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EC number: 279-510-2 | CAS number: 80584-99-2
- 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
Endpoint summary
Administrative data
Description of key information
In an acute dermal toxicity study according to OECD 402, groups of young adult Wister rats (5 male/ 5 female) were dermally exposed to VOELOFA Monomer (100% purity) for 4 hours at a limit dose of 2000 mg/kg bw and were observed for 14 days. Based on the results, the target substance does not require classification for acute toxicity according to CLP criteria. In an acute oral toxicity study according to OECD 423, two groups of fasted, 8-12 weeks old female Wistar rats (3 rats/ group) were given a single oral dose of VOELOFA Monomer (100% purity) at the limit dose of 2000 mg/kg bw and were observed for 14 days. Based on the results, the target substance does not require classification for acute toxicity according to CLP criteria.
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:
- 2016-07-21 to 2016-10-17
- 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:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Velaz Prague, Czech Republic
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 185-200g
- Fasting period before study: food was withheld over-night (but not water).
- Housing: plastic cages suspended on stainless steel racks, up to 3 animals per cage.
- Diet (e.g. ad libitum): laboratory food ssniff (Spezialdiäten GmbH, Germany), in recommended doses each day approximately at the same time.
- Water (e.g. ad libitum): tap water for human consumption (unlimited), quality of drinking water is periodical analysed.
- Acclimation period: 5 days prior to the start of treatment.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.4 ± 0.4 °C
- Humidity (%): 55.3 ± 4.0%
- Air changes (per hr): central air conditioning
- Photoperiod (hrs dark / hrs light): 12-hour light/12-hour dark cycle - Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- VEHICLE
- Justification for choice of vehicle: Olive oil is a standard vehicle according to OECD TG 423.
- Lot/batch no. (if required): L52897, Expiry Date: 04/2017
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Available information indicated that the test item is likely to be nontoxic with regard to acute toxicity. - Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 3 females per step, 2 steps performed
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical observation was made immediately after administration of the test item and 0.5, 1, 2, and 4 hours later. Thereafter, the animals were observed for clinical signs daily. Weighing was performed shortly before administration of the test item and weekly thereafter.
- Necropsy of survivors performed: yes, all test animals were subjected to gross necropsy. Full, detailed gross necropsy included examination of external surface of the body, all orifices, and cranial, thoracic and abdominal cavities and their contents.
- Other examinations performed: Clinical observations included changes in skin, fur, eyes and mucous membranes, respiratory, circulatory, autonomic and central nervous systems, and somatomotor activity and behaviour pattern. Attention was directed to observations of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma. - Statistics:
- N.A.
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed during the study.
- Clinical signs:
- other: No change of health and no negative reactions were registered. Animals lived through observation period without signs of intoxication.
- Gross pathology:
- No macroscopically findings were noticed, during necropsy.
- Other findings:
- N.A.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an acute oral toxicity study in rats according to OECD 423, no adverse effects were observed for the test item VOELOFA Monomer at the limit dose of 2000 mg/kg bw. Hence, the LD50 value is determined to be greater than 2000 mg/kg bw.
- Executive summary:
In an acute ora ltoxicity study (acute toxic class method, OECD 423), two groups of fasted, 8-12 weeks old female Wistar rats (3 rats/ group) were given a single oral dose of VOELOFA Monomer (100% purity) in olive oil at the limit dose of 2000 mg/kg bw and were observed for 14 days.
Oral LD50Females = > 2000 mg/kg bw
No mortality was observed during the study. Animals lived through observation period without signs of intoxication. Throughout the 14-day observation period, no body weight losses were observed. At necropsy, no macroscopically findings were noticed. Based on the results from this study, the oral LD50 in rats is considered to be greater than 2000 mg/kg bw.
Reference
Table 1: Body Weight
Sex |
Dose |
ID |
Body Weight(g) |
Body Weight Difference (g) |
||||
Initial |
Week1 |
Week2 |
Week 1 -Initial |
Week 2 -Initial |
Week 2 - Week1 |
|||
♀ |
2000 mg/kg |
1 |
200 |
220 |
225 |
20 |
25 |
5 |
2 |
190 |
220 |
230 |
30 |
40 |
10 |
||
3 |
195 |
220 |
235 |
25 |
40 |
15 |
||
4 |
190 |
220 |
250 |
30 |
60 |
30 |
||
5 |
185 |
230 |
235 |
45 |
50 |
5 |
||
6 |
185 |
200 |
230 |
15 |
45 |
30 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- Guideline study
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:
- 2016-07-22 to 2016-10-17
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- adopted, 24 February 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 434 (Acute Dermal Toxicity - Fixed Dose Procedure)
- Version / remarks:
- Proposal for a New Draft Guideline 434, May 2004
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Velaz Prague, Czech Republic
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8-12 weeks
- Weight at study initiation: females 190-210 g; males: 220-260 g
- Fasting period before study: no
- Housing: The animals were housed in plastic cages suspended on stainless steel racks, up to 2-3 animals per cage, males and females separately in a room equipped with central air-conditioning. The sanitation was performed according to the standard operation procedures. Bedding: Lignocel S3/4, Lufa - ITL GmbH, Germany
- Diet (e.g. ad libitum): laboratory food ssniff (ssniff Spezialdiäten GmbH), offered in recommended doses each day approximately at the same time
- Water (e.g. ad libitum): unlimited supply of tap water for human consumption (periodical analysis of the quality, including microbiological control)
- Acclimation period: at least 5 days prior to the start of treatment (according to standard operation procedures)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.4 ± 0.4 °C
- Humidity (%): 55.3 ± 4%.
- Air changes (per hr): central air-conditioning
- Photoperiod (hrs dark / hrs light): 12-hour light/ 12-hour dark cycle - Type of coverage:
- semiocclusive
- Vehicle:
- olive oil
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: 10%
- Type of wrap if used: Cosmopor E and a semi-occlusive dressing with non-irritating tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): removing using lukewarm water
- Time after start of exposure: 24h (at the end of the exposure period of 24 h)
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): limit dose of 2000 mg/kg body weight (single application)
- For solids, paste formed: no
VEHICLE
Olive Oil (Oleificio Luca, Italy, lot no.: L52897, expiry date 04/2017) is a standard vehicle according to OECD TG 423. - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 5 male and 5 female
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: 0.5, 1, 2, and 4 hours after application and daily thereafter
- Frequency of weighing: determined shortly before the test item was applied and weekly thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: Observations included changes in skin and fur, eyes and mucous membranes, and also respiratory, circulatory, autonomic and central nervous systems, and somatomotor activity and behaviour pattern. Attention was directed to observations of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma. - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50 cut-off
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- no indication of skin irritation up to the relevant limit dose level
- Mortality:
- No mortality was observed during the study.
- Clinical signs:
- other: Animals lived through observation period without signs of intoxication. Neither change of health nor negative reactions were registered.
- Gross pathology:
- All animals (5 females and 5 males) were necropsied. During necropsy, no macroscopic changes were noticed.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In conclusion, in an acute dermal toxicity study according to OECD 402 and OECD Guidline Draft 434, single dermal application of the test item VOELOFA Monomer to rats at a limit dose of 2000 mg/kg bw was associated with no mortality. Animals lived through observation period without signs of intoxication. Neither change of health nor negative reactions were registered.
- Executive summary:
In an acute dermal toxicity study according to OECD 402, groups of young adult Wister rats (5 male/ 5 female) were dermally exposed to VOELOFA Monomer (100% purity) in olive oil for 4 hours to 10% of the total body surface area at a dose of 2000 mg/kg bw. Animals then were observed for 14 days.
Dermal LD50 Males >2000 mg/kg bw
Females > 2000 mg/kg bw
The study was performed as a limit test. No mortality occurred during the test period. There were no treatment related clinical signs, necropsy findings or changes in body weight.
According to the present study, VOELOFA Monomer does not require classification for acute toxicity according to CLP criteria.
Reference
Table 1: Body Weight
Sex |
Dose |
ID |
Body Weight (g) |
Body Weight Difference (g) |
||||
Initial |
Week 1 |
Week 2 |
Week 1 -Initial |
Week 2 -Initial |
Week 2 - Week 1 |
|||
♀ |
2000 mg/kg |
1 |
200 |
220 |
245 |
20 |
45 |
25 |
2 |
190 |
200 |
215 |
10 |
25 |
15 |
||
3 |
210 |
220 |
240 |
10 |
30 |
20 |
||
4 |
210 |
230 |
240 |
20 |
30 |
10 |
||
5 |
200 |
230 |
240 |
30 |
40 |
10 |
||
♂ |
2000 mg/kg |
6 |
260 |
330 |
370 |
70 |
110 |
40 |
7 |
250 |
300 |
340 |
50 |
90 |
40 |
||
8 |
240 |
300 |
340 |
60 |
100 |
40 |
||
9 |
250 |
320 |
370 |
70 |
120 |
50 |
||
10 |
220 |
260 |
305 |
40 |
85 |
45 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- Guideline study
Additional information
VOELOFA Monomer (100% purity) was tested negative for acute dermal toxicity in a study conducted according to OECD Guideline 402. No mortality occurred during the test period. There were no treatment related clinical signs, necropsy findings or changes in body weight.
VOELOFA Monomer (100% purity) was tested negative for acute oral toxicity in a study conducted according to OECD Guideline 423. No mortality occurred during the test period. There were no treatment related clinical signs, necropsy findings or changes in body weight.
Based on the results, the oral and dermal LD50 can be considered to exceed 2000 mg/kg bw.
Justification for classification or non-classification
Based on the available results, no classification is warranted for acute toxicity in accorandance to CLP Regulation 1272/2008. The oral and dermal LD50 value was above the limit value of the relevant OECD guideline.
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