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EC number: 619-020-1 | CAS number: 94361-06-5
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26 Jul 2005 to 31 Aug 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Version / remarks:
- 2003
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF 59 NohSan No. 4200, January 28
- Version / remarks:
- 1985
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Currently no LLNA study is available for assessment. The Buehler test has been carried out as an animal test to predict human sensitization for over a decade and is recommended by international test guidelines such as OECD.
Test material
- Reference substance name:
- 2-(4-chloro-phenyl)-3-cyclopropyl-1-[1,2,4]triazol-1-yl-butan-2-ol
- Cas Number:
- 94361-06-5
- Molecular formula:
- C15H18ClN3O
- IUPAC Name:
- 2-(4-chloro-phenyl)-3-cyclopropyl-1-[1,2,4]triazol-1-yl-butan-2-ol
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Remarks:
- Albino
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Females nulliparous and non-pregnant: Yes
- Age at study initiation: Young adult
- Weight at study initiation: 298-460 g at experimental start
- Housing: The animals were group housed in suspended stainless steel caging with mesh floors or plastic perforated bottom caging which conform to the size recommendations in the most recent Guide for the Care and Use of Laboratory Animals DHEW (NIH). Litter paper was placed beneath the cage and was changed at least three times per week.
- Water: ad libitum
- Acclimation period: 10 or 22 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22
- Photoperiod (hrs dark / hrs light): 12/12
- IN-LIFE DATES: 26 Jul 2005 to 31 Aug 2005
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- CMC (carboxymethyl cellulose)
- Concentration / amount:
- 75% w/w mixture of the test substance in a 1% w/w solution of CMC in distilled water
- Day(s)/duration:
- Day 0, 7, and 14: Occlusive dressing for 6 hours
Challengeopen allclose all
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- CMC (carboxymethyl cellulose)
- Concentration / amount:
- 75% w/w mixture of the test substance in a 1% w/w solution of CMC in distilled water) in test animals
- Day(s)/duration:
- Day 27: Evaluation for a sensitization response after 24 and 48 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- CMC (carboxymethyl cellulose)
- Concentration / amount:
- 75% w/w mixture of the test substance in a 1% w/w solution of CMC in distilled water in naive control animals
- Day(s)/duration:
- Day 27: Evaluation for a sentization response after 24 and 48 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Preliminary Irritation Group: 4
Test Group: 20
Naive Control Group: 10 - Details on study design:
- RANGE FINDING TESTS:
MAIN STUDY
A. INDUCTION EXPOSURE
- Exposure period: 6 hours
- Test groups: 75% w/w mixture of the test substance in a 1% w/w solution of CMC in distilled water
- Control group: Untreated
- Site: The left side of each test animal using an occlusive 25 mm Hill Top Chamber
- Frequency of applications: Once each week for three weeks
- Concentrations: Four-tenths of a gram of a 75% w/w mixture of the test substance in a 1% w/w solution of CMC in distilled water
B. CHALLENGE EXPOSURE
- Test groups: Test Animals (75% w/w mixture of the test substance in a 1% w/w solution of CMC in distilled water
- Control group: Naive Control Animals (75% w/w mixture of the test substance in a 1% w/w solution of CMC in distilled water
- Site: On the right side of each test animal
- Concentrations: Four-tenths of a gram of a 75% w/w mixture of the test substance in a 1% w/w solution of CMC in distilled water
- Evaluation (hr after challenge): 24 and 48 hours
OTHER:
Body weight: Individual body weights of the animals were recorded prior to the initial induction and again the day after the challenge application. - Challenge controls:
- Not performed
- Positive control substance(s):
- yes
- Remarks:
- alpha-Hexylcinnamaldehyde
Results and discussion
- Positive control results:
- The positive response observed in the historical positive control validation study with alpha-Hexylcinnamaldehyde (HCA) validates the test system used in this study
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 75% w/w mixture of the test substance in a 1% w/w solution of CMC in distilled water
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Clinical observations:
- Very faint erythema
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Irritation cleared from all affected sites by 48 hours.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 75% w/w mixture of the test substance in a 1% w/w solution of CMC in distilled water
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Clinical observations:
- Very faint erythema
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Naive Control Animals. Irritation cleared from all affected sites by 48 hours.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 75% w/w mixture of HCA in mineral oil
- No. with + reactions:
- 4
- Total no. in group:
- 9
- Clinical observations:
- Faint to very faint erythema
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- persisting at 48h
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 75% w/w mixture of HCA in mineral oil
- No. with + reactions:
- 3
- Total no. in group:
- 5
- Clinical observations:
- Very faint erythema
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Historical Naive Control Animals. Irritation persisted at one of these sites through 48 hours
Any other information on results incl. tables
Table 1. Body weights (test substance)
Animal No. |
Sex |
Initial (g) |
Day after Challenge (g) |
26864 |
M |
437 |
558 |
26865 |
M |
416 |
502 |
26866 |
M |
421 |
642 |
26867 |
M |
392 |
605 |
26868 |
M |
413 |
680 |
26869 |
M |
426 |
633 |
26870 |
M |
460 |
643 |
26871 |
M |
412 |
647 |
26872 |
M |
396 |
546 |
26873 |
M |
374 |
533 |
26874 |
M |
427 |
613 |
26875 |
M |
416 |
558 |
26876 |
M |
410 |
588 |
26877 |
M |
439 |
606 |
26878 |
M |
378 |
544 |
26879 |
M |
391 |
596 |
26880 |
M |
361 |
597 |
26881 |
M |
360 |
573 |
26882 |
M |
364 |
498 |
26883 |
M |
353 |
496 |
Table 2. Body weights (naive group)
Animal No. |
Sex |
Initial (g) |
Day after Challenge (g) |
26884 |
M |
386 |
559 |
26885 |
M |
369 |
590 |
26886 |
M |
394 |
512 |
26887 |
M |
387 |
557 |
26888 |
M |
362 |
533 |
26889 |
M |
391 |
604 |
26890 |
M |
333 |
565 |
26891 |
M |
298 |
467 |
26892 |
M |
416 |
649 |
26893 |
M |
394 |
620 |
Table 3. Induction phase skin reactions scores (test substance)
Induction Number |
1 |
2 |
3 |
|||
Concentration1 |
75% |
75% |
75% |
|||
Amount Applied(g) |
0.4 |
0.4 |
0.4 |
|||
Hours2 |
24 |
48 |
24 |
48 |
24 |
48 |
Animal No. |
|
|||||
26864 |
0.5 |
0 |
0 |
0 |
0.5 |
0 |
26865 |
0 |
0 |
0.5 |
0 |
0 |
0 |
26866 |
0.5 |
0 |
0 |
0 |
0 |
0 |
26867 |
0 |
0 |
0 |
0 |
0 |
0 |
26868 |
0.5 |
0 |
0.5 |
0 |
0.5 |
0 |
26869 |
0 |
0 |
0 |
0 |
0 |
0 |
26870 |
0 |
0 |
0 |
0 |
0 |
0 |
26871 |
0 |
0 |
0.5 |
0 |
0 |
0 |
26872 |
0 |
0 |
0 |
0 |
0.5 |
0 |
26873 |
0 |
0 |
0.5 |
0 |
0 |
0 |
26874 |
0 |
0 |
0.5 |
0 |
0 |
0 |
26875 |
0 |
0 |
0 |
0 |
0 |
0 |
26876 |
0 |
0 |
0 |
0 |
0 |
0 |
26877 |
0 |
0 |
0 |
0 |
0 |
0 |
26878 |
0.5 |
0 |
0 |
0 |
0 |
0 |
26879 |
0.5 |
0 |
0 |
0 |
0 |
0 |
26880 |
0 |
0 |
0.5 |
0 |
0 |
0 |
26881 |
0.5 |
0 |
0 |
0 |
0.5 |
0 |
26882 |
0 |
0 |
0 |
0 |
0 |
0 |
26883 |
0.5 |
0 |
0 |
0 |
0 |
0 |
1 Four-tenths of a gram of a 75% w/w mixture of the test substance in a 1% w/w solution of CMC in distilled water was applied.
2 Hours after induction dose.
Table 4. Challenge phase skin reactions scores (test substance)
Animal No. |
Hours after Application |
|
24 |
48 |
|
26864 |
0.5 |
0 |
26865 |
0 |
0 |
26866 |
0 |
0 |
26867 |
0 |
0 |
26868 |
0.5 |
0 |
26869 |
0 |
0 |
26870 |
0 |
0 |
26871 |
0 |
0 |
26872 |
0 |
0 |
26873 |
0 |
0 |
26874 |
0 |
0 |
26875 |
0 |
0 |
26876 |
0 |
0 |
26877 |
0 |
0 |
26878 |
0 |
0 |
26879 |
0.5 |
0 |
26880 |
0 |
0 |
26881 |
0 |
0 |
26882 |
0.5 |
0 |
26883 |
0.5 |
0 |
Table 5. Challenge phase skin reactions
scores (test substance), naive control group
Animal No. |
Hours after Application |
|
24 |
48 |
|
26884 |
0.5 |
0 |
26885 |
0 |
0 |
26886 |
0 |
0 |
26887 |
0 |
0 |
26888 |
0 |
0 |
26889 |
0.5 |
0 |
26890 |
0 |
0 |
26891 |
0 |
0 |
26892 |
0 |
0 |
26893 |
0.5 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on these findings and on the evaluation system used, the test substance is not considered to be a contact sensitizer.
- Executive summary:
In a study performed in accordance with OECD TG 406 and GLP principles, a dermal sensitization test was conducted with guinea pigs to determine the potential of the test substance to produce sensitization after repeated topical applications. A 75% w/w mixture of the test substance in a 1% w/w solution of carboxymethylcellulose (CMC) in distilled water was topically applied to twenty guinea pigs, once each week for a three-week induction period. Twenty-seven days after the first induction dose, a challenge dose of the test substance at its highest non- irritating concentration (HNIC, determined in the preliminary irritation screen to be a 75% w/w mixture of the test substance in a 1% w/w solution of CMC in distilled water) was applied to a naive site on each guinea pig. A naive control group (ten animals) was maintained under the same environmental conditions and treated with the test substance at challenge only. Approximately 24 and 48 hours after each induction and challenge application the animals were scored for a sensitization response (erythema).
The test animals and naive control animals showed no incidences of positive response (scores greater than 0.5 after 24 and 48 hours. The test animals showed a severity of 0.13 and the naive control animals showed a severity of 0.15 ( Sum of the erythema scores divided by the number of animals evaluated).
Based on the results of this study, the test substance is not considered to be a contact sensitizer. The positive response observed in the historical positive control validation study with alpha-Hexylcinnamaldehyde Technical (HCA) validates the test system used in this study.
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