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EC number: 263-160-2 | CAS number: 61790-69-0
- 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 a GLP-compliant acute oral toxicity study according to OECD Guideline 423, no mortality occurred and no clinical signs were seen at the limit dose of 2000 mg/kg bw. Therefore, the oral LD50 was calculated to be greater than 2000 mg/kg bw in rats.
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:
- Mar - Apr 2018
- 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:
- December 17, 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- 2002
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- (from the competent authority) Landesanstalt für Umwelt Baden-Württemberg
- Test type:
- acute toxic class method
- Limit test:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch No.of test material: 0017319511
- Expiration date of the batch: December 18, 2018
- Purity: > 99 %
- Physical state / color: Solid, waxy / white to yellowish
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Stability under test conditions: The homogeneity of the test item preparation during administration was ensured by stirring with a magnetic stirrer.
- Solubility and stability of the test substance in the solvent/vehicle: good homogeneity in corn oil Ph.Eur.
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: For better handling the test item was heated at approx. 50 °C. The test item preparation was prduced for each administration group shortly before administration with a spatula and by stirring with a magnetic stirrer. The test item preparation was administere lukewarm.
FORM AS APPLIED IN THE TEST (if different from that of starting material) : suspension - Species:
- rat
- Strain:
- Wistar
- Remarks:
- Crl:WI (Han) SPF
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH; Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: young adult animals (female animals approx. 10 weeks)
- Weight at study initiation: animals of comparable weight (± 20 % of the mean weight)
- Fasting period before study: Feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum.
- Housing: single housing in fully air-conditioned rooms
- Diet (e.g. ad libitum): VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany, ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: At least 5 days before the beginning of the experimental phase
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 °C ± 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12 h / 12 h - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Remarks:
- Ph.Eur.
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 40 g/100 mL
- Amount of vehicle (if gavage): 5.00 mL/kg bw
- Justification for choice of vehicle: Good homogeneity in corn oil Ph.Eur.
MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg bw
DOSAGE PREPARATION (if unusual): For better handling the test item was heated at approx. 50 °C. The test item preparation was produced for each administration group shortly before administration with a spatula and by stirring with a magnetic stirrer. The test item preparation was administered lukewarm.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: By request of the sponsor a starting dose of 2000 mg/kg bw was chosen in the first step with 3 female animals. Because no mortality occurred, a further dose of 2000 mg/kg bw was administered to another group of 3 female animals in the second step. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Individual body weights shortly before administration (day 0), weekly thereafter and on the last day of observation. Clinical signs for each animal were recorded several times on the day of administration and at least once during each workday thereafter. A check for any dead or moribund animals was made at least once each workday.
- Necropsy of survivors performed: yes - Statistics:
- Calculations were performed using Microsoft Excel 2010 and checked with a calculator.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no mortality occurred
- Mortality:
- No mortality occurred in both 2000 mg/kg bw test groups.
- Clinical signs:
- other: No clinical signs were observed during clinical examination in both 2000 mg/kg bw test groups.
- Gross pathology:
- There were no macroscopic pathological findings in any animal sacrificed at the end of the observation period (6 females).
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study the median lethal dose of the test substance after oral administration was found to be greater than 2000 mg/kg bw in rats.
- Executive summary:
In an acute oral toxicity study performed according to the Acute Toxic Class Method, a dose of 2000 mg/kg bw of the test item (preparations in corn oil Ph.Eur.) was administered by gavage to two test groups of three fasted Wistar rats each.
2000 mg/kg (both test groups):
- No mortality occurred
- No clinical signs were observed
- All animals gained weight in a normal range throughout the study period
- There were no macroscopic pathological findings in any animal sacrificed at the end of the observation period (6 females)
The acute oral LD50 was calculated to be greater than 2000 mg/kg bw in rats.
Reference
Table 1: Mortality
Dose [mg/kg bw] |
2000 |
2000 |
Sex |
Female |
Female |
Administration |
1 |
2 |
No. of animals |
3 |
3 |
Mortality (animals) |
No mortality |
No mortality |
Table 2: Maximum incidence of clinical signs
Dose [mg/kg bw] |
2000 |
2000 |
||||
Sex |
Female |
Female |
||||
Administration |
1 |
2 |
||||
No. of animals |
3 |
3 |
||||
Animal No. |
R 151 |
R 152 |
R 153 |
R 154 |
R 155 |
R 156 |
Abnormalities |
- |
- |
- |
- |
- |
- |
Table 3: Body weights
Dose [mg/kg bw] |
2000 |
2000 |
||||||||
Administration |
1 |
2 |
||||||||
Animal No. |
R 151 |
R 152 |
R 153 |
Mean weight |
Standard deviation |
R 154 |
R 155 |
R 156 |
Mean weight |
Standard deviation |
Body weight at study day [g] |
|
|||||||||
0 |
178 |
176 |
168 |
174.0 |
5.29 |
179 |
173 |
169 |
173.7 |
5.03 |
7 |
200 |
193 |
183 |
192.0 |
8.54 |
200 |
189 |
191 |
193.3 |
5.86 |
14 |
215 |
195 |
189 |
199.7 |
13.61 |
207 |
198 |
207 |
204.0 |
5.20 |
Table 4: Gross pathology
Dose [mg/kg bw] |
2000 |
2000 |
||||
Administration |
1 |
2 |
||||
No. of animals |
3 |
3 |
||||
Animal No. |
R 151 |
R 152 |
R 153 |
R 154 |
R 155 |
R 156 |
Macroscopic pathologic abnormalities |
- |
- |
- |
- |
- |
- |
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
In an acute oral toxicity study performed according to the Acute Toxic Class Method, a dose of 2000 mg/kg bw of the test item (preparations in corn oil Ph.Eur.) was administered by gavage to two test groups of three fasted Wistar rats each.
2000 mg/kg (both test groups):
- No mortality occurred
- No clinical signs were observed
- All animals gained weight in a normal range throughout the study period
- There were no macroscopic pathological findings in any animal sacrificed at the end of the observation period (6 females)
The acute oral LD50 was calculated to be greater than 2000 mg/kg bw in rats.
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 1272/2008. No mortality occurred at the limit dose of 2000 mg/kg bw. As a result, the substance is not considered to be classified for acute oral toxicity under Regulation (EC) No. 1272/2008, as amended for the tenth time in Regulation (EC) No. 2017/776.
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