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EC number: 262-104-4 | CAS number: 60207-90-1
- 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:
- 11 Oct 2010 to 18 Oct 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 24 April 2002
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Version / remarks:
- August 1998
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- April 29, 2004
- Qualifier:
- according to guideline
- Guideline:
- other: Commission Regulation (EC) No 440/2008, B.5 (L 142)
- Version / remarks:
- 30 May 2008
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-yl]methyl]-1H-1,2,4-triazole
- EC Number:
- 262-104-4
- EC Name:
- 1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-yl]methyl]-1H-1,2,4-triazole
- Cas Number:
- 60207-90-1
- Molecular formula:
- C15H17Cl2N3O2
- IUPAC Name:
- 1-{[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-yl]methyl}-1H-1,2,4-triazole
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age/weight at dosing: Approximately 13 weeks / 3116-3161 g
- Housing: Individually housed in metal wire rabbit cages
- Acclimatisation period: 12 days
- Diet: Lap gr. diet for rabbit; ad libitum
- Water: Tap water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3°C
- Humidity: 30 - 70%
- Air changes: 15 - 20/hour
- Photoperiod: 12 hours of light/12 hours of dark
IN-LIFE DATES: 11 Oct 2010 to 18 Oct 2010
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: A volume of 0.1 mL - Duration of treatment / exposure:
- Single treatment
- Observation period (in vivo):
- 1, 24, 48, 72 hours and 1 week following treatment
- Number of animals or in vitro replicates:
- 3 animals
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: The eyes of the test animals were not washed out after application of test item.
OBSERVATIONS:
Assessment of ocular damage/irritation was made approximately 1, 24, 48, 72 hours and 1 week following treatment.
Additionally, to assess the presence of corneal damage, fluorescein staining was employed at the following time points after the standard observations have been made:
- At least 24 hours prior to instillation
- At 24 hours post dose
- All subsequent observation times points until Draize scores are zero
The duration of the observation period was sufficient to identify reversibility of changes. Any clinical signs of toxicity or signs of ill-health during the study were recorded.
SCORING SYSTEM:
Assessment of ocular damage/irritation was made approximately according to Draize J H (1977) "Dermal and Eye Toxicity Tests" In: Principles and Procedures for Evaluating the Toxicity of Household Substances, National Academy of Sciences, Washington DC p.48 to 49).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2 and #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2 and #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal: #2 and #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 1 week
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 1 week
- Irritation parameter:
- conjunctivae score
- Remarks:
- (discharge)
- Basis:
- animal: #1, #2 and #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal: #2 and #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 1 week
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Conjunctival redness (score 1), discharge (score 2) and chemosis (score 1) were observed in all animals at the 1 hour observations. Chemosis (score 1) remained in two animals at the 48 hour observation. Conjunctival redness (scores 1/2) persisted in all animals at the 24- and 48- hour observations, and in two animals at the 72 hour observation. One week after treatment no further signs were observed and all local signs had fully reversed in all animals.
Two animals showed a positive fluorescein stain 24 hours after treatment, which was no longer observed at the 48 hour observation. - Other effects:
- - No deaths occurred.
- No systemic signs of toxicity were noted during the study.
- The body weights of the rabbits were considered to be within the normal range of variability.
- Immediately following instillation, slight initial pain (2 on a 0-5 scale) was observed in all animals.
- No abnormal findings were observed in the cornea or iris of any animal at any of the measurement intervals.
Any other information on results incl. tables
Table 1. Eye irritation scores of test item according to the Draize scheme
Rabbit number and sex |
|
|||||||||||||||
Male #1 |
Male #2 |
Male #3 |
||||||||||||||
Time after treatment (h) |
1
|
24
|
48
|
72
|
1 wk |
1
|
24
|
48
|
72
|
1 wk |
1
|
24
|
48
|
72
|
1 wk |
|
CORNEA E = Degree of Opacity F = Area of Cornea involved |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
|
Score (E x F) x 5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
IRIS D |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Score (D x 5) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
CONJUNCTIVAEA=Redness B = Chemosis C =Discharge |
1 1 2 |
2 0 0 |
1 0 0 |
1 0 0 |
0 0 0 |
1 1 2 |
1 1 0 |
1 0 0 |
1 0 0 |
0 0 0 |
1 1 2 |
2 1 0 |
1 0 0 |
0 0 0 |
0 0 0 |
|
Score (A+B+C) x 2 |
8 |
4 |
2 |
2 |
0 |
8 |
4 |
2 |
2 |
0 |
8 |
6 |
2 |
0 |
0 |
|
Total Score |
8 |
4 |
2 |
2 |
0 |
8 |
4 |
2 |
2 |
0 |
8 |
6 |
2 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a primary eye irritation study performend in compliance with GLP and according to OECD 405 guideline the test substance is not an eye irritant.
- Executive summary:
In a primary eye irritation study performed in compliance with GLP and according to OECD 405 guideline, 0.1 mL of the test substance was instilled into the conjunctival sac of the left eye of each of a group of three adult male New Zealand White rabbits. Immediately after instillation of the test material, an assessment of the initial pain reaction was made. Assessment of ocular damage/irritation was made approximately 1, 24, 48, 72 hours and 1 week following treatment, according to a numerical evaluation (Draize JH, 1977). Using the numerical data obtained a modified version of the system described by Kay JH and Calandra JC, 1962 was used to classify the ocular irritancy potential of the test material.
Slight initial pain was observed in all animals. Conjunctival redness, discharge and chemosis were observed in all animals at the 1 hour observations. Chemosis remained in two animals at the 48 hour observation. Conjunctival redness persisted in all animals at the 24- and 48- hour observations, and in two animals at the 72 hour observation. One week after treatment no further signs were observed and all local signs had fully reversed in all animals. Two animals showed a positive fluorescein stain 24 hours after treatment, which was no longer observed at the 48 hour observation. The study was terminated after the 1 week observation. No clinical signs of systemic toxicity were observed in the animals during this study. No intercurrent deaths occurred during this study. The body weights of all rabbits were considered to be within the normal range of variability.
The test substance is not an eye irritant.
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