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EC number: 262-996-5 | CAS number: 61788-67-8
- 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
No concern for acute toxicity regarding oral and dermal exposure routes
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:
- 21 April 2010 - 01 June 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline Study (OECD 420, EC B.1 bis)
- Justification for data waiving:
- other:
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Ltd, Bicester, Oxon, UK
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 173 - 178 g
- Fasting period before study: overnight before dosing, and approximately 3-4 hours after dosing
- Housing: housed in groups of up to four in suspended solid-floor polypropylene cages furnished with woodchips
- Diet (e.g. ad libitum): ad libitium access to 2014 Teklad Global Rodent diet
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25 degrees C
- Humidity (%): 30- 70 percent
- Air changes (per hr): at least 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark
IN-LIFE DATES: Not reported - Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Remarks:
- BP
- Details on oral exposure:
- VEHICLE: no details reported
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg
DOSAGE PREPARATION (if unusual): suspension of test item in distilled water
CLASS METHOD: not applicable
VEHICLE
- other: arachis oil BP was used for the 300 mg/kg dose level, no vehicle was used for the 2000 mg/kg dose level
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg
DOSAGE PREPARATION (if unusual): not applicable
CLASS METHOD: not applicable - Doses:
- 300, 2000 mg/kg
- No. of animals per sex per dose:
- 1 animal at 300 mg/kg, 5 animals at 2000 mg/kg
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observations, weighed at days 0, 7, 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross necropsy (external examination and opening of abdominal and thoracic cavities to look for macroscopic abnormalities) - Statistics:
- None reported
- Preliminary study:
- One animal was treated with 300 mg/kg bw test material suspended in Arachis oil BP and observed for 14 days. The animal exhibited no mortality, no signs of cystemic toxicity, expected gains in bodyweight, no abnormalities at necropsy.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no effects were observed at the highest dose tested, 2000 mg/kg bw
- Mortality:
- No deaths observed
- Clinical signs:
- other: No signs of systemic toxicity were noted
- Gross pathology:
- No abnormalities were noted at necropsy.
- Other findings:
- Not applicable
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information: GHCS system
- Conclusions:
- The acute oral median lethal dose (LD50) of the test material in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bodyweight (Globally Harmonised Classification System - unclassified).
- Executive summary:
Study Summary:
Introduction. The study was performed to assess the acute oral toxicity of the test material in the Wistar strain rat. The method was designed to meet the requirements of the following:
- OECD Guideline for Testing of Chemicals No 420 “Acute oral toxicity – fixed dose method” (adopted 17 December 2001)
- Method B1 bis Acute toxicity (oral) of Commission Regulation (EC) No. 440/2008
Method. Following a sighting test at dose levels of 300 and 2000 mg/kg, a further group of four fasted female animals were given a single oral dose of undilted test material at a dose level of 2000 mg/kg bodyweight. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.
Morality. There were no deaths.
Clinical Observations. There were no signs of systemic toxicity ntoed.
Bodyweight. All animals showed expected gains in bodyweight.
Necropsy. No abnormalities were noted at necropsy.
Conclusion. The acute oral median lethal dose (LD50) of the test material in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bodyweight (Globally Harmonised Classification System – Unclassified).
Reference
Table 5. Individual bodyweights and bodyweight changes.
Dose level, mg/kg |
Animal number and sex |
Bodyweight (g) at Day |
Bodyweight gain (g) during week |
|||
0 |
7 |
14 |
1 |
2 |
||
2000 |
2-0 Female |
169 |
181 |
193 |
12 |
12 |
3-0 Female |
176 |
189 |
199 |
13 |
10 |
|
3-1 Female |
170 |
186 |
199 |
16 |
13 |
|
3-2 Female |
194 |
210 |
230 |
16 |
20 |
|
3-3 Female |
176 |
200 |
216 |
24 |
16 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
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:
- 2010
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Only preliminary results are available at present time.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: HsdRccHan(TM)WIST
- Sex:
- male/female
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Duration of exposure:
- 24 hours
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- other: no information at that time
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- males: 0/5
females: 0/5 - Interpretation of results:
- other: does not trigger criteria for toxicity classification
- Remarks:
- Criteria used for interpretation of results: other: CLP
- Conclusions:
- The dermal median lethal dose was > 2000 mg/kg for acute (24-hour) exposure for rat. This does not classify the substance under the CLP regulation.
- Executive summary:
Not available yet (preliminary results)
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
Acute oral exposure data are available for the sodium salt of sulphated castor oil. No toxicity was observed in a 1984 EC guideline study with rats at a single dose of 15,600 mg/kg bw. Read across from similar substances (sulfited fat liquors EC 307-037-4 fish oil and EC 281-975-1 rape oil) indicate the substances have low acute toxicity. The more conservative 2000 mg/kg bw no effect levels from the more extensive read across studies was used as the starting point to derive DNELs for the sulfated fat liquors.
Justification for selection of acute toxicity – oral endpoint
No data on the substance are available. The result of the testing on acute toxicity performed on the analogous sulphited vegetable oils sodium salt has been considered as read across
Justification for selection of acute toxicity – dermal endpoint
No data on the substance are available. The result of the testing on acute toxicity performed on the analogous sulphited vegetable oils sodium salt has been considered as read across
Justification for classification or non-classification
The substance is not considered dangerous for acute toxicity following CLP criteria set out in the Regulation 1272/2008
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