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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
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- short-term repeated dose toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 410 (Repeated Dose Dermal Toxicity: 21/28-Day Study)
- Version / remarks:
- 1981
- GLP compliance:
- yes
- Limit test:
- no
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:
- rat
- Strain:
- other: Hanlbm:WIST (SPF)
- Sex:
- male/female
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 1% carboxymethylcellulose and 0.1% aqueous Tween80
- Duration of treatment / exposure:
- 6 hours
- Frequency of treatment:
- 4 weeks on an at least a 5 day/week basis
Doses / concentrationsopen allclose all
- Dose / conc.:
- 10 mg/kg bw/day
- Dose / conc.:
- 100 mg/kg bw/day
- Dose / conc.:
- 1 000 mg/kg bw/day
- Control animals:
- yes, concurrent vehicle
Results and discussion
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 100 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- organ weights and organ / body weight ratios
- Dose descriptor:
- NOAEL
- Effect level:
- 100 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- clinical biochemistry
- dermal irritation
- organ weights and organ / body weight ratios
Target system / organ toxicity
- Critical effects observed:
- no
Any other information on results incl. tables
There were no
mortalities and no clinical signs or signs of local irritation. There
were no treatmentrelated effects on body weight development, food
consumption, food utilisation, ophthalmoscopy or haematological
parameters.
Slightly higher values for protein and globulin with an associated
decrease in the albumin to globulin ratio were recorded for females at
1000 mg/kg bw/day. In addition, females at 1000 mg/kg bw/day had an
increased cholesterol level and females at 100 and 1000 mg/kg bw/day had
lower values for chloride.
In the absence of a dose-response relationship, significantly lower
glucose value in females at 100 mg/kg bw/day and significantly higher
globulin value in females at 10 mg/kg bw/day were considered not
relevant.
The blood chemistry profile of treated males was not affected. In the
absence of a dose-response relationship, significantly lower
triglyceride concentration in males at 10 mg/kg bw/day were considered
not relevant. Significantly higher mean values for sodium in males at
100 and 1000 mg/kg bw/day dose levels were not considered to be
treatment-related as the magnitude of the difference from controls was
too small to be toxicologically relevant.
Table 1.
Differences in clinical chemistry parameters in treated females (mean
values) compared to control animals
Parameter |
Unit |
Control |
10 mg/kg |
100 mg/kg |
1000 mg/kg |
Glucose |
mmol/L |
6.689 |
5.890 |
5.272** |
5.779 |
Protein |
g/L |
62.680 |
64.969 |
64.869 |
66.205** |
Albumin (A) |
g/L |
33.502 |
34.467 |
34.770 |
34.620 |
Globulin (G) |
g/L |
29.179 |
30.502* |
30.099 |
31.585** |
A/G |
1.151 |
1.133 |
1.156 |
1.099 S.D. 0.058 |
|
Cholesterol |
mmol/L |
1.258 |
1.300 |
1.321 |
1.618* |
Cl- |
mmol/L |
100.98 |
100.01 |
98.97* |
98.64* |
* = p < 0.05
** = p < 0.01
Table 2. Differences in clinical chemistry parameters in treated males (mean values) compared to control animals
Parameter |
Unit |
Control |
10 mg/kg |
100 mg/kg |
1000 mg/kg |
Triglycerides |
mmol/L |
0.540 |
0.351* |
0.501 |
0.758 |
Na+ |
mmol/L |
144.01 |
145.20 |
145.69* |
145.73* |
* = p < 0.05
The mean absolute/relative liver weights were increased in 1000 mg/kg
bw/day males (+19%/+15%)
and females (+14%/+10%).
Table 3.
Mean liver weights in males and females
Sex |
Weight |
Control |
10 mg/kg |
100 mg/kg |
1000 mg/kg |
Male |
Liver g |
12.60 |
12.83 |
13.24 |
14.98** |
Liver |
43.8 |
45.1 |
46.6 |
50.4** S.D. 3.0 |
|
Female |
Liver g |
9.2178 |
9.3556 |
9.4583 |
10.51 |
Liver |
45.5 |
44.3 |
45.2 |
49.8* S.D. 3.8 |
There were no
treatment-related macroscopic changes. There was an increased incidence
of minimal acanthosis at the application site of skin of females at 1000
mg/kg bw/day. Minimal hyperkeratosis was increased in treated males but
without a clear dose relationship.
Table 4. Findings at application site
Finding/Sex |
Grade |
Control |
10 mg/kg |
100 mg/kg |
1000 mg/kg |
Acanthosis/Male |
1 |
8 |
7 |
9 |
8 |
2 |
1 |
0 |
0 |
2 | |
Total |
9 |
7 |
9 |
10 | |
Acanthosis/Female |
1 |
1 |
3 |
0 |
8 |
2 |
0 |
0 |
0 |
0 | |
Total |
1 |
3 |
0 |
8 | |
Hyperkeratosis/Male |
1 |
1 |
4 |
8 |
6 |
Total |
1 |
7 |
8 |
6 | |
Hyperkeratosis/Female |
1 |
2 |
0 |
1 |
1 |
Total |
2 |
0 |
1 |
1 |
Applicant's summary and conclusion
- Conclusions:
- Based on the increased liver weights in males and females and concomitant differences in clinical chemistry parameters at 1000 mg/kg bw/day in females and acanthosis at the application site of skin of females at 1000 mg/kg bw/day, the NOAEL in this 28-day dermal rat study was 100 mg/kg bw/day.
- Executive summary:
This study in rats was conducted to determine the dermal toxicity of the test item when applied under occlusive dressing to the clipped area of skin on the back of rats for a period of 4 weeks on an at least 5 day/week basis. No application was performed on weekend days during treatment weeks 1, 2, and 3, but was done on the weekend days of treatment week 4. The exposure period was 6 hours per day. The test item, suspended in vehicle, was administered at the selected dose levels to a total of 80 rats, 10 males and 10 females per dose group. The applied quantities of test item were adjusted daily to individual animal body weights. Control animals (group 1) were treated with the vehicle only. Clinical signs, body weight, food consumption, and mortality were monitored throughout the study for all animals. In addition, detailed clinical observations were performed weekly. Hematological and blood chemistry analyses were performed at treatment end. At sacrifice, animals were examined macroscopically, and organ weights were recorded. Organs and tissues were collected and prepared for histopathological evaluation. Organs and tissues were examined microscopically. The test item was distributed homogeneously in the vehicle and was proven to be stable at the targeted concentrations.
There were no mortalities and no clinical signs or signs of local irritation. There were no treatmentrelated effects on body weight development, food consumption, food utilisation, ophthalmoscopy or haematological parameters. Slightly higher values for protein and globulin with an associated decrease in the albumin to globulin ratio were recorded for females at 1000 mg/kg bw/day. In addition, females at 1000 mg/kg bw/day had an increased cholesterol level and females at 100 and 1000 mg/kg bw/day had lower values for chloride. In the absence of a dose-response relationship, significantly lower glucose value in females at 100 mg/kg bw/day and significantly higher globulin value in females at 10 mg/kg bw/day were considered not relevant. The blood chemistry profile of treated males was not affected. In the absence of a dose-response relationship, significantly lower triglyceride concentration in males at 10 mg/kg bw/day were considered not relevant. Significantly higher mean values for sodium in males at 100 and 1000 mg/kg bw/day dose levels were not considered to be treatment-related as the magnitude of the difference from controls was too small to be toxicologically relevant. The mean absolute/relative liver weights were increased in 1000 mg/kg bw/day males (+19%/+15%) and females (+14%/+10%). There were no treatment-related macroscopic changes. There was an increased incidence of minimal acanthosis at the application site of skin of females at 1000 mg/kg bw/day. Minimal hyperkeratosis was increased in treated males but without a clear dose relationship.
Based on the increased liver weights in males and females and concomitant differences in clinical chemistry parameters at 1000 mg/kg bw/day in females and acanthosis at the application site of skin of females at 1000 mg/kg bw/day, the NOAEL in this 28-day dermal rat study was 100 mg/kg bw/day.
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