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EC number: 201-579-4 | CAS number: 85-00-7
- 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
- Study period:
- 21 Aug 1996 to 5 Sep 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1987
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 1992
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-4 (Acute Eye Irritation)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Diquat dibromide
- EC Number:
- 201-579-4
- EC Name:
- Diquat dibromide
- Cas Number:
- 85-00-7
- Molecular formula:
- C12H12N2.2Br
- IUPAC Name:
- 1,1'-ethylene 2,2'-bipyridyldiylium dibromide
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- water
- Test material form:
- liquid
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: Young adult
- Weight at study initiation: 3021 - 3077 g
- Housing: Individually in aluminium sheet cage
- Diet: Diet (STANRAB SQC), ad libitum
- Water: Mains water, ad libitum
- Acclimation period: At least 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 ± 2
- Humidity (%): 55 ± 15
- Air changes (per hr): approximately 25 - 30
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From 21 Aug 1996 To: 5Sep 1996
Test system
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- Technical solution
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL - Duration of treatment / exposure:
- Single treatment
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- PREPARATION AND SELECTION OF ANIMALS
The eyes of the animals were examined one day prior to test item administration. Animals with overt signs of ocular injury or irritation which may have interfered with the interpretation of the results were not used in the test.
INSTILLATION
Initially, the test substance (0.1 mL) was instilled into the conjunctival sac of the left eye of one rabbit by gently pulling the lower lid away from the eyeball to form a cup into which the test substance was dropped. The lids were then gently held together for 1 - 2 seconds after which the animal was released. The other eye was untreated (control eye). Immediately after the instillation of the test substance, an assessment of initial pain was made on a 6 point scale.
CAGE SIDE OBERVATIONS
When the eye irritation potential had been fully assessed in the first animal, the test eye of the remaining two animals was assessed. Animals were observed frequently on the day of dosing and daily throughout the remainder of the study.
OCULAR SCORING
The eyes were examined for up to 8 days, to assess the grade of ocular reaction. Irritation was scored by the method of Draize 1959, to assess the grade of ocular reaction approximately one hour and 1, 2 and 3 days after instillation and then at intervals for up to 8 days. In addition, as an aid in the assessment of corneal damage, fluorescein staining was used at all readings from 1 day after instillation. A modified form of the Kay and Calandra (1962) system was used to interpret and classify the numerical scores. This scoring table is derived fom the Draize scoring table, which is included in the "Any other information on materials and methods incl. tables" field. This table will be used to interpret the results from this study.
BODY WEIGHT
The animals were weighed prior to the start of the study.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal: #1, #3
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal: #2
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal: #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritant / corrosive response data:
- Instillation into the eye caused slight initial pain (class 2 on a 0 - 5 scale). No corneal or iridial effects were observed. Conjunctival effects included slight to moderate redness, slight chemosis and slight to moderate discharge. The area around the eye of two of the animals was stained brown or brown/red by the test material. Additional signs of irritation included mucoid and Harderian discharge and erythema and thickening of the eyelids. All effects had completely regressed by day 8.
- Other effects:
- MORTALITY
No deaths occurred.
CLINICAL SIGNS
No systemic signs of toxicity were noted during the study
BODY WEIGHT:
The body weights of the rabbits were considered to be within the normal range of variability.
Any other information on results incl. tables
Table 1: Eye irritation scores of the test substance according to the Draize scheme
Time |
Cornea |
Iris |
Conjunctiva |
||||||||||
|
|
|
|
Redness |
Chemosis |
||||||||
Animal number |
#1 |
#2 |
#3 |
#1 |
#2 |
#3 |
#1 |
#2 |
#3 |
#1 |
#2 |
#3 |
|
after approx. 1 hour |
0 |
0 |
0 |
0 |
0 |
0 |
1 m, st |
1 m |
1 m, st |
1 |
1 |
1 |
|
after 24 hours |
0 |
0 |
0 |
0 |
0 |
0 |
2 m, d, st |
2 e |
2 m, r, st |
1 |
1 |
1 |
|
after 48 hours |
0 |
0 |
0 |
0 |
0 |
0 |
2 m, st |
2 e, d, r |
2 d, r, st, |
1 |
0 |
0 |
|
after 72 hours |
0 |
0 |
0 |
0 |
0 |
0 |
1 st |
1 e, d, r |
1 d, r, st |
0 |
0 |
0 |
|
mean scores 24 - 72h |
0 |
0 |
0 |
0 |
0 |
0 |
1.7 |
1.7 |
1.7 |
0.7 |
0.3 |
0.3 |
|
after 4 days |
0 |
0 |
0 |
0 |
0 |
0 |
1 st |
1 d |
1 d, st |
0 |
0 |
0 |
|
after 7 days |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 st |
0 |
0 |
0 |
|
after 8 days |
- |
0 |
- |
- |
0 |
- |
- |
0 |
- |
- |
0 |
- |
d – Harderian discharge; m – mucoid discharge; st – staining of peri orbital area; e – eyelids thickened; r – erythema of the upper/lower eyelid |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- The test substance is a mild irritant to the rabbit eye.
- Executive summary:
In a primary eye irritation study following OECD TG 405 and in compliance with GLP, 0.1 mL of test substance was instilled into the conjunctival sac of the left eye of each of 3, young adult female, New Zealand White rabbits. Immediately after the instillation of the test substance, an assessment of initial pain was made. The eyes were examined for up to 8 days, to assess the grade of ocular reaction. Irritation was scored by the method of Draize 1959.
Instillation into the eye caused slight initial pain (class 2 on a 0 - 5 scale). No corneal or iridial effects were observed. Conjunctival effects included slight to moderate redness, slight chemosis and slight to moderate discharge. The area around the eye of two of the animals was stained brown or brown/red by the test material. Additional signs of irritation included mucoid and Harderian discharge and erythema and thickening of the eyelids. All effects had completely regressed by day 8.
The test substance is a mild irritant to the rabbit eye.
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