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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 29 Sep 2010 to 20 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 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- April 24, 2002
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Version / remarks:
- August 1998
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- May 30, 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
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Number of animals per test: 3 (males)
- Age at treatment: ~17 weeks
- Acclimatization: Under laboratory conditions after health examination. Only animals without any visual signs of illness were used for the study.
- Housing: Rabbits were individually housed in AAALC approved metal wire rabbit cages (65x65 cm with height of 45 cm). Cages are of an open wire structure and cages are placed together to allow some social interaction with rabbit(s) in adjoining cages.
- Diet: ad libitum.
- Water: The animals received municipal tap water, as for human consumption, ad libitum, from an automatic system. The drinking water is routinely analysed and is considered not to contain any contaminants that could reasonably be expected to affect the purpose or integrity of the study.
ENVIRONMENTAL CONDITIONS
- Temperature: 17.1-21.4°C
- Relative humidity: 40 -87%
- Ventilation: 15-20 air exchanges/hour.
- Lighting periods: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
IN-LIFE DATES: 29 Sep 2010 to 20 Oct 2010
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g per animal - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 3 weeks
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm back and the flanks of the animal
- Type of wrap if used: Adhesive hypoallergenic plaster; the entire trunk of the animals was wrapped with plastic wrap held in place with an elastic stocking
REMOVAL OF TEST SUBSTANCE
- Washing: The dressing was removed and the skin was flushed with lukewarm tap water to clean the application site
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
- 1, 24, 48, 72 hours, 1, 2 and 3 weeks after the end of exposure.
SCORING SYSTEM:
- Scoring system: The skin reaction was assessed according to the numerical scoring system listed in the Commission Directive 2004/73/EC, April 29, 2004 which was based on the Draize scoring system.
- Method of calculation: The mean score was calculated across 3 scoring times (24, 48 and 72 hours after patch removal) for each animal for erythema/eschar grades and for oedema grades, separately. An animal was positive when the mean score was 2 or greater. The test was positive for irritation when at least 2 animals were positive for the same endpoint (erythema/eschar or oedema).
OBSERVATIONS:
- Viability/mortality, clinical signs and dermal findings were recorded.
- Body weights were recorded at the beginning and at the end of experiment.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #1, #2 and #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 weeks
- Irritation parameter:
- edema score
- Basis:
- animal: #1 and #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 1 week
- Irritation parameter:
- overall irritation score
- Basis:
- animal: #1, #2 and #3
- Time point:
- 24/48/72 h
- Score:
- 1.22
- Max. score:
- 8
- Remarks on result:
- probability of mild irritation
- Irritant / corrosive response data:
- At observations 1 hour after patch removal, very slight oedema (score 1) was observed in 2 animals. Oedema persisted in 1 animal and was observed at the 24- and 48 hour observations. Very slight erythema (score 1) was recorded in all animals from 1 hour after patch removal and at all subsequent observations up to and including the 1 week observations. At the 2 week observations very slight erythema (score 1) was still observed in 2 animals. Dry cracked skin surface was observed in all animals at the 1 week observation and in 1 animal at the 2 week observation.
As signs of irritation were observed after 2 weeks, irreversibility could not be determined and the study was therefore extended by 1 week. All animals fully recovered and showed no local signs at the 3 weeks observation.
Any other information on results incl. tables
Table 1. Skin Irritation Scores - Individual Values
Sex |
Evaluation Interval* |
Erythema |
Oedema |
Cumulative |
|
Score |
Mean |
||||
male |
|
1 |
1 |
2.00 |
|
male |
1 hour |
1 |
0 |
1.00 |
1.67 |
male |
|
1 |
1 |
2.00 |
|
male |
|
1 |
0 |
1.00 |
|
male |
24 hours |
1 |
0 |
1.00 |
1.33 |
male |
|
1 |
1 |
2.00 |
|
male |
|
1 |
0 |
1.00 |
|
male |
48 hours |
1 |
0 |
1.00 |
1.33 |
male |
|
1 |
1 |
2.00 |
|
male |
|
1 |
0 |
1.00 |
|
male |
72 hours |
1 |
0 |
1.00 |
1.00 |
male |
|
1 |
0 |
1.00 |
|
male |
|
1 |
0 |
1.00 |
|
male |
1 week |
1 |
0 |
1.00 |
1.00 |
male |
|
1 |
0 |
1.00 |
|
male |
|
1 |
0 |
1.00 |
|
male |
2 weeks |
1 |
0 |
1.00 |
0.67 |
male |
|
0 |
0 |
0.00 |
|
male |
|
0 |
0 |
0.00 |
|
male |
3 weeks |
0 |
0 |
0.00 |
0.00 |
male |
|
0 |
0 |
0.00 |
|
* Examinations were performed at the specified times after removal of the dressing.
Table 2. Skin Irritaion Scores – Mean Values After 24, 48 and 72 hours
Animal number |
Sex |
Erythema |
N |
Oedema |
N |
Primary Skin Irritaion Index |
1 |
male |
1 |
N |
0 |
3 |
1.22 |
2 |
male |
1 |
N |
0 |
3 |
|
3 |
male |
1 |
N |
0.66 |
3 |
|
Mean score |
1 |
0.22 |
|
N – number of available datapoints
Clinical observations
No clinical signs of systemic toxicity
were observed in the animals during the study.
The body weights of all rabbits were considered to be within the normal
range of variability.
No intercurrent deaths occurred throughout the study.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to the Draize classification criteria the test substance is considered to be a “mild- irritant” to rabbit skin (P.I.I. = 1.22) in the primary skin irritation potential test performed in compliance with GLP and according to the OECD 404 guideline.
- Executive summary:
The primary skin irritation potential of test substance was investigated in compliance with GLP and according to the OECD 404 guideline. The animals were treated by topical semi-occlusive application of 0.5 g to the intact shaved flank of 3 young adult New Zealand White rabbits. The duration of treatment was 4 hours. The scoring of skin reactions was performed 1, 24, 48, 72 hours, 1, 2 and 3 weeks after removal of the dressing. The primary irritation index was calculated by totalling the mean cumulative scores at 24, 48 and 72 hours and then dividing by the number of data points.
The primary irritation index was 1.22. At observations 1 hour after patch removal, very slight oedema (score 1) was observed in 2 animals. Oedema persisted in 1 animal and was observed at the 24- and 48 hour observations. Very slight erythema (score 1) was recorded in all animals from 1 hour after patch removal and at all subsequent observations up to and including the 1 week observations. At the 2 week observations very slight erythema (score 1) was still observed in 2 animals. Dry cracked skin surface was observed in all animals at the 1 week observation and in 1 animal at the 2 week observation. As signs of irritation were observed after 2 weeks, irreversibility could not be determined, and the study was therefore extended by 1 week. All animals fully recovered and showed no local signs at the 3 weeks observation.
The study was terminated after the 3 weeks observation as no signs were observed in the treated animals.
According to the Draize classification criteria the test substance is considered to be a “mild- irritant” to rabbit skin (P.I.I. = 1.22) in the primary skin irritation potential test performed in compliance with GLP and according to the OECD 404 guideline.
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