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EC number: 238-523-3 | CAS number: 14516-71-3
- 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
![](https://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
Acute oral toxicity LD50: >2000 mg/kg bw (OECD 423, GLP)
Acute dermal toxicity LD50: >2000 mg/kg bw (OECD 402, GLP)
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19.06.2017 – 06.07.2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and batch No.of test material: Baoding 20161221
- Expiration date of the batch:20-12-2018
- Purity: 99.1%
- Purity test date: 21-12-2016
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Cool, dry area. - Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Breeding farm VELAZ s.r.o., Lysolaje, Czech Republic, RČH CZ 21760118
- Age at study initiation: 8 weeks
- Fasting: 20 hours
- Weight at study initiation: 152 - 188g
- Housing: Plastic breeding cage with shavings of soft wood
- Diet: Altromin for rats/mice, Manufacturer: Altromin Spezialfutter GmbH & Co. KG, Germany ad libitum
- Water: drinking water ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30 – 70 %
- Photoperiod (hrs dark / hrs light): light period 12-hour light/12 hour dark
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- VEHICLE
- Justification for choice of vehicle: The substance is insoluble in water
- Batch no. (if required): 8001526002 with expiration 02/2018 ( Dr. Kulich Pharma, s.r.o., Czech Republic)
Immediately before application the test substance was weighed, mixed with vehicle (Olive oil) and resulting suspension was administered to the stomach by tube. All prepared suspensions of the test substance in olive oil were mixed by magnetic stirrer during administration.
MAXIMUM DOSE VOLUME APPLIED: 1 mL/100 g
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: There was no information on the substance, so for animal welfare reasons a starting dose of 300 mg/kg body weight was used. - Doses:
- 300, 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Animals were weighed before application, at the 8th day of study and at the 15th day, before euthanasia of animals.
After application the animals were observed individually:
- the first day: twice (30 minutes and 3 hours after application)
- the second day: twice (in the morning and in the afternoon) and daily thereafter for 14 days.
Observations included changes in skin and fur, eyes, visible mucous membranes, behaviour of animals, somatomotor activity, reactions to stimuli, and presence of lacrimation, salivation and discharge from nostrils, function of respiratory, digestive and urogenital system.
- Necropsy of survivors performed: Yes; All test animals survived to the end of study were sacrificed on the 15th day and gross necropsy was carried out. Nutritious status, body surface, body foramina, thoracic, abdominal and cranial cavity were evaluated - Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- There were no mortalities at 300 or 2000 mg/kg bw.
- Clinical signs:
- other: No clinical signs of intoxication were detected at at 300 or 2000 mg/kg bw during the entire study
- Gross pathology:
- No pathologic macroscopic changes were diagnosed during pathological examination at at 300 or 2000 mg/kg bw.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an acute oral study (acute toxic class) in the rat, the LD50 (female) for UV-1084 was >2000 mg/kg bw.
- Executive summary:
In an acute oral toxicity study (17-468), groups of Wistar female rats (3/sex) were given single oral doses of UV-1084 (99.1%) in olive oil at doses of 300 and 2000 mg/kg bw and observed for 14 days.
LD50 (female): >2000 mg/kg bw.
The test substance administered at the doses of 300 or 2000 mg/kg did not cause death of any animals. There was no effect on body weights at any dose. No clinical signs of intoxication were detected during the entire study at any dose. No pathologic macroscopic changes were diagnosed during the pathological examination at any dose.
This acute oral study is classified as acceptable. It does satisfy the guideline requirement for an acute oral study (OECD 401) in the rat.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- There is one key study with a Klimisch score of 1. The quality of the database is high.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19.06.2017 – 06.07.2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and batch No.of test material: Baoding 20161221
- Expiration date of the batch:20-12-2018
- Purity: 99.1%
- Purity test date: 21-12-2016
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Cool, dry area. - Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Breeding farm VELAZ s.r.o., Lysolajské údolí 15/53, 165 00 Prague 6, Czech Republic, RČH CZ 11760500
- Weight at study initiation: 239-274 g (males); 224-247g (females)
- Housing: Plastic breeding cage with shavings of soft wood
- Diet: Altromin for rats/mice, Manufacturer: Altromin Spezialfutter GmbH & Co. KG, Germany ad libitum
- Water: drinking water ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30 – 70 %
- Photoperiod (hrs dark / hrs light): light period 12-hour light/12 hour dark - Type of coverage:
- semiocclusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: back of animal
- % coverage: about 6 x 6 cm (approx. 10 % of the body surface)
- Type of wrap if used: The application site was covered by a gauze and held in contact by plaster (strapping).
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes
- Time after start of exposure: 24 hrs
TEST MATERIAL
The amount of test substance for each animal was weighed out (according to its body weight and the dose) immediately before application. The test substance in delivered form was applied on the depilated area of skin. - Duration of exposure:
- 24 hrs
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
The animals were weighed at the start of the study (before application), at 8th day and at the end of experiment (15th day). The mean body weight of the groups was calculated from individual body weights. Body weight increments were calculated from the body weight at the start of the study, during the first week and at the end of the study.
After application, the animals were observed individually:
-the first day: twice (30 minutes and 3 hours after application)
-the second day: twice (in the morning and in the afternoon) and daily thereafter for 14 days.
Observations included changes in skin and fur, eyes, visible mucous membranes, behaviour of animals, somatomotor activity, reactions to stimuli, and presence of lacrimation, salivation and discharge from nostrils, function of respiratory, digestive and urogenital system.
- Necropsy of survivors performed: Yes; All test animals surviving to the end of study were sacrificed on the 15th day by diethyl ether narcosis and gross necropsy was carried out. Nutritional state, body surface, body foramina, thoracic, abdominal and cranial cavity were evaluated. - Preliminary study:
- The study was performed as a limit test: two groups of animals – 5 males and 5 females at a dose of 2000 mg/kg of body weight. The pre-test was performed with 1 male and 1 female from each group. After the end of exposure of these pilot animals, the other animals of the group were dosed..
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- The test substance applied at a dose of 2000 mg/kg of body weight did not cause death of any animals.
- Clinical signs:
- other: No clinical signs of toxicity were observed during the entire study.
- Gross pathology:
- No macroscopic changes were diagnosed during pathological examination.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an acute dermal toxicity study in rats, the LD50 of UV-1084 was >2000 mg/kg bw.
- Executive summary:
In an acute dermal toxicity study (17-459) groups of Wistar rats (5/sex) were dermally exposed (semi-occlusive) to UV-1084 (99.1%) for 24 hours. Animals were then observed for 14 days.
Dermal LD50 (Males/Females) = >2000 mg/kg bw
The test substance applied at a dose of 2000 mg/kg of body weight did not cause death of any animals. There were no effects on body weight throughout the study. No clinical signs of toxicity were observed during the entire study. No macroscopic changes were diagnosed during pathological examination.
This acute dermal study is classified as acceptable. It does satisfy the guideline requirement for an acute oral study (OECD 402) in the rat.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- There is one key study with a Klimisch score of 1. The quality of the database is high.
Additional information
There is one acute oral study in rats and one acute dermal study in rats.
Acute oral toxicity
In an acute oral toxicity study (OECD 423/GLP), groups of Wistar female rats (3/sex) were given single oral doses of UV-1084 (99.1%) in olive oil at doses of 300 and 2000 mg/kg bw and observed for 14 days.
The test substance administered at the doses of 300 or 2000 mg/kg did not cause death of any animals. There was no effect on body weights at any dose. No clinical signs of intoxication were detected during the entire study at any dose. No pathologic macroscopic changes were diagnosed during the pathological examination at any dose. The LD50 (female) was > 2000 mg/kg bw.
Acute dermal toxicity
In an acute dermal toxicity study (OECD 402/GLP) groups of Wistar rats (5/sex) were dermally exposed (semi-occlusive) to UV-1084 (99.1%) for 24 hours. Animals then were observed for 14 days.
The test substance applied at a dose of 2000 mg/kg of body weight did not cause death of any animals. There were no effects on body weight throughout the study. No clinical signs of toxicity were observed during the entire study. No macroscopic changes were diagnosed during pathological examination. The dermal LD50 (males/females) = >2000 mg/kg bw.
The results from these studies are acceptable to use in the human health hazard assessment.
Justification for classification or non-classification
Based on the available information in the dossier, the substance UV-1084 (CAS No. 14516-71-3) does not need to classified for acute toxicity or specific target organ toxicity - single exposure when the criteria outlined in Annex I of 1272/2008/EC are applied.
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.
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