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EC number: 448-050-6 | CAS number: 444065-11-6
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 Jan - 04 Feb 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nousan, Notification No 8147, November 2000, including the most recent partial revisions
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 448-050-6
- EC Name:
- -
- Cas Number:
- 444065-11-6
- Molecular formula:
- C41 H57 N5 O8
- IUPAC Name:
- 2,6-di-tert-butyl-4-methylcyclohexyl 5-{[bis(2-ethoxy-2-oxoethyl)carbamoyl]oxy}-2-(4-tert-butylphenyl)-6-cyano-1H-pyrrolo[1,2-b][1,2,4]triazole-7-carboxylate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): UC-141
- Physical state: white powder
- Lot/batch No.: CE-203
- Expiration date of the lot/batch: 1 Jan 2005
- Storage condition of test material: at room temperature in the dark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Wistar Crl:(Wl) BR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: approximately 10 weeks
- Weight at study initiation: 347 ± 18 g (males, mean ± SD), 246 ± 15 g (females, mean ± SD)
- Housing: animals were individually housed in labelled Macrolon cages (type lII, height 15 cm) containing purified sawdust as bedding material (Woody-Clean type 3/4, Tecnilab-BMI B.V., Someren, the Netherlands)
- Diet: standard pelleted laboratory animal diet (Altromin (code VRF 1), Lage, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.6-22.9 (actual range)
- Humidity (%): 38-80 (actual range)
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 21 Jan 2004 To: 04 Feb 2004
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- propylene glycol
- Details on dermal exposure:
- TEST SITE
- Area of exposure: approximately 25 cm² in males and approximately 18 cm² in females
- % coverage: 10
- Type of wrap if used: the test substace was held in contact with the skin with a surgical gauze patch (Surgy 1 D), which was covered with aluminium foil and Coban elastic bandage. A piece of Micropore tape was used to secure the bandages in females only.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test substance was cleaned from the skin using water
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 mL/kg bw
- Constant volume or concentration used: yes
- Concentration (if solution): 200 mg/mL (w/w) (calculated from 10 mL/kg bw amount and 2000 mg/kg bw)
VEHICLE
- Amount(s) applied (volume or weight with unit): 10 mL/kg bw - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations of mortality were made twice daily; observations of clinical signs were made several times on Day 1 and daily thereafter, graded according to a severity scale of 1-4; weighing was performed weekly on Day 1 (pre-administration), 8 and 15
- Necropsy of survivors performed: yes, all gross pathological changes were recorded
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There was no mortality during the study period.
- Clinical signs:
- other: Systemic effects were observed on Day 1 from 2 hrs after administration until Day 6. Flat posture was observed in 3/5 males and 3/5 females from 2-4 hrs after dosing, while hunched posture was noted in 4/5 males and 5/5 females, generally with a later ons
- Gross pathology:
- Ther were no substance-related findings during necropsy and the gross pathological examination.
- Other findings:
- - Other observations: Mild local effects on the treated skin were seen throughout the study period. Erythema or erythema maculata was observed in 3/5 females on Day 3-5 and 3-4, respectively. Scales and/or scabs were seen in 1/5 males and 4/5 females for a total of 1-10 days between Day 5 and 15.
Any other information on results incl. tables
Table 1: Mortality and clinical signs
Dose |
Toxicological results* |
Duration of clinical signs |
Time of death |
Mortality (%) |
Males |
||||
2000 |
0/5/5 |
2 hrs on Day 1 – Day 13 |
- |
0 |
Females |
||||
2000 |
0/5/5 |
2 hrs on Day 1 – Day 15 |
- |
0 |
Overall LD50 > 2000 mg/kg bw |
* first number = number of dead animals
second number = number of animals with systemic clinical signs
third number = number of animals used
Table 2: Overview of clinical signs
Observations |
Males (reading time points) |
Females (Reading time points) |
||||||||
No. |
1 |
2 |
3 |
4 |
5 |
1 |
2 |
3 |
4 |
5 |
Systemic |
||||||||||
Hunched posture |
4 hrs, Day 1–Day 2 |
|
Day 2-3 |
Day 2-3 |
2 hrs, Day 1–Day 2 |
Day 2-5 |
4 hrs, Day 1–Day 6 |
Day 2-4 |
4 hrs, Day 1–Day 2 |
Day 2-3 |
Flat posture |
|
2-4 hrs, Day 1 |
2-4 hrs, Day 1 |
2-4 hrs, Day 1 |
|
|
|
2-4 hrs, Day 1 |
2 hrs, Day 1 |
4 hrs, Day 1 |
Chromodacryorrhoea (snout) |
2 hrs, Day 1 |
|
2 hrs, Day 1–Day 2 |
|
|
|
2 hrs, Day 1–Day 2 |
2 hrs, Day 1–Day 2 |
|
2-4 hrs, Day 1 |
Ptosis |
|
|
4 hrs, Day 1 |
|
|
|
|
|
|
|
Treated skin |
||||||||||
Scales |
|
|
|
Day 7-13 |
|
|
Day 7-8 |
Day 5-14 |
Day 6-8 |
Day 6-8 |
Scabs |
|
|
|
|
|
|
|
Day 9, 12-13 |
Day 15 |
|
General erythema (grade 1-4) |
|
|
|
|
|
|
Day 3 -5 (grade 1) |
Day 3-5 (grade 1) |
|
|
Erythema maculata (grade 1-4) |
|
|
|
|
|
|
|
|
|
Day 3-4 (grade 1) |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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.
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