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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 928-729-8 | CAS number: 188416-20-8
- 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:
- From 15 to 25 July 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study run to a method comparable with current guidelines and to GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3-(6-chloro-5-fluoropyrimidin-4-yl)-2-(2,4-difluorophenyl)-1-(1H-1,2,4-triazol-1-yl)butan-2-ol hydrochloride
- EC Number:
- 928-729-8
- Cas Number:
- 188416-20-8
- Molecular formula:
- C16H13ClF3N5O.HCl
- IUPAC Name:
- 3-(6-chloro-5-fluoropyrimidin-4-yl)-2-(2,4-difluorophenyl)-1-(1H-1,2,4-triazol-1-yl)butan-2-ol hydrochloride
- Details on test material:
- Batch No.: 5ABJ002
Purity: 90%
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Obtained from Harlan UK Ltd
- Age at study initiation: Approximately 10 to 12 weeks.
- Weight at study initiation: 2.4 to 2.6 kg
- Housing: Test animals were housed individually in stainless steel cages with perforated floors.
- Diet (e.g. ad libitum): A standard laboratory rabbit diet (Special Diet Services STANRAB (P) SQC pellet)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: six days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5 to 24
- Humidity (%): 34 - 59
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To:
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Approximately 0.5 g
- Concentration (if solution):
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 ml distilled water
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity: - Duration of treatment / exposure:
- First animals: The test substance was applied to three treatment sites and the exposure period was varied between treatment sites (ie three minutes, 60 minutes and four hours).
The remaining two animals: Four hours exposure period. - Observation period:
- 10 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: approximately 100mm*100mm
- % coverage:
- Type of wrap if used: Each treatment site was covered with "Elastoplast" elastic adhesive dressing.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treatment sites washed with warm water to remove any residual test substance.
- Time after start of exposure: three minutes, 60 minutes and four hours
SCORING SYSTEM:
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- ca. 1.44
- Max. score:
- 2
- Reversibility:
- fully reversible within: 9 days
- Remarks on result:
- other: The exposure period is 4 hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- ca. 0.22
- Max. score:
- 1
- Reversibility:
- fully reversible within: 2 days
- Remarks on result:
- other: The exposure period is 4 hours
- Irritant / corrosive response data:
- No dermal respose to treatment was observed following the three minute exposure.
Well-defined erythema only was seen following the one hour exposure.
Well-defined erythema with or without very slight oedma was seen in all animals following the four hour exposure. These reactions were accompanied in one rabbit by desquamation of the stratumn corneum (characterised by dryness and sloughing of skin). Reactions had resolved in all animals by Day 7, 8 or 10.
Any other information on results incl. tables
There were no signs of toxicity or ill health in any rabbit during the observation period.
Animal No. & Sex |
Exposure Time |
E=Erythema O=Oedema |
Day |
|||||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
|||
1011 Female* |
3 Minutes |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
|
|
1 Hour |
E O |
0 0 |
2 0 |
2 0 |
1 0 |
1 0 |
1 0 |
1 0 |
0 0 |
|
|
|
4 Hours |
E O |
2 0 |
2 0 |
2 0 |
1 0 |
1 0 |
1 0 |
1 0 |
0 0 |
|
|
|
1012 Female |
4 Hours |
E O |
1 0 |
2 1 |
1 0 |
1 0 |
1 0 |
1 0 |
0 0 |
|
|
|
1013 Female |
4 Hours |
E O |
1 0 |
2 1 |
1 0 |
1 0 |
1 0 |
1 0 |
1 0 |
1a 0 |
1a 0 |
0 0 |
* Screen animal
a Desquamation of the stratum corneum (characterised by dryness and sloughing of skin)
Applicant's summary and conclusion
- Interpretation of results:
- moderately irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- A single semi-occlusive application of this substance to intact rabbit skin for up to four hours elicited well-defined dermal irritation.
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.