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EC number: 701-338-8 | CAS number: -
- 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
The LD50's for n-ODSA EC 701-338-8 for acute oral and dermal toxicity testing are greater than 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- guideline study under GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- up-and-down procedure
- Limit test:
- yes
- Specific details on test material used for the study:
- As a result of increasingly rigorous criteria being applied to the analysis of commercial material used in physical property/toxicity testing, the identity of the material has been modified to reveal a more accurate and precise depiction of the commercial substance. This enhancement is reflected in changes in chemical identifiers such as EC and/or CAS numbers from those noted in earlier versions of data records or in study reports.
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories, Inc.
- Age at study initiation: 8-12 weeks
- Weight at study initiation:
- Fasting period before study: no
- Housing: nimals will be housed singly in suspended stainless steel perforated bottom cages or plastic solid bottom cages. Litter paper placed beneath the cage will be changed at least three times/week or Corncob bedding (1/4 inch bed-o'-cobs®, or equivalent) will be changed at least once per week.
- Diet (e.g. ad libitum): Harlan Teklad Global 16% Protein Rodent Diet® #2016, ad libitum.
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 +/- 3C
- Humidity (%): 30-70%,
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To: - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- Several trials were undertaken to solubilize this waxy solid test material in a suitable vehicle for oral gavage administration to rats. Care needed to be taken to avoid aqueous solvents, as the material hydrolyses in water. The substance was gently warmed to 80 degrees C and solubilized in corn oil, which, when cool, was administered to the animals.
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- Limit Test at 2000 mg/kg: If the initial animal survives following dosing, the test substance will be administered sequentially to four additional females so that a total of five animals are dosed; however, if at any time three animals die, the limit test will be terminated and the main test will be conducted. If an animal dies late in the observation period, all dosing should be stopped and the animals already on test should be observed for a similar period prior to proceeding. The LD50 of the test substance will be considered greater than the limit dose if three or more animals out of five survive.
- Statistics:
- Dose progression and stopping criteria will be calculated using a dedicated software program (Acute Oral Toxicity (Guideline 425) Statistical Program) provided by the U.S. Environmental Protection Agency (EPA).
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No deaths; LD0 > 2000 mg/kg bw.
- Mortality:
- No deaths occurred at 2000 mg/kg bw. The LD50 is greater than 2000 mg/kg bw.
- Clinical signs:
- other: No signs of toxicity
- Gross pathology:
- No findings on gross pathology
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information: The LD50 is greater than 2000 mg/kg bw, and so is not classified according to Regulation EC No. 1272/2008.
- Conclusions:
- n-ODSA was tested in an OECD 425 Up-and-down protocol according to GLP, and the LD50 was found to be greater than 2000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- adequate
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
Reference
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:
- October 2013-November 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- guideline study under GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- no
- Specific details on test material used for the study:
- As a result of increasingly rigorous criteria being applied to the analysis of commercial material used in physical property/toxicity testing, the identity of the material has been modified to reveal a more accurate and precise depiction of the commercial substance. This enhancement is reflected in changes in chemical identifiers such as EC and/or CAS numbers from those noted in earlier versions of data records or in study reports.
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Number of Animals: 10
Sex: 5 females and 5 males. Females tested were nulliparous and nonpregnant.
Age/Body weight: Young adult (8-9 weeks)/males 269-280 grams and females 178-196 grams at experimental start.
Source: Received from SAGE Labs on Octoer 21, 2015.
Housing: The animals were singly housed in suspended stainless steel caging, and conformed to size recommendations in the most recent Guide for the Care and Use of Laboratory Animals (Natl. Res. Council, 2011).
An enrichment toy was placed into each cage. Little paper was placed beneath the cage and was changed at least three times per week.
Animal Room Temperature and Relative Humidity Ranges: 19-23 degrees C and 40-61%, respectively.
Animal Room Air Changes/Hour: 12 or 13. Airflow measurements are evaluated regularly and the records are kept on file at Product Safety Labs.
Photoperiod: 12-hour light/dark cycle
Acclimation Period: 8 days
Food: Envigo Teklad Global 16% Protein Rodent Diet #2016. The diet was available ad libitum.
Water: Filtered tap water was supplied ad libitum.
Contaminants: There were no known contaminants reasonably expected to be found in the water or food at levels which would have interfered with the results of this study. Analyses of the food and water are conducted regularly and the records are kept on file at Product Safety Labs.
Cage: Each cage was identified with a cage card indicating at least the study number and identification and sex of the animal.
Animal: A number was allocated to each rat on receipt and a stainless steel ear tag bearing this number to the animal. This number, together with a sequential animal number assigned to study 41876, constituted unique identification. - Type of coverage:
- occlusive
- Vehicle:
- other: 75% w/w mixture in mineral oil
- Details on dermal exposure:
- On the day prior to application, a group of animals was prepared by clipping the dorsal area and the trunk. After clipping and prior to application, the animals were examined for health, weighed (initial), and the skin checked for any abnormalities.
The test substance, as received, was a solid In order to ensure adequate contact with the skin, the test substance was applied as a dry paste (75% w/w mixture in mineral oil).
2000 mg/kg bw of test material was applied to a 2-inch x 3-inch, 4-ply gauze pad and placed on a dose area of approximately 2 inches x 3 inches (approximately 10% of the body surface). The gauze pad and entire trunk of each animal were then wrapped with 3-inch Duropore tape to avoid dislocation of the pad and to minimize loss of the test substance. The rats were then returned to their designated cages. The day of application was considered day 0 of the study. - Duration of exposure:
- Each test animal was exposed for 24 hours. After the 24 hours of exposure to the test substance, the pads were removed and the test sites were gently cleansed with a 3% soap solution followed by tap water and a clean paper towel to remove any residual test substance.
- Doses:
- All test animals received a similar dose of 2000 mg/kg bw. It was applied to a 2-inch x 3-inch area of the body.
- No. of animals per sex per dose:
- 5 female rats and 5 male rats were used in the study. All animals received a similar dose of 2000 mg/kg of the test substance.
- Control animals:
- no
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No deaths
- Mortality:
- The test substance caused no mortality in any of the animals tested.
- Clinical signs:
- other: There were no adverse clinical findings recorded for any animal over the course of the study.
- Gross pathology:
- No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14-day study.
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of an OECD 402 guideline study, the single dose acute dermal LD50 of n-ODSA is greater than 2000 mg/kg bw in male and female rats.
Reference
Animal No. |
Sex |
Body Weight (g) |
Dose |
||
Initial |
Day 7 |
Day 14 |
g |
||
3201 |
M |
269 |
310 |
345 |
0.72 |
3202 |
M |
275 |
322 |
360 |
0.73 |
3203 |
M |
280 |
356 |
399 |
0.75 |
3204 |
M |
279 |
340 |
375 |
0.74 |
3205 |
M |
280 |
317 |
348 |
0.75 |
3206 |
F |
196 |
209 |
223 |
0.52 |
3207 |
F |
187 |
199 |
224 |
0.50 |
3208 |
F |
179 |
195 |
217 |
0.48 |
3209 |
F |
190 |
202 |
234 |
0.51 |
3210 |
F |
178 |
194 |
210 |
0.48 |
Animal Number |
Findings |
Day of Occurance |
Males |
|
|
3201 |
Active and Healthy Erythema at dose site |
0(1-4.5 hrs), 7-14 1-6 |
3202 |
Active and Healthy Erythema at dose site |
0(1-4.5 hrs), 2-14 1 |
3203 |
Active and healthy Erythema at dose site Desquamation at dose site |
0(1-4.5 hrs), 11-14 1-6 5-10 |
3204 |
Active and healthy Erythema at dose site Desquamation at dose site |
0(1-4.5 hrs), 9-14 1 2-8 |
3205 |
Active and healthy Erythema at dose site Desquamation at dose site |
0(1-4.5 hrs), 3-14 1 2-8 |
Females |
|
|
3206 |
Active and healthy Erythema at dose site Desquamation at dose site |
0(1-4.5 hrs), 11-14 1 2-10 |
3207 |
Active and healthy Erythema at dose site Desquamation at dose site |
0(1-4.5 hrs), 11-14 1-2 3-10 |
3208 |
Active and healthy Erythema at dose site Desquamation at dose site |
0(1-4.5 hrs), 9-14 1-6 3-8 |
3209 |
Active and healthy Erythema at dose site Desquamation at dose site |
0(1-4.5 hrs), 10-14 1-6 3-9 |
3210 |
Active and healthy Erythema at dose site Desquamation at dose site |
0(1-4.5 hrs), 12-14 1-2 3-11 |
Animal Number |
Tissue |
Findings |
Males |
|
|
3201-3205 |
All tissues and organs |
No gross abnormalities |
Females |
|
|
3206-3210 |
All tissues and organs |
No gross abnormalities |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- adequate
Additional information
In guideline GLP in vivo studies on acute toxicity of n-ODSA EC 701-338-8 by the oral and dermal routes of administration, no deaths or toxicity were observed. The LD50 values are greater than 2000 mg/kg bw.
Justification for selection of acute toxicity – oral endpoint
experimental data on registered substance
Justification for selection of acute toxicity – dermal endpoint
experimental result on the registered substance
Justification for classification or non-classification
As the oral and dermal LD50 values of n-ODSA EC 701-338-8 exceed 2000 mg/kg bw, the substance is not classified for acute toxicity, according to Regulation EC No. 1272/2008.
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.
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