criteria: Drugs and Cosmetics" page 51, published by the Association of Food and Drug Officials of the U.S.A.
- Conclusions:
- minimal eye irritant in the albino rabbit
- Executive summary:
The test was carried out according to the method given in the "Hazardous Substances Regulations" under the U.S. Federal Hazardous
Substances Labelling Act Sect. 191.11 (February 1965).
In to the left eye of six rabbits (3 male, 3 female) 100 g of the test compound was instilled into the conjunctival sac. The eyelids were then held closed for 1 second. After 30 seconds the compound was, as far as possible, flushed out of the eyes of three of the rabbits with warm water for 1 minute.
Observation was done at 24 and 72 hours and 14 days.
A very slight to mild conjunctival reaction was seen in all treated eyes one hour after application of the compound. These reactions subsided slowly over the subsequent days until all had returned to normal by 48 hours (1/3 washed eyes), 6 days (2/3 washed eyes), 10 days (2/3 unwashed eyes) and 14 days (1/3 unwashed eyes). Staining of the conjunctivae by the compound was seen in all three unwashed eyes for up to 72 hours. Transient damage to the surface epithelium of the cornea was seen at one hour only in one rabbit (No.12).
The substance is considere minimal eye irritant in the albino rabbit.
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