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EC number: 916-604-0 | 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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study performed according to OECD guideline 405 in compliance to GLP.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
- Reference Type:
- other: Published secondary source
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Multi constituent substance
- EC Number:
- 916-604-0
- IUPAC Name:
- Multi constituent substance
- Details on test material:
- Test substance : Basic Brown 17 (COLIPA number B007)
Batch number : NDKS 1944
Methylsulphate anion : 8.2%
Chloride ion : 3.6%
Water : 6.0%
Basic Red 118 : 2.4%
Purity : 96.3% (HPLC)
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 45 mg
- Duration of treatment / exposure:
- Each animal was treated by instillation of the test substance in the conjunctival sac of one eye. The substance remained in permanent contact with the eyes until treatment of the eyes with 2% fluorescein 24 hours after test item instillation.
- Observation period (in vivo):
- All eyes were examined and scored 1, 24, 48, 72 hours and 7 days after instillation of the test substance.
- Number of animals or in vitro replicates:
- Three
- Details on study design:
- Treatment
Each animal was treated by instillation of 45mg (~0.1 mL) of the test substance in the conjunctival sac of the eyes after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of the test substance. The other eye remained untreated and served as the reference control. Immediately after the 24 hour observation, a solution of 2% fluorescein in water (adjusted to pH 7.0) was instilled into both eyes of each animal to quantitatively determine corneal epithelial damage. Any bright green stained area, indicating epithelial damage, was estimated as a percentage of the total corneal area.
Observations
Mortality/viability : Twice daily
Toxicity : At least once daily
Body weight : Day of treatment (prior to instillation) and at termination
Irritation : The eyes of each animal were examined approximately 1, 24, 48 and 72 hours and 7 days after instillation of the test substance. The irritation scores and a description of all other (local) effects were recorded. The irritation was assessed according to the following numerical scoring system. At each observation, the highest scores were recorded.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: mean 24-72 hours
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: mean 24-72 hours
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: mean 24-72 hours
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: mean 24-72 hours
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: mean 24-72 hours
- Score:
- 0.3
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: mean 24-72 hours
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #1
- Time point:
- other: mean 24-72 hours
- Score:
- 1.7
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #2
- Time point:
- other: mean 24-72 hours
- Score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #3
- Time point:
- other: mean 24-72 hours
- Score:
- 1.7
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: mean 24-72 hours
- Score:
- 0.3
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: mean 24-72 hours
- Score:
- 1
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: mean 24-72 hours
- Score:
- 0.3
- Irritant / corrosive response data:
- Instillation of the test item resulted in effects on the iris in two animals and on the conjunctivae in all animals. Iridial irritation grade 1 was observed and had resolved within 24 or 72 hours. The irritation of the conjunctivae consisted of redness, chemosis and discharge and had completely resolved within 7 days in all animals. No corneal opacity was observed. Treatment of the eyes with 2% fluorescein 24 hours after test item instillation revealed no corneal epithelial damage. There was no evidence of ocular corrosion. Remnants of the test substance were present in the eye 1 hour after instillation. Remnants were prsent on the outside of the eyelids 24 and 48 hours after instillation in one animal. Yellow-brown staining of the fur on the head and paws, caused by the test substance, was noted during the observation period. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Any other information on results incl. tables
Individual eye Irritation Scores
Time after Dosing | Cornea Opacity Score | Iris Score | Conjunctivae (Redness) Score | Chemosis Score | Discharge | Comments |
Animal 1 | ||||||
1 hour | 0 | 1 | 2 | 1 | 2 | e, h, b |
24 hours | 0 | 0 | 2 | 1 | 1 | e, c |
48 hours | 0 | 0 | 2 | 0 | 0 | e, c |
72 hours | 0 | 0 | 1 | 0 | 0 | e |
7 days | 0 | 0 | 0 | 0 | 0 | e |
Animal 2 | ||||||
1 hour | 0 | 1 | 2 | 2 | 2 | e, h, b |
24 hours | 0 | 0 | 2 | 2 | 1 | e |
48 hours | 0 | 1 | 2 | 1 | 1 | e |
72 hours | 0 | 0 | 2 | 0 | 0 | e |
7 days | 0 | 0 | 0 | 0 | 0 | e |
Animal 3 | ||||||
1 hour | 0 | 0 | 1 | 2 | 2 | e, h, b |
24 hours | 0 | 0 | 2 | 1 | 2 | e |
48 hours | 0 | 0 | 2 | 0 | 1 | e |
72 hours | 0 | 0 | 1 | 0 | 0 | e |
7 days | 0 | 0 | 0 | 0 | 0 | e |
Comments
b : Remnants of the test substance in the eye
c : Remnants of the test substance on the outside of the eyelids
e : Yellow-brown staining of the head and paws by the test substance
h : No scoring of the lower eyelids was possible because of yellow-brown staining
No ulceration or opacity of cornea observed for all animals at all observation times
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item is not irritating to the rabbit eye.
- Executive summary:
The study was performed according to OECD guideline 405, EU method B.5, US EPA OPPTS 870.2400. Single samples of approximately 45mg of Basic Brown 17 (~0.1 mL) were instilled into one eye of each of three rabbits. Observations were made 1, 24, 48 and 72 hours and 7 days after instillation. Instillation of the test substance resulted in effects on the iris in two animals and on the conjunctivae in all animals. Iridial irritation grade 1 was observed and had resolved within 24 or 72 hours. The irritation of the conjunctivae consisted of redness, chemosis and disharge and had completely resolved within 7 days in all animals. Remnants of the test substance were present in the eye 1 hour after instillation. Remnants were also present on the outside of the eyelids 24 and 48 hours after instillation in one animal. Yellow-brown staining of the fur on the head and paws, caused by the test substance, was noted during the observation period. Based on the results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Council Directive 67/548/EEC) Basic Brown 17 does not have to be classified and has no obligatory labelling requirement for eye irritation.
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