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EC number: 288-897-7 | CAS number: 85940-09-6
- 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
Endpoint summary
Administrative data
Description of key information
In an acute oral toxicity study in rats the acute oral LD50 was determined to be > 2000 mg/kg bw.
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:
- 11 May 2017 - 05 July 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)
- Version / remarks:
- 2001 December 17th
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- 31 May 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Crl:WI rats
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Source: TOXI COOP ZRT. Cserkesz u. 90., 1103 Budapest, Hungary
Hygienic level at arrival: SPF
Hygienic level during the study: Good conventional
Justification of strain: The Wistar rat as a rodent is one of the standard species of acute toxicity studies
Number of animals: 3 animals/group
Sex: Female, nulliparous and non pregnant animals
Age of animals: Young adult rat, 8 weeks old in the first and second step
Body weight range at starting (first step): 173 - 173 g
Body weight range at starting (second step): 197 - 200 g
Acclimatization time: 6 days in the first step and 7 days in the second step
Husbandry
Animal health: Only healthy animals were used for the study. Health status was certified by the study director.
Room: 13/2
Housing: Group caging (3 animals/cage)
Cage type: Type III. polypropylene/polycarbonate.
Bedding: Laboratory bedding.
Light: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Temperature: 22 ± 3 °C
Relative humidity: 30 - 70 %
Ventilation: above 10 air exchanges/hour by central air-condition system.
The temperature and relative humidity were recorded daily during the study.
Food and Water Supply
Animals received ssniff® SM R/M-Z+H complete diet for rats and mice produced by ssniff Spezialdiäten GmbH, D-59494 Soest Germany and tap water from municipal supply, as for human consumption from bottle ad libitum. The diet and drinking water are periodically analysed and are considered not to contain any contaminants that could reasonably be expected to affect the purpose or integrity of the study. - Route of administration:
- oral: gavage
- Vehicle:
- vegetable oil
- Remarks:
- Helianthi annui oleum raffinatum
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6 females/dose (3 females/step)
- Control animals:
- no
- Details on study design:
- Duration of observation period after the treatment: 14 days.
Frequency of observations:
Animals were observed individually after dosing at least once during the first 30 minutes, then 1 h, 2 h, 3 h, 4 h after the treatment and twice each
day for 14 days thereafter.
Body weight measurement:
The body weights were recorded on day 0 (just before the treatment), on day 7 and on day 15 with a precision of 1 g.
Necropsy:
At the end of the observation period all surviving rats were necropsied. - Statistics:
- No statistics was used in the study.
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No lethality was noted at a single oral dose of 2000 mg/kg bw.
- Clinical signs:
- other: In the first and second step, dark faeces were observed in all animals on Day 1, being related to the physical property of the test item. No systemic clinical symptoms were observed on the day of the treatment and during the 14-day observation period, the
- Gross pathology:
- All organs of the animals treated with 2000 mg/kg bw proved to be free of treatment related gross pathological changes.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral LD50 was determined to be > 2000 mg/kg bw.
- Executive summary:
An acute oral toxicity study was performed according to OECD guideline 423. The acute toxic class method was carried out involving a stepwise procedure with the use of 2000 mg/kg bw as the starting dose in three female rats. No animal died in the first step at 2000 mg/kg bw dose level, so treatment with 2000 mg/kg bw was repeated on further three female rats. No animal died in the second step, too, so the test was finished, the stopping criteria of Annex 2d of OECD Guideline No. 423 were met. Animals were weighed, observed for lethality and toxic symptoms for 14 days after the treatment. Gross pathological examination was carried out on the 15th day after the treatment.
No lethality was noted at a single oral dose of 2000 mg/kg bw. In the first and second step, dark faeces were observed in all animals on Day 1, being related to the physical property of the test item. No systemic clinical symptoms were observed on the day of the treatment and during the 14-day observation period, the general state and behaviour of the experimental animals were normal. The body weight development was not affected in all animals. All organs of the animals treated with 2000 mg/kg bw proved to be free of treatment related gross pathological changes. The method used is not intended to allow the calculation of a precise LD50 value. The acute oral LD50 was determined to be > 2000 mg/kg bw.
Reference
Summary of Lethality: Post-treatment observation period (14 days)
Groups |
Treatment |
Lethality |
|
Test Item |
Dose |
Females |
|
1 |
Step 1 |
2000 |
0/3 |
2 |
Step 2 |
2000 |
0/3 |
Summary of Clinical Symptoms
Groups |
Treatment |
Symptoms |
Incidence |
|
Test Item |
Dose |
|||
1 |
Step 1 |
2000 |
Dark faeces |
3/57 |
Normal |
54/57 |
|||
2 |
Step 2 |
2000 |
Dark faeces |
3/57 |
Normal |
54/57 |
Remark: Incidence = Number of symptoms/Summarized number of observations inside the group
Summarized
number of observations inside the group = (number
of observations of first animal) + (number of observations of second
animal) +
(number of observations of third animal)
Summary of Body Weights (g)
FEMALES |
|
Day 0 |
Day 7 |
Day 15 |
|
|
|
|
|
Group 1: |
||||
2000 mg/kg bw, Step 1 |
|
|
|
|
|
|
|
|
|
Group size: |
|
3 |
3 |
3 |
Mean: (g) |
|
173.0 |
206.7 |
243.3 |
SD: |
|
0.00 |
4.73 |
20.50 |
|
|
|
|
|
FEMALES |
|
Day 0 |
Day 7 |
Day 15 |
|
|
|
|
|
Group 2: |
||||
2000 mg/kg bw, Step 2 |
|
|
|
|
|
|
|
|
|
Group size: |
|
3 |
3 |
3 |
Mean: (g) |
|
198.3 |
226.3 |
238.7 |
SD: |
|
1.53 |
8.08 |
12.50 |
|
|
|
|
|
Summary of Body Weight Gains (g)
FEMALES |
|
Day 0-7 |
Day 7-15 |
Day 0-15 |
|
|
|
|
|
Group 1: |
||||
2000 mg/kg bw, Step 1 |
||||
Group size: |
|
3 |
3 |
3 |
Mean: (g) |
|
33.7 |
36.7 |
70.3 |
SD: |
|
4.73 |
15.95 |
20.50 |
|
|
|
|
|
FEMALES |
|
Day 0-7 |
Day 7-15 |
Day 0-15 |
|
|
|
|
|
Group 2: |
||||
2000 mg/kg bw, Step 2 |
|
|
|
|
Group size: |
|
3 |
3 |
3 |
Mean: (g) |
|
|
|
|
SD: |
|
28.0 |
12.3 |
40.3 |
|
|
8.89 |
4.73 |
13.05 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Acute oral toxicity:
An acute oral toxicity study was performed according to OECD guideline 423. The acute toxic class method was carried out involving a stepwise procedure with the use of 2000 mg/kg bw as the starting dose in three female rats. No animal died in the first step at 2000 mg/kg bw dose level, so treatment with 2000 mg/kg bw was repeated on further three female rats. No animal died in the second step, too, so the test was finished, the stopping criteria of Annex 2d of OECD Guideline No. 423 were met. Animals were weighed, observed for lethality and toxic symptoms for 14 days after the treatment. Gross pathological examination was carried out on the 15th day after the treatment.
No lethality was noted at a single oral dose of 2000 mg/kg bw. In the first and second step, dark faeces were observed in all animals on Day 1, being related to the physical property of the test item. No systemic clinical symptoms were observed on the day of the treatment and during the 14-day observation period, the general state and behaviour of the experimental animals were normal. The body weight development was not affected in all animals. All organs of the animals treated with 2000 mg/kg bw proved to be free of treatment related gross pathological changes. The method used is not intended to allow the calculation of a precise LD50 value. The acute oral LD50 was determined to be > 2000 mg/kg bw.
Acute inhalation toxicity:
The study does not need to be conducted as exposure of humans via inhalation is not the appropriate route of exposure. Furthermore, physicochemical and toxicological properties do not suggest a potential for a significant rate of respiratory absorption.
Acute dermal toxicity:
According to REACH Annex VIII point 8.5.3 the study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation).
Justification for classification or non-classification
Classification, Labelling, and Packaging
Regulation (EC) No 1272/2008
The available experimental test
data are reliable and suitable for classification purposes under
Regulation (EC) No 1272/2008. Based on available data on acute
oraltoxicity, the test item is not classified according to Regulation
(EC) No 1272/2008 (CLP), as amended for the twelfth time in
Regulation (EU) No 2019/521.
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