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EC number: 217-588-1 | CAS number: 1897-45-6
- 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:
- 9 Sep 1977 to 16 Oct 1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
- Report date:
- 1977
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- A dose of 0.1 mg of test substance was instilled into one eye of each of three male and three female New Zealand White rabbits. The eyes were examined and scored at 24, 48, and 72 hours, and on days 7 and 14 according to a modified Draize system. A sodium fluorescein dye examination was conducted at 72 hours and on days 7 and 14 in order to detect potential corneal lesions.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Chlorothalonil
- EC Number:
- 217-588-1
- EC Name:
- Chlorothalonil
- Cas Number:
- 1897-45-6
- Molecular formula:
- C8Cl4N2
- IUPAC Name:
- tetrachlorobenzene-1,3-dicarbonitrile
Constituent 1
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: Not reported
- Weight at study initiation: 2002 to 2215 g
- Housing: The rabbits were individually housed in metal metabolism cages in temperature and humidity controlled quarters.
- Diet: Ad libitum
- Water: Ad libitum
IN-LIFE DATES: From: 9 Sep 1977 To: 16 Oct 1977
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 100 mg - Duration of treatment / exposure:
- Single treatment
- Observation period (in vivo):
- 24, 48, and 72 hours, and on days 7 and 14
- Number of animals or in vitro replicates:
- 3 males and 3 females
- Details on study design:
- A dose of 0.1 mg of test substance was instilled into one eye of each of three male and three female New Zealand White rabbits. The left eye served as the untreated control for each rabbit. None of the rabbits received a washout. The eyes were examined and scored at 24, 48, and 72 hours, and on days 7 and 14 according to a modified Draize system. A sodium fluorescein dye examination was conducted at 72 hours and on days 7 and 14 in order to detect potential corneal lesions.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 1, 2, 3, 4, 6
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: Marked chemosis precluded observations for corneal and iridal irritation. Maximum score used due to marked chemosis which precluded a definitive score.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- iris score
- Basis:
- animal: 1, 2, 3, 4, 6
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 14 days (7 days for animal 3 and 4)
- Remarks on result:
- other: Marked chemosis precluded observations for corneal and iridal irritation. Maximum score used due to marked chemosis which precluded a definitive score.
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal: 1, 2, 4
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.8
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal: 5, 6
- Time point:
- 24/48/72 h
- Score:
- 1.5
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: 1, 2, 3, 5, 6
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 3.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritant / corrosive response data:
- The test substance elicited ocular irritation in all six rabbits. Corneal opacities were observed in all eyes at all observation intervals with the exception of five out of six corneas at 24 hours and four out of six corneas at 48 hours which could not be observed due to severe chemosis. Pannus was observed in two out of six eyes at day 7. Vascularization of the corneal surface was noted in five out of six eyes at day 14. Peeling of the corneal epithelium was observed in all rabbits. Dendritic vascularization was noted in two out of six eyes at day 7. The sodium fluorescein dye examination confirmed the occurrence of corneal damage in all rabbits at all observation intervals.
Iritis (iris still reacting to light) was observed in all six eyes. The iris of five eyes at 24 hours, four eyes at 48 hours and one eye at 72 hours could not be observed due to severe chemosis. Iritis was observed in four out of six eyes on day 14.
Conjunctival irritation (redness, chemosis, discharge and blanching) was observed in all rabbits at all observation intervals. Petite conjunctival haemorrhages were observed in all rabbits through day 7 and persisted to day 14 in one rabbit eye.
The maximum mean total Draize score was 99.9 observed at 24 hours. The maximum individual total Draize score was 108.0 observed in three rabbits at 24 hours.
Any other information on results incl. tables
Table 1. results for individual animals
Scores observed after |
24 hours |
48 hours |
72 hours |
7 days |
14 days |
||
Cornea/opacity |
*,2,*,*,*,* |
* ,*, 3,*,*,* |
2,4,2,3,4,3½ |
4,4,4,4,4,4 |
3,4,4,4,4,4 |
||
Iris |
*,0,*,*,*,* |
*,0,1,*,*,* |
2,2,1,*,1,* |
2,2,1,2,1,2 |
0,2,1,2,0,2 |
||
Conjunctiva redness |
2,2,2,2,2,2 |
1½,1½,1,2,2,2 |
2,1,1½,2,2,2 |
1½,1,2,2½,2,2 |
½,1,1,1½,1,1 |
||
Conjunctiva chemosis |
4,4,4,4,4,4 |
4,4,4,4,4,4 |
4,4,4,4,3,4 |
1½,4,1½,4,1½,4 |
1½,2,1½,1½,1½,2 |
||
Conjunctiva discharge |
3,3,3,2,3,2 |
3,2,1½,1,1½,2 |
3,2,2,2,1,2 |
2,2,2,2,1,2 |
0,1,2,1,1,1 |
* Marked chemosis precluded these observations
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- A dose of 0.1 mg test substance produced corneal opacities, pannus, vascularization of the corneal surface, peeling of the corneal epithelium, dendritic vascularization, iritis, conjunctival irritation and petite conjunctival haemorrhages when instilled into the eyes of albino rabbits, Corneal opacity persisted through day 14 in all six rabbits tested.
- Executive summary:
The eye irritation produced by a single application of the test material was assessed in a primary eye irritation study in New Zealand White rabbits (no guideline, GLP). A dose of 0.1 mg of test substance was instilled into one eye of each of three male and three female New Zealand White rabbits. The left eye served as the untreated control for each rabbit. None of the rabbits received a washout. The eyes were examined and scored at 24, 48, and 72 hours, and on days 7 and 14 according to a modified Draize system. A sodium fluorescein dye examination was conducted at 72 hours and on days 7 and 14 in order to detect potential corneal lesions. The test substance elicited ocular irritation in all six rabbits. Corneal opacities were observed in all eyes at all observation intervals with the exception of five out of six corneas at 24 hours and four out of six corneas at 48 hours which could not be observed due to severe chemosis. Pannus was observed in two out of six eyes at day 7. Vascularization of the corneal surface was noted in five out of six eyes at day 14. Peeling of the corneal epithelium was observed in all rabbits. Dendritic vascularization was noted in two out of six eyes at day 7. The sodium fluorescein dye examination confirmed the occurrence of corneal damage in all rabbits at all observation intervals. Iritis (iris still reacting to light) was observed in all six eyes. The iris of five eyes at 24 hours, four eyes at 48 hours and one eye at 72 hours could not be observed due to severe chemosis. Iritis was observed in four out of six eyes on day 14. Conjunctival irritation (redness, chemosis, discharge and blanching) was observed in all rabbits at all observation intervals. Petite conjunctival haemorrhages were observed in all rabbits through day 7 and persisted to day 14 in one rabbit eye.
In conclusion, the test substance produced corneal opacities, pannus, vascularization of the corneal surface, peeling of the corneal epithelium, dendritic vascularization, iritis, conjunctival irritation and petite conjunctival haemorrhages when instilled into the eyes of albino rabbits, Corneal opacity persisted through day 14 in all six rabbits tested.
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