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EC number: 220-168-0 | CAS number: 2650-18-2
- 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:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: well-documented, guideline-conform study report. Dosed amount slightly lower than required by guideline. 0.1 ml of a 38% aqueous solution were applied. This correspons to 38 mg. For the solid with a bulk density of 500 kg/m3, 0.1 ml would have been 50 mg.
- Remarks:
- The study is conducted on a read across test material. The complete read across justification is attached in section 13. The reliability of the original study is 2.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- only observed until day 8, however all findings had resolved.
- GLP compliance:
- no
Test material
- Reference substance name:
- Similar Substance 1
- IUPAC Name:
- Similar Substance 1
Constituent 1
- Specific details on test material used for the study:
- 38% aqueous formulation
(contains 47% water, 7% oxalic acid and other salts)
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- Mean body weights: males 3.0 kg, female 2.91 kg
One animal per cage (type: stainless steel, 40 x 51 cm); animal identification via ear tattoo.
The animals were housed in fully air-conditioned rooms with a room temperature of 20 - 24°C and a relative humidity of 30 - 70%. The day/night rhythm was 12 h light and 12 h dark.
A standardized animal laboratory diet (about 130 g/animal/day) and tap water (about 250 ml/animal/day) were offered.
Acclimatization period: at least 8 days before study start (same housing conditions as during the study).
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of the same animal
- Amount / concentration applied:
- 0.1 ml (corresponds to 38 mg)
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 8 d
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Instillation into the conjunctival sac of the right eye.
Assessment: according to OECD and Draize
Readings: 1 h, 24 h, 48 h, 72 h and 8 day after instillation
Body weight determined on day 0 and day 8
Eyes were examined with fluorescein on day 8.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- other: all three animals
- Time point:
- other: 1h
- Remarks on result:
- not determinable
- Remarks:
- The substance is a blue dye, scoring was not possible.
- Irritation parameter:
- cornea opacity score
- Basis:
- other: all three animals
- Time point:
- 24 h
- Remarks on result:
- not determinable
- Remarks:
- The substance is a blue dye, scoring was not possible.
- Irritation parameter:
- cornea opacity score
- Basis:
- other: all three animals
- Time point:
- other: 48h, 72h, 8 days
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24 h
- Remarks on result:
- not determinable
- Remarks:
- The substance is a blue dye, scoring was not possible.
- Irritation parameter:
- chemosis score
- Basis:
- other: all three animals
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 48 - 72 h
- Score:
- 0.16
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- iris score
- Basis:
- other: all three animals
- Time point:
- other: 1h
- Remarks on result:
- not determinable
- Remarks:
- The substance is a blue dye, scoring was not possible.
- Irritation parameter:
- iris score
- Basis:
- other: all three animals
- Time point:
- 24 h
- Remarks on result:
- not determinable
- Remarks:
- The substance is a blue dye, scoring was not possible.
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 48 h
- Remarks on result:
- not determinable
- Remarks:
- The substance is a blue dye, scoring was not possible.
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 48 h
- Remarks on result:
- not determinable
- Remarks:
- The substance is a blue dye, scoring was not possible.
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- other: all three animals
- Time point:
- other: 72h, 8 days
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritant / corrosive response data:
- Due to transient blue coloring of the eye (for two days in two animals and for one day in one animal), not all values could exactly be determined. The substance is a blue dye.
With the above mentioned restrictions on scoring, no adverse effects were noted on iris and cornea. Swelling of conjunctivae resolved in two animls within 2 days and in one animal within 3 days. Redness of conjunctivae resolved in two animals within 3 days and in one animal within 8 days. - Other effects:
- Body weights remained unchanged during treatment
Animal 1: 2.91 / 2.94 kg (day 0 / day 0)
Animal 2: 3.15 / 3.15 kg (day 0 / day 0)
Animal 3: 2.94 / 2.99 kg (day 0 / day 0)
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- An aqueuous formulation containing 38% of the substance is not irritating to eyes.
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