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EC number: 228-906-3 | CAS number: 6372-81-2
- 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:
- guideline study
- Remarks:
- According to OECD and GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 84/449/EEC
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Barium bis[2-chloro-5-[(2-hydroxy-1-naphthyl)azo]toluene-4-sulphonate]
- EC Number:
- 225-935-3
- EC Name:
- Barium bis[2-chloro-5-[(2-hydroxy-1-naphthyl)azo]toluene-4-sulphonate]
- Cas Number:
- 5160-02-1
- Molecular formula:
- C17H13ClN2O4S.1/2Ba
- IUPAC Name:
- barium bis{5-chloro-2-[(2-hydroxy-1-naphthyl)diazenyl]-4-methylbenzenesulfonate}
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- - Animal specifics: New Zealand White, conventional breed
- Source: Hoechst AG, breeding colony
- Age at study initiation: 3 to 5 months
- Weight at study initiation: 2.5 kg to 2.8 kg
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls
- Diet (e.g. ad libitum): standard laboratory diet (Altromin 2123) ad libitum, appr. 15 g hay daily
- Water (e.g. ad libitum): deionized chlorinated water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20° ± 3°C (air-condition)
- Humidity (%): 50 ± 20%
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the right untreated eye of each animal served as control respectively
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg - Duration of treatment / exposure:
- One administration 24 hours
- Observation period (in vivo):
- 3 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Application of the substance to the conjunctival sac of the left eye of each animal, the right eyes served as control respectively
REMOVAL OF TEST SUBSTANCE
- Washing: Washing with physiological saline at approx. 37 °C 24 h after administration and at all other designated examination times at which the treated eyes still showed discharge or at which a corneal examination with fluorescein sodium solution (24, 48 and 72 h after administration) took place
- Time after start of exposure: see above
TOOL USED TO ASSESS SCORE: 0.01 % solution of fluorescein sodium, under UV light
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2, #3 each
- Time point:
- other: mean of the 24, 48 and 72 hours reading
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not relevant since on effects occured
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2, #3 each
- Time point:
- other: mean of the 24, 48 and 72 hours reading
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility not relevant since no effects occured
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #2, #3 each
- Time point:
- other: mean of the 24, 48 and 72 hours reading
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: grade 2 (2 anmials) and 1 (1 animal) was observed 1 hour after administration and was fully reversible within 24 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1, #2 each
- Time point:
- other: mean of the 24, 48 and 72 hours reading
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: mean of the 24, 48 and 72 hours reading
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: grade 1 was observed 1 hour after administration and was fully reversible within 24 hours
- Irritant / corrosive response data:
- 1 hour after administration injected vessels up to diffuse crimson red colour and slight swelling of conjunctivae was observed in all animals. All signs of irritation were fully reversible after 48 h.
- Other effects:
- Red staining of eye discharge was observed at 1 hour after application.
Any other information on results incl. tables
Animal | Evaluation interval (after application) | Opacity of cornea | Redness of conjunctiva | Chemosis of conjunctiva | Iris | Red eye discharge | Fluoresceinestaining |
# 1 | 1 hour | 0 | 2 | 2 | 0 | x | |
# 2 | 0 | 2 | 2 | 0 | x | ||
# 3 | 0 | 1 | 1 | 0 | x | ||
# 1 | 24 hours | 0 | 1 | 0 | 0 | 0 | |
# 2 | 0 | 1 | 0 | 0 | 0 | ||
# 3 | 0 | 0 | 0 | 0 | 0 | ||
# 1 | 48 hours | 0 | 0 | 0 | 0 | ||
# 2 | 0 | 0 | 0 | 0 | |||
# 3 | 0 | 0 | 0 | 0 | |||
# 1 | 72 hours | 0 | 0 | 0 | 0 | 0 | |
# 2 | 0 | 0 | 0 | 0 | 0 | ||
# 3 | 0 | 0 | 0 | 0 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In a OECD guideline and GLP compliant primary eye irritation test in rabbits mean scores for cornea, iris and chemosis of conjunctiva were 0 for all animals. Mean scores for redness of conjunctiva were 0.3 for two and 0 for one animal. All signs of irritation were fully reversible after 48 h.
Therefore, the test item has not to be classified according to Regulation (EC) No 1272/2008. - Executive summary:
A study with the test item according to OECD Guideline 405 and EU Method B.5 was performed to investigate the irritation potential to the rabbit eye.
One and 24 hours after treatment the conjunctivae of the animals showed injected blood vessels up to a diffuse crimson red colour. Additionally, a slight swelling and slight from substance coloured eye discharge were observed in the animals one hour after treatment. Mean scores for cornea, iris and chemosis of conjunctiva were 0 for all animals. Mean scores for redness of conjunctiva were 0.3 for two and 0 for one animal. 48 hours after treatment all signs of irritation were reversible.
Therefore, the test item has not to be classified according to Regulation (EC) No 1272/2008.
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