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EC number: 294-785-9 | CAS number: 91770-03-5
- 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
Acute oral toxicity: The LD50 (rat) was > 5000 mg/kg bw (equivalent or similar to 16 CFR 1500.3).
Acute inhalation toxicity: No data are available for the inhalation route. The substance is a liquid with a vapour pressure of 3.5 x 10E-04 Pa at 25 °C and is used primarily as a component of lubricants by workers and consumers. It is expected that inhalation exposure from these uses will be low and that the most likely route of exposure for workers and consumers is the dermal route.
Acute dermal toxicity: The
LD50 (rabbit) was > 2000 mg/kg bw (equivalent or similar to 16 CFR
1500.4).
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:
- 10 September 1982 - 20 October 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- GLP-like (QA signature) with limited information on individual animals
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: 16 CFR 1500.3 Federal Hazardous Substances Act Regulations.
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- GLP-like (QA signature)
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: No data available.
- Age at study initiation: No data available.
- Weight at study initiation: average weight between 200~300 g.
- Fasting period before study: Feed (not water) was withheld overnight prior to dosing.
- Housing: The animals were housed and maintained in accordance with the Animal Welfare Act 9 CFR Part Stainless steel with elevated wire mesh flooring; 3 - 5 rats/cage by sex
- Water: Tap water ad libitum
- Acclimation period: acclimated to the laboratory for an appropriate time prior to dosing.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 70 ± 2°F (22°C)
- Humidity (%): 45 ± 5%
- Air changes: controlled environment, but no air change information provided.
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
IN-LIFE DATES: From: 1982-09- 10 To: 1982 -09-24 - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: Not applicable
- Amount of vehicle (if gavage): Not applicable
- Justification for choice of vehicle: Not applicable
- Lot/batch no. (if required): Not applicable
- Purity: Not applicable
MAXIMUM DOSE VOLUME APPLIED: No data. Volume seleted to deliver dose of 5000 mg/kg bw
DOSAGE PREPARATION (if unusual): Not applicable
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Not applicable - Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5 animals/sex/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed frequently on the day of dosage and twice daily thereafter (morning and afternoon). Individual weights were recorded on the day of dosage, weekly thereafter and prior to sacrifice.
- Necropsy of survivors performed: gross necropsies were performed on all animals that either died during the 14 day observation period or on surviving animals that were sacrificed at the conclusion of the 14 day observation period. - Statistics:
- No data available
- Preliminary study:
- Not applicable
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortalities
- Clinical signs:
- other: The animals had ruffled fur after 3 hours. They appeared normal within 24 hours and throughout the remainder of the observation period.
- Gross pathology:
- No gross abnormalities were noted in all animals.
- Interpretation of results:
- not classified
- Conclusions:
- The test article, when administered as received to male/female Sprague-Dawley rats, had an acute oral LD50 of greater than 5000 mg/kg bodyweight
- Executive summary:
Test Guidance
Acute oral toxicity was investigated using a similar method to that given in 16 CFR 1500.3 of the Federal Hazardous Substances Act Regulations.
Method and Material
A group of ten (5 male and 5 female) albino rats (Sprague-Dawley) were dosed with 5000 mg/kg of the test material by oral gavage. The animals were observed for 14 days after test material administration for signs of toxicity and mortalities. Gross autopsies were performed on all animals that either died within the 14 day observation period or on surviving animals.
Results
There were no mortalities or signs of clinical toxicity.
Conclusion
The acute oral LD50 in male and female rats was determined to be > 5000 mg/kg bw.
Reference
Table 1. Results
Dose Level (mg/kg) |
5000 |
||
Sex |
Male |
Female |
|
Average Body Weight (g) |
Initial |
243 |
218 |
7 d |
298 |
248 |
|
14 d |
344 |
243 |
|
Mortality (No. death/No. dosed) |
0/5 |
0/5 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
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:
- 26 January 1984 - 21 February 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- GLP-like (QA signature) with limited details on individual animals
- Justification for type of information:
- Study performed prior to commencement of REACH.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: US 16 CFR 1500.4 Federal Hazardous Substances Act
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- GLP-like (QA signature)
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: No data available
- Weight at study initiation: 2.3-3.0 kg
- Fasting period before study:
- Housing: The animals were individually housed and maintained in accordance with standards set forth in the Guide for the Care and Use of Laboratory Animals (DHEW publication No. 80-23)
- Water: tap water was available ad libitum
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 60-75
- Humidity (%): 40-45
- Air changes (per hr): controlled environment, but no air change information provided
- Photoperiod: 12 h light/dark cycle
IN-LIFE DATES: From: To: 1/26/84-2/9/84 - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: back, abraided and intact skin
- % coverage: approximately 10 % of total body surface area.
- Type of wrap if used: gauze patch covered with an impervious material.
REMOVAL OF TEST SUBSTANCE
- Washing: excess material was removed by wiping but not washing.
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied: correct amount to give a dose of 2000 mg/kg bw (not specified in the report)
- Concentration (if solution): the test material was used undiluted as supplied
- Constant volume or concentration used: yes
- For solids, paste formed: Not applicable
VEHICLE
- Amount(s) applied: Not applicable
- Concentration (if solution): Not applicable
- Lot/batch no.: Not applicable
- Purity: Not applicable - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 animals/sex/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed daily for deaths or overt signs of toxicity. Individual bodyweights were recorded prior to application of the test material and Day 0 and on Days 7 and 14.
- Necropsy of survivors performed: gross necropsies were performed on all animals after sacrifice at the conclusion of the 14 day observation period. - Statistics:
- No data available
- Preliminary study:
- Not applicable
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Male: Number of animals: 5; Number of deaths: 0
Female: Number of animals: 5; Number of deaths: 0 - Clinical signs:
- other: There were no signs of systemic toxicity.
- Gross pathology:
- Male: No gross abnormalities were noted
Female: no formed fecal material and spongy kidneys were noted for the animal that exhibited a loss in bodyweight. No gross abnormalities were noted for the remaining four animals - Other findings:
- - Other observations: dermal reactions
Male/female: mild to moderate erythema was observed after unwrapping at 24 hours. By 4 days all animals exhibited eschar which persisted through day 14 of the study. - Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test article, when administered as received to male and female New Zealand White rabbits, had an acute dermal LD50 of greater than 2000 mg/kg bodyweight
- Executive summary:
Test Guidance
Acute dermal toxicity was performed to a method described in US 16 CFR 1500.4 Federal Hazardous Substances Act
Method and Material
A single dose of 2 g/kg undiluted test material was applied to the shaved backs of ten New Zealand White rabbits (5 males and 5 females). The skin of five animals (2 males and 3 females) was abraded prior to dosing. The test material was covered with an occlusive dressing for a period of 24 hours. At the end of the exposure period, the treated area was wiped to remove any residual test material. The animals were observed for deaths or overt signs of toxicity daily for 14 days. The sites were also examined for evidence of primary irritation daily for 14 days. Individual bodyweights were recorded prior to application of the test material at the start of the study and on days 7 and 14. At the end of the observation period all animals were euthanized and subjected to gross necropsy.
Results
There were no deaths or clinical signs of toxicity during the study. A loss of bodyweight was noted for one female at 14 days, all other animals showed expected gains. Mild to moderate erythema was observed in all animals after the 24 hour exposure and by day 4 of the observation period all animals exhibited eschar which persisted through day 14 of the study. Gross pathological examination showed no formed fecal material and spongy kidneys in the female that lost weight. No abnormalities were noted in the other animals. .
Conclusion
The dermal LD50 of the test material in male and female rabbits has been determined to be greater than 2000 mg/kg bw.
Reference
Table 1: Summary of mortality and bodyweight data
|
Males |
Females |
||
Intact |
Abraded |
Abraded |
Intact |
|
Mortality after 14 days |
0 |
0 |
0 |
0 |
Average bodyweights (kg) |
||||
Initial |
2.87 |
2.73 |
2.70 |
2.73 |
7thday |
2.89 |
2.82 |
2.82 |
2.66 |
Final |
2.92 |
3.01 |
2.86 |
3.05 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
Acute oral toxicity:
Acute oral toxicity was investigated using a similar method to that given in 16 CFR 1500.3 of the Federal Hazardous Substances Act Regulations [Costello, 1982]. A group of ten (5 male and 5 female) albino rats (Sprague-Dawley) were dosed with 5000 mg/kg of the test material by oral gavage. The animals were observed for 14 days after test material administration for signs of toxicity and mortalities. Gross autopsies were performed on all animals that either died within the 14 day observation period or on surviving animals. There were no mortalities or signs of clinical toxicity. The acute oral LD50 in male and female rats is > 5000 mg/kg bw.
Acute inhalation toxicity:
No data are available for the inhalation route. The substance is a liquid with a vapour pressure of 3.5 x10E-04 Pa at 25°C and is used primarily as a component of lubricants by workers and consumers. It is expected that inhalation exposure from these uses will be low and that the most likely route of exposure for workers and consumers is the dermal route.
Acute dermal toxicity:
Dermal toxicity was investigated using a similar method to that given in 16 CFR 1500.4 of the Federal Hazardous Substances Act Regulations. A single dose of 2 g/kg undiluted test material was applied to the shaved backs of ten New Zealand White rabbits (5 males and 5 females). The skin of five animals (2 males and 3 females) was abraded prior to dosing. The test material was covered with an occlusive dressing for a period of 24 hours. At the end of the exposure period, the treated area was wiped to remove any residual test material. The animals were observed for deaths or overt signs of toxicity daily for 14 days. The sites were also examined for evidence of primary irritation daily for 14 days. Individual bodyweights were recorded prior to application of the test material at the start of the study and on days 7 and 14. At the end of the observation period all animals were euthanized and subjected to gross necropsy. There were no deaths or clinical signs of toxicity during the study. A loss of bodyweight was noted for one female at 14 days, all other animals showed expected gains. Mild to moderate erythema was observed in all animals after the 24 hour exposure and by day 4 of the observation period all animals exhibited eschar which persisted through day 14 of the study. Gross pathological examination showed no formed fecal material and spongy kidneys in the female that lost weight. No abnormalities were noted in the other animals. The dermal LD50 of the test material in male and female rabbits was determined to be > 2000 mg/kg bw.
Justification for classification or non-classification
No adverse effect was observed during investigation of acute toxicity via the oral or dermal routes in female rats and, based on determined vapour pressure of the substance, exposure via the inhalation route is not considered to be of significance to humans under general use conditions at ambient temperature. As such, classification in accordance with Regulation (EC) No 1272/2008 is not required.
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