Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 602-927-1 | CAS number: 123312-89-0
- 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:
- 23 Jul 1991 to 29 Jul 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-4 (Acute Eye Irritation)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Nine instead of 3 rabbits (92/69/EEC B.5.) were used; the eyes of six rabbits remained unwashed for 24 hours, the eyes of the remaining 3 animals were washed 30 seconds after instillation of the test-article
- GLP compliance:
- yes
Test material
- Reference substance name:
- 6-methyl-4-[(E)-[(pyridin-3-yl)methylidene]amino]-2,3,4,5-tetrahydro-1,2,4-triazin-3-one
- EC Number:
- 602-927-1
- Cas Number:
- 123312-89-0
- Molecular formula:
- C10H11N5O
- IUPAC Name:
- 6-methyl-4-[(E)-[(pyridin-3-yl)methylidene]amino]-2,3,4,5-tetrahydro-1,2,4-triazin-3-one
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- Hra:(NZW) SPF
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: adult
- Weight at study initiation: 2116 to 2278 g (for males), 2060 to 2158 (for females in group 1), 2036 to 2238 g (for females in group 2)
- Housing: maintained individually in screen-bottom cages in temperature- and humidity-controlled quarters.
- Diet: a measured amount of High Fiber Rabbit Chow
- Water: ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
Animal husbandry and housing comply with standards outlined in the "Guide for the Care and Use of Laboratory Animals" (NIH publication number No. 86-23, revised 1985). Variations from the prescribed environmental conditions existed and were considered to have had no effect on the study outcome. No contaminants were expected to have been present in the feed or water which would have interfered with or affected the results of the study.
IN-LIFE DATES:
July 25 to July 29, 1991
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.03 g (weight equivalent of 100 μL) placed into the everted lower lid of the right eye.
- Duration of treatment / exposure:
- The eyes of the Group 1 rabbits (6 animals) remained unflushed for 24 hours following instillation of the test material. After 24 hours, the eyes were flushed with lukewarm tap water.
The eyes of the Group 2 rabbits (3 animals) were flushed in the same manner for 1 minute starting 30 seconds after test material instillation. - Observation period (in vivo):
- The treated eyes of both groups were observed for ocular irritation at 1, 24, 48, and 72 hours after treatment. Additional observations were made at 96 hours after treatment for the animals in Group 1.
- Number of animals or in vitro replicates:
- 6 animals (group 1) and 3 animals (group 2)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: lukewarm tap water
- Time after start of exposure: The eyes of the Group 1 rabbits remained unflushed for 24 hours following instillation of the test material. After 24 hours, the eyes were flushed. The eyes of the Group 2 animals were flushed in the same manner for 1 minute starting 30 seconds after test material instillation.
SCORING SYSTEM:
See ‘any other information on materials and methods incl. tables’.
TOOL USED TO ASSESS SCORE: A sodium fluorescein examination was used to aid in revealing possible corneal injury at 72 hours.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 1, 2, 3, 4, 5, 6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal: 1, 2, 3, 4, 5, 6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.22
- Max. score:
- 3
- Reversibility:
- fully reversible within: 96 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 1, 6
- Time point:
- 24/48/72 h
- Score:
- 1.6
- Max. score:
- 3
- Reversibility:
- fully reversible within: 96 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 4
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 96 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 3, 5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 2
- Time point:
- 24/48/72 h
- Score:
- 0.6
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal: 1, 2, 3, 4, 5, 6
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritant / corrosive response data:
- Under both conditions the test material produced iridal involvement (grade 1 injection) limited to 1 hour after instillation observation. Also observed was slight to moderate conjunctival irritation, but no corneal changes. In group 1 the conjunctiva reactions cleared by 96 hours, and in group 2 by 48 hours after instillation. An overview of the data of group 1 can be found in 'any other information on results incl. tables'. Group 2 data is not considered in the final conclusion.
Any other information on results incl. tables
Table 1. Eye irritation scores according to the Draize scheme - unwashed eyes (group 1)
Time |
Cornea opacity |
Iris |
Conjunctiva - redness |
Conjunctiva - chemosis |
||||||||||||||||||||
Rabbit: |
1 |
2 |
3 |
4 |
5 |
6 |
1 |
2 |
3 |
4 |
5 |
6 |
1 |
2 |
3 |
4 |
5 |
6 |
1 |
2 |
3 |
4 |
5 |
6 |
1 hour |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
1 |
1 |
0 |
1 |
2 |
1 |
2 |
2 |
2 |
2 |
1 |
1 |
1 |
1 |
1 |
1 |
24 hours |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
1 |
2 |
2 |
2 |
2 |
1 |
1 |
1 |
1 |
1 |
1 |
48 hours |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
1 |
1 |
1 |
1 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
72 hours |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
96 hours |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
mean scores 24-72h |
0.0 |
0.0 |
1.22 |
0.33 |
||||||||||||||||||||
mean scores 24-72h |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1.6 |
0.6 |
1 |
1.3 |
1 |
1.6 |
0.3 |
0.3 |
0.3 |
0.3 |
0.3 |
0.3 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- This GLP compliant EPA 81-4 study in New-Zealand White rabbits, the averages over 72 hours did not reach irritative thresholds for cornea opacity (score 0), iris (score 0), conjunctivae (score <2) and chemosis (score <2)
- Executive summary:
The primary eye irritation potential of the test substance was evaluated according to US EPA test guideline 81-4 and GLP principles. 0.03 g (100 μL) of test substance was instilled into the eyes of nine New-Zealand White rabbits, six of which received a washout 24 hours after instillation (Group 1) and three of which received a washout 30 seconds after instillation (Group 2). The left eye served as untreated control. In both conditions the test material produced iridal involvement and slight to moderate conjunctival irritation. Under the conditions of the study, no cornea opacity was observed. Slight iris reactions were seen 1 hour after instillation but iris was normal at the 24 hours scoring. Moderate conjunctival redness (score 2) was observed up to 48 hours after instillation but was normal 96 hours post instillation. Moderate conjunctival chemosis (score 1) was observed up to 24 hours after instillation but was normal 48 hours post instillation. Mean scores (24-72 hours) were 1.2 for conjunctival redness (no individual mean ≥ 2) and 0.3 for conjunctival chemosis (no individual mean ≥ 2). The eyes of the Group 1 animals cleared of irritation by 96 hours after instillation. The eyes of the rabbits in Group 2 cleared of irritation by 48 hours after instillation. Based on these results, the substance is considered to be not irritating to the eyes.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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.