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EC number: 441-100-8 | CAS number: 351197-46-1
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 May - 11 Jun 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- incl. certificate for RCC Ltd 4452 Itingen from Swiss Federal Office of Public Health
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 441-100-8
- EC Name:
- -
- Cas Number:
- 351197-46-1
- Molecular formula:
- Hill formula: C24 H48 N4 O6 CAS formula: C24 H48 O6 N4
- IUPAC Name:
- 2-[2-(dimethylamino)ethoxy]ethyl N-{[1,3,3-trimethyl-5-(9-methyl-2-oxo-3,6-dioxa-1,9-diazadecan-1-yl)cyclohexyl]methyl}carbamate
- Details on test material:
- - Name of test material (as cited in study report): UAX-1179
- Physical state / appearence: pale, amber liquid
- Analytical purity: >99% proprietary tertiary amines
- Density: approx. 1.05 g/mL
- Lot/batch No.: M. 17-08.01
- Expiration date of the lot/batch: 19-Sep-2003
- Storage condition of test material: In the original container, at room temperature (range of 20 +/- 3 °C), away from direct sunlight, heat and moisture. The sample is to be stored under dry air (nitrogen).
- Safety Precautions: Routine hygienic procedures were used to ensure the health
and safety of the personnel
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: HanBrl: WIST (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: RCC Ltd, Biotechnology and Animal Breeding Division, CH-4414 Fiillinsdorf / Switzerland
- Age at study initiation: Males: 9 weeks, Females: 12 weeks
- Weight at study initiation: range 185.4 - 258.3 g
- Housing: During acclimatization in groups of five per sex in Makrolon type-4 cages with standard softwood bedding. Individually in Makrolon type-3 cages with standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz) during treatment and observation.
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet, batch no. 1/02 (Provimi Kliba AG, CH- 4303 Kaiseraugsv Switzerland) ad libitum. Results of analyses for contaminants are archived at RCC Ltd, Itingen.
- Water (e.g. ad libitum): Community tap water from Fijllinsdorf ad libitum. Results of bacteriological, chemical and contaminant analyses are archived at RCC Ltd, Itingen.
- Acclimation period: one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 30 - 70%
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12
- music during the light period
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- other: none
- Details on dermal exposure:
- TEST SITE
- Area of exposure: on the back
- % coverage: 10% of the total body surface
- Type of wrap if used: The dressing was wrapped around the abdomen and fixed with an elastic adhesive bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): flushed with lukewarm water
- Time after start of exposure: 24 hours after the application
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.9 mL (x 1.05 g/mL = 2000 mglkg)
VEHICLE
- undiluted - 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 weighing: On test days 1 (prior to administration), 8 and 15.
- Frequency of observations (Mortality / Viability): Daily during acclimatization and twice daily during days 1-15.
- Frequency of observations (Clinical signs): Daily during acclimatization and at approximately 1, 2, 3 and 5 hours after administration on test day 1. Once daily during days 2-15. All abnormalities were recorded.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopic examinations - Statistics:
- No statistical analysis was used.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0 Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
No deaths occured during the study. - Clinical signs:
- other: Signs of toxicity related to dose levels: No systemic signs of toxicity were observed during the study.
- Gross pathology:
- No macroscopic findings were observed at necropsy.
- Other findings:
- Signs of toxicity (local): Slight erythema was observed in all male and female animals from test day 2 after removal of the dressing to test day 5 and persisted until test day 6 in two male animals until test day 9 in one male and three female animals.
Any other information on results incl. tables
The median lethal dose of UAX-1179 after single dermal administration to rats of both sexes,
observed over a period of 14 days is:
LD50 (rat): > 2000 mg/kg body weight
Table 1: Body weights (in grams)
Sex / Dose |
Animal. No. |
Day of Treatment |
Day 8 |
Day 15 |
male / 2000 mg/kg |
1 |
257.7 |
271.4 |
296.8 |
2 |
255.9 |
283.7 |
309.2 |
|
3 |
253.0 |
261.2 |
290.9 |
|
4 |
258.3 |
273.4 |
301.5 |
|
5 |
239.9 |
256.0 |
277.5 |
|
female / 2000 mg/kg |
6 |
207.0 |
205.6 |
217.3 |
7 |
205.2 |
206.9 |
208.0 |
|
8 |
199.4 |
214.6 |
215.6 |
|
9 |
194.9 |
198.7 |
199.0 |
|
10 |
185.4 |
193.3 |
196.5 |
Table 2: Clinical / Local signs
|
|
|
Test day |
|||||||||||
Sex / Dose |
Animal No. |
Signs |
1
|
2 |
3 |
4 |
5 |
6 |
7 |
8-9 |
10-15 |
|||
1* |
2* |
3* |
5* |
|||||||||||
male / 2000 mg/kg |
1 |
No clinical signs |
/ |
/ |
/ |
/ |
|
|
|
|
|
|
|
/ |
Erythema |
- |
- |
- |
- |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
||
2 |
No clinical signs |
/ |
/ |
/ |
/ |
|
|
|
|
/ |
/ |
/ |
/ |
|
Erythema |
- |
- |
- |
- |
1 |
1 |
1 |
1 |
|
|
|
|
||
3 |
No clinical signs |
/ |
/ |
/ |
/ |
|
|
|
|
|
/ |
/ |
/ |
|
Erythema |
- |
- |
- |
- |
1 |
1 |
1 |
1 |
1 |
|
|
|
||
4 |
No clinical signs |
/ |
/ |
/ |
/ |
|
|
|
|
/ |
/ |
/ |
/ |
|
Erythema |
- |
- |
- |
- |
1 |
1 |
1 |
1 |
|
|
|
|
||
5 |
No clinical signs |
/ |
/ |
/ |
/ |
|
|
|
|
|
/ |
/ |
/ |
|
Erythema |
- |
- |
- |
- |
1 |
1 |
1 |
1 |
1 |
|
|
|
||
female / 2000 mg/kg |
6 |
No clinical signs |
/ |
/ |
/ |
/ |
|
|
|
|
/ |
/ |
/ |
/ |
Erythema |
- |
- |
- |
- |
1 |
1 |
1 |
1 |
|
|
|
|
||
7 |
No clinical signs |
/ |
/ |
/ |
/ |
|
|
|
|
/ |
/ |
/ |
/ |
|
Erythema |
- |
- |
- |
- |
1 |
1 |
1 |
1 |
|
|
|
|
||
8 |
No clinical signs |
/ |
/ |
/ |
/ |
|
|
|
|
|
|
|
/ |
|
Erythema |
- |
- |
- |
- |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
||
9 |
No clinical signs |
/ |
/ |
/ |
/ |
|
|
|
|
|
|
|
/ |
|
Erythema |
- |
- |
- |
- |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
||
10 |
No clinical signs |
/ |
/ |
/ |
/ |
|
|
|
|
|
|
|
/ |
|
Erythema |
- |
- |
- |
- |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
1 slight, / noted, - semi-occlusive dressing present; no reading of the local signs
*Examination performed approximately 1,2,3 and 5 hours after treatment.
No clinical signs were evident in any animal during the acclimatization period.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 of UAX-1179 after dermal application to rat is > 2000 mg/kg body weight.
- Executive summary:
After dermal application of 2000 mg/kg bw of the undiluted test item for 24 hours, no deaths occurred during the GLP-Guideline study. Slight erythema was observed in all animals. The median lethal dose of UAX-1179 after a single dermal administration to rats of both sexes, observed over a period of 14 days is greater than 2000 mg/kg body weight.
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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