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EC number: 605-399-0 | CAS number: 165252-70-0
- 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:
- 05/04/1997 - 11/06/1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP, Guideline study: Nine rabbits instead of 3 (92/69/EEC B.5) were used, the eyes of 6 rabbits remaining unwashed (regulatory requirement in US) and the eyes of 3 animals washed 30 seconds after instillation of test article. Clinical signs and body weights (after treatment) not reported.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- (1987)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-4 (Acute Eye Irritation)
- Version / remarks:
- (1982)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF 59 NohSan no. 4200 (1985)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- (RS)-1-methyl-2-nitro-3-(tetrahydro-3-furylmethyl)guanidine
- EC Number:
- 605-399-0
- Cas Number:
- 165252-70-0
- Molecular formula:
- C7H14N4O3
- IUPAC Name:
- (RS)-1-methyl-2-nitro-3-(tetrahydro-3-furylmethyl)guanidine
- Test material form:
- solid: particulate/powder
- Remarks:
- powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: New Zealand White (Hra:(NZW)SPF)
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 14-18 weeks old
- Weight at study initiation: 2334 - 2694 g
- Sex: males and females
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 g - Duration of treatment / exposure:
- - Exposure period: Washed group: 3 rabbits 30-second exposure; Unwashed group: 6 rabbits 96 h
- Post-exposure period: 14-days - Observation period (in vivo):
- - The treated eyes of all animals were examined for ocular irritation reactions 1, 24, 48, 72 and 96 hours and 7 and 14 days after instillation.
- Number of animals or in vitro replicates:
- 9 rabbits, 6 males and 3 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: With water (both eyes of 3 rabbits for 1 minute)
- Time after start of exposure: 30 seconds
SCORING SYSTEM: Irritation reactions were graded and scored according to the Draize technique. Sodium fluorescein examinations were performed to assist the visualisation of possible corneal lesions
- pH: no data
- Statistics: no statistical analyses were employed
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Remarks:
- according to the method of Kay & Calandra
- Basis:
- mean
- Remarks:
- total eye irritation score at each interval for all animals / no. animals in the group
- Time point:
- other: 1 hour
- Score:
- 13
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: unwashed group
- Irritation parameter:
- overall irritation score
- Remarks:
- according to the method of Kay & Calandra (1962)
- Basis:
- mean
- Remarks:
- total eye irritation score at each interval for all animals / no. animals in the group
- Time point:
- other: 24 hours
- Score:
- 14.8
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: unwashed group
- Irritation parameter:
- overall irritation score
- Remarks:
- according to the method of Kay & Calandra (1962)
- Basis:
- mean
- Remarks:
- total eye irritation score at each interval for all animals / no. animals in the group
- Time point:
- other: 48 hours
- Score:
- 6.7
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: unwashed group
- Irritation parameter:
- overall irritation score
- Remarks:
- according to the method of Kay & Calandra (1962)
- Basis:
- mean
- Remarks:
- total eye irritation score at each interval for all animals / no. animals in the group
- Time point:
- other: 72 hours
- Score:
- 3.2
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: unwashed group
- Irritation parameter:
- overall irritation score
- Remarks:
- according to the method of Kay & Calandra (1962)
- Basis:
- mean
- Remarks:
- total eye irritation score at each interval for all animals / no. animals in the group
- Time point:
- other: 96 hours
- Score:
- 1.8
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: unwashed group
- Irritation parameter:
- overall irritation score
- Remarks:
- according to the method of Kay & Calandra (1962)
- Basis:
- mean
- Remarks:
- total eye irritation score at each interval for all animals / no. animals in the group
- Time point:
- other: 7 days
- Score:
- 2.2
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: unwashed group
- Irritation parameter:
- overall irritation score
- Remarks:
- according to the method of Kay & Calandra (1962)
- Basis:
- mean
- Remarks:
- total eye irritation score at each interval for all animals / no. animals in the group
- Time point:
- other: 14 days
- Score:
- 0
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: unwashed group
- Irritation parameter:
- overall irritation score
- Remarks:
- according to the method of Kay & Calandra (1962)
- Basis:
- mean
- Remarks:
- total eye irritation score at each interval for all animals / no. animals in the group
- Time point:
- other: 1 hour
- Score:
- 12
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: washed group
- Irritation parameter:
- overall irritation score
- Remarks:
- according to the method of Kay & Calandra (1962)
- Basis:
- mean
- Remarks:
- total eye irritation score at each interval for all animals / no. animals in the group
- Time point:
- other: 24 hours
- Score:
- 14.7
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: washed group
- Irritation parameter:
- overall irritation score
- Remarks:
- according to the method of Kay & Calandra (1962)
- Basis:
- mean
- Remarks:
- total eye irritation score at each interval for all animals / no. animals in the group
- Time point:
- other: 48 hours
- Score:
- 8.3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: washed group
- Irritation parameter:
- overall irritation score
- Remarks:
- according to the method of Kay & Calandra (1962)
- Basis:
- mean
- Remarks:
- total eye irritation score at each interval for all animals / no. animals in the group
- Time point:
- other: 72 hours
- Score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: washed group
- Irritation parameter:
- overall irritation score
- Remarks:
- according to the method of Kay & Calandra (1962)
- Basis:
- mean
- Remarks:
- total eye irritation score at each interval for all animals / no. animals in the group
- Time point:
- other: 96 hours
- Score:
- 3.3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: washed group
- Irritation parameter:
- overall irritation score
- Remarks:
- according to the method of Kay & Calandra (1962)
- Basis:
- mean
- Remarks:
- total eye irritation score at each interval for all animals / no. animals in the group
- Time point:
- other: 7 days
- Score:
- 1.3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: washed group
- Irritation parameter:
- overall irritation score
- Remarks:
- according to the method of Kay & Calandra (1962)
- Basis:
- mean
- Remarks:
- total eye irritation score at each interval for all animals / no. animals in the group
- Time point:
- other: 14 days
- Score:
- 0
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: washed group
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 1
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 1
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- 1
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 1
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 48 h
- Score:
- 1
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 1
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- > 0 - < 2
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- > 0 - < 2
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- > 0 - < 3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 96 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- > 0 - < 3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 96 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- > 0 - < 3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 96 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- > 0 - < 3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- > 0 - < 3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- > 0 - < 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- > 0 - <= 1
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- > 0 - <= 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 96 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- > 0 - <= 1
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- > 0 - <= 1
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- > 0 - <= 1
- Reversibility:
- fully reversible within: 96 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- > 0 - <= 3
- Reversibility:
- fully reversible within: 14 d
- Irritant / corrosive response data:
- The unwashed eyes of 4 of 6 animals showed slight (grade 1) corneal opacity with epithelial peeling, and iridial irritation in 2 of 6 animals within 24 hours of instillation of dinotefuran (Table 1 and Table 2). The reaction was accompanied by slight to moderate (grade 1 or 2) erythema, chemosis and clear or purulent discharge in all 6 animals. The eyes of 4 of the animals had returned to normal appearance within 96 hours of instillation and the remaining 2 animals had returned to normal 14 days after instillation. A positive reaction occurred in 3 of 3 animals in the washed group and was characterised by slight corneal opacity and slight to moderate erythema, chemosis and discharge. With the exception of one of 3 animals that showed slight erythema and chemosis on day 7, the washed eyes of all animals returned to normal appearance by 96 hours. The appearance of the eyes of the 3rd animal had returned to normal on day 14. The mean irritation scores for all ocular reactions according to Commission Directive 93/21/EEC (Annex VI) were greatest at 24 hours in both the washed and unwashed groups (Table 1). Thereafter, they progressively declined until day 14 at which time all animals in the washed and unwashed eye groups were free of all ocular irritation reactions. None of the individual animal or group mean irritation scores exceeded the EU criteria for classification as “irritating to eyes”.
Any other information on results incl. tables
Table 1: Group mean irritation scores according to Commission Directive 93/21/EEC (Annex VI)
Observation |
Mean irritation scores in the: |
|||||||||
|
Unwashed group at: |
Washed group at: |
||||||||
|
1hr |
24hr |
48hr |
72hr |
96hr |
1hr |
24hr |
48hr |
72hr |
96hr |
Corneal opacity |
0.2 |
0.7 |
0.2 |
0.2 |
0.2 |
0.0 |
1.0 |
0.0 |
0.0 |
0.0 |
Iris lesion |
0.2 |
0.3 |
0.2 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
Erythema |
2.0 |
2.0 |
1.3 |
0.8 |
0.3 |
2.0 |
2.0 |
1.7 |
1.3 |
1.0 |
Edema |
2.0 |
1.5 |
1.2 |
0.3 |
0.2 |
2.3 |
1.7 |
1.3 |
0.7 |
0.7 |
Table 2: Individual irritation scores
Observation |
Time |
Individual scores |
||||||||
|
|
unwashed group |
washed group |
|||||||
|
|
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
Cornea |
1hr |
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
(severity/area) |
24hr |
0 / 0 |
0 / 0 |
1a/ 1 |
1a/ 1 |
1a/ 1 |
1a/ 2 |
1a/ 1 |
1a/ 1 |
1a/ 2 |
(A / B) |
48hr |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
1a/ 1 |
0 / 0 |
0 / 0 |
1a/ 1 |
|
72hr |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
1a/ 1 |
0 / 0 |
0 / 0 |
0 / 0 |
|
96hr |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
|
7days |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
|
14days |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Iris |
1hr |
0 |
0 |
1b |
0 |
0 |
0 |
0 |
0 |
0 |
(C) |
24hr |
0 |
0 |
1b |
0 |
0 |
1b |
0 |
0 |
0 |
|
48hr |
0 |
0 |
0 |
0 |
0 |
1b |
0 |
0 |
0 |
|
72hr |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
96hr |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7days |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
14days |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Redness |
1hr |
2c |
2c |
2c |
2c |
2c |
2c |
2c |
2c |
2c |
(D) |
24hr |
2c |
2c |
2c |
2c |
2c |
2c |
2c |
2c |
2c |
|
48hr |
1 |
1 |
1 |
1 |
2c |
2c |
2 |
1 |
2c |
|
72hr |
0 |
1 |
0 |
1 |
1 |
2 |
1 |
1 |
2c |
|
96hr |
0 |
0 |
0 |
1 |
0 |
1 |
1 |
0 |
2 |
|
7days |
0 |
0 |
0 |
1 |
0 |
2 |
0 |
0 |
1 |
|
14days |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Chemosis |
1hr |
2 |
2 |
2 |
2 |
2 |
2 |
2 |
2 |
3 |
(E) |
24hr |
1 |
2 |
1 |
1 |
1 |
3 |
2 |
1 |
2 |
|
48hr |
1 |
1 |
1 |
1 |
1 |
2 |
1 |
1 |
2 |
|
72hr |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
2 |
|
96hr |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
2 |
|
7days |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
1 |
|
14days |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Discharge |
1hr |
1d |
1d |
2d |
2e |
2e |
2d |
0 |
0 |
1e |
(F) |
24hr |
0 |
1d |
1d |
1d |
1d |
2d |
0 |
0 |
0 |
|
48hr |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
72hr |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
96hr |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7days |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
14days |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
acorneal epithelial peeling;
binjected;
cblanching;
dclear discharge;
epurulent discharge
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Dinotefuran is slightly irritating to the eyes of the rabbit but does not require classification in the EU according to the CLP regulation.
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Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
