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EC number: 231-673-0 | CAS number: 7681-57-4
- 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)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Deviations with no effect on the results: - Purity and stability were not stated. - A slightly modified scoring system was used. The naming of the scale of scoring was different, but otherwise the scoring of chemosis/cornea was from 0-4; conjunctivae redness from 0-3 and iris was from 0-2.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- , see "rational for reliability"
- GLP compliance:
- no
Test material
- Reference substance name:
- Disodium disulphite
- EC Number:
- 231-673-0
- EC Name:
- Disodium disulphite
- Cas Number:
- 7681-57-4
- Molecular formula:
- Na2S2O5
- IUPAC Name:
- disodium disulphite
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): disodium disulphite
-Test substance No.: 84/200
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: GAUKLER; D-6050 OFFENBACH / MAIN, FRG
- Weight at study initiation: Mean weight 2.48 kg (males; one male 2.51 kg and the other male 2.44 kg), 2.40 kg (female)
- Housing: Individually in cages made of stainless steel with wire mesh walk floors; floor area: 40x51 cm; No bedding in the cages; Sawdust in the waste trays
- Diet: Ovator Solikanin 4mm, Muskator-Werke, D-4000 Duesseldorf-1, Germany; about 130 g/animal/day
- Water (e.g. ad libitum): Tap water; about 250 ml/animal/day
- Acclimation period: At least 8 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20 -24 °C
- Relative humidity: 30 - 70%
- Photoperiod (hrs dark / hrs light): 12 / 12
No further information on the test animals was stated.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml bulk volume (ca. 107 mg of the comminuted test substance) to the conjunctival sac of the right eyelid.
No further information on the amount/concentration applied was stated. - Duration of treatment / exposure:
- one application
- Observation period (in vivo):
- 8 days; Readings at 1, 24, 48, 72 hours and on day 8 after application
- Number of animals or in vitro replicates:
- 2 males / 1 female
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
The test substance was not washed out.
SCORING SYSTEM:
SCALE FOR SCORING OCULAR LESIONS:
CHEMOSIS (SW) AND CORNEA (OP)
(OPACITY-DEGREE OF DENSITY) :
0 = NONE
1 = SLIGHT
2 = WELL-DEFINED
3 = SEVERE
4 = VERY SEVERE
CONJUNCTIVAE REDNESS (RED) :
0 = NORMAL
1 = SLIGHT
2 = WELL-DEFINED
3 = SEVERE
IRIS :
0 = NORMAL
1 = CIRCUM-CORNEAL INJECTION
2 = IRITIS
No further information on the study design was stated.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- in 8 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- in 8 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- aniaml #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- in 8 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- in 8 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritant / corrosive response data:
- During the 1-hour reading slight corneal opacity was seen in one animal. Also, at the 1-hour observation well-defined conjunctivae redness and severe chemosis were observed in all animals. At the 1-hour reading detachment of the cornea was seen in one male.
At the 24-hour and 48-hour readings suppuration was seen in all rabbits.
At the 72-hour reading suppuration and contracted pupils were observed in the female and one male.
On day 8 contracted pupils, detachment of the cornea, small retractions in the eyelids and marginal vascularization of the cornea were observed in the female rabbit.
On day 8 detachment of the cornea, small retractions in the eyelids, marginal vascularization of the cornea and pannus were observed in one male rabbit. The other male rabbit was free of ocular effects on day 8.
It was observed that the cornal opacitiy worsened in two animals by day 8. It changed from slight opacity to well-defined opacitiy. Also, it was observed that the well-defined conjunctival redness in two animals, which was seen at the 1, 24, 48, and 72 hours- readdings, was still seen on the last day of observations. The chemosis disappeared in one animal completely by day 8. In the two remaining animals the chemosis became better, but was still seen on day 8.
For the raw data please refer to "Any other information on results incl. tables" below.
Any other information on results incl. tables
Results:
Readings | Animal | Cornea | Iris | Conjunctival | Symptoms | |
Erythema | Chemosis | |||||
1h | 1 | 0 | 0 | 2 | 3 | |
2 | 0 | 0 | 2 | 3 | ||
3 | 1 | 0 | 2 | 3 | DC | |
24 h | 1 | 0 | 0 | 2 | 3 | S |
2 | 0 | 1 | 2 | 2 | S | |
3 | 0 | 0 | 2 | 3 | S | |
48 h | 1 | 1 | 0 | 2 | 2 | S |
2 | 1 | 1 | 2 | 2 | S | |
3 | 1 | 0 | 2 | 2 | S | |
72 h | 1 | 1 | 0 | 2 | 2 | S/PC |
2 | 0 | 0 | 2 | 1 | ||
3 | 1 | 0 | 2 | 2 | S/PC | |
8 d | 1 | 2 | 0 | 2 | 1 | PC/DC/RE/MV |
2 | 0 | 0 | 0 | 0 | ||
3 | 2 | 0 | 2 | 1 | DC/RE/MV/PA | |
mean 24 - 72 h | 1 | 0.7 | 0 | 2 | 2.3 | |
2 | 0.3 | 0.7 | 2 | 1.7 | ||
3 | 0.7 | 0 | 2 | 2.3 | ||
mean | 1 | 0.6 | 0.2 | 2 | 2.1 |
DC - Detachment of the cornea
MV - Marginal vascularization of the cornea
PC - Pupil contracted
PA - Pannus
RE - Small retraction in the eyelid
S - Suppuration
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- According to the EC Regulation No. 1272/2008 and subsequent regulations, the test item is as Category 1 (H319).
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