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EC number: 939-718-2 | CAS number: 1474044-80-8
- 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
The oral LD50 is 1,750 mg/kg.
The dermal LD50 ~ 10,000 mg/kg.
The use as a lubricant additive is unlikely to result in significant
human exposure to inhalable droplets. In addition, a 1 hour exposure at
21 mg/L did not cause toxic symptoms or death.
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:
- 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted prior to GLP regulations but used methods generally consistent with accepted procedures. More animals were used than required by current protocols and a good dose-response and statistically valid LD50 value were obtained.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- not specified
- GLP compliance:
- no
- Test type:
- fixed dose procedure
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- Rats derived from Royalhart Colony.
Rats were fasted 18 hours before dosing and then individually and singly dosed by gavage. - Doses:
- 2,3,4,5, and 6 ml/kg bw
- No. of animals per sex per dose:
- 5 males
5 females - Control animals:
- no
- Details on study design:
- Five groups of 5 male and 5 female rats, weighing 200-300 grams, were used in each of 5 treatment groups.
- Statistics:
- LD50 calculated by Litchfield-Wilcoxin Method of Probit Analysis
- Preliminary study:
- A separate study (T-399) was conducted earlier (July 10, 1978) with a single dose of 5 dose of 5 grams / kg bw.
10 male rats (207 - 294 grams) were used. 7 of 10 (70%) of the treated rats died. - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 3.5 mL/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 2.8 - <= 4.3
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 1 750 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
see attached table
Oral LD50 : 3.5 ml/kg 95% confidence limits 2.8-4.3 ml/kg- Clinical signs:
- other: Not reported
- Gross pathology:
- see attached table
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- Oral LD50 = 3.5 ml/kg bw (as tested formulation)
Oral LD50 = 1750 mg/kg bw (based on 50% purity) - Executive summary:
Five male and 5 female rats were dosed with the test substance at 2, 3, 4, 5, and 6 ml/kg bw.
The calculated oral LD50 is 3.5 ml/kg bw.
The oral LD50 is 1750 mg/kg bw (based on 50% purity of formulation).
The following mortality was observed:
Group
Dose
ml/kg-bw
Male
Female
% Mortality
1
2
0/5
2/5
20
2
3
1/5
2/5
30
3
4
3/5
3/5
60
4
5
2/5
4/5
60
5
6
5/5
4/5
90
Reference
Group |
Dose ml/kg-bw |
Male |
Female |
% Mortality |
1 |
2 |
0/5 |
2/5 |
20 |
2 |
3 |
1/5 |
2/5 |
30 |
3 |
4 |
3/5 |
3/5 |
60 |
4 |
5 |
2/5 |
4/5 |
60 |
5 |
6 |
5/5 |
4/5 |
90 |
Clinical Observation |
2 mg/kg No. Animals |
3 mg/kg No. Animals |
4 mg/kg No. Animals |
5 mg/kg No. Animals |
6 mg/kg No. Animals |
Discolored Spleen |
1 |
1 |
1 |
2 |
5 |
Discolored Liver |
1 |
|
3 |
3 |
8 |
GI Tract Hemorrhage |
|
1 |
|
|
|
Ocular Hemorrhage |
|
|
1 |
3 |
1 |
Subcutaneous Hemorrhage |
1 |
|
|
1 |
|
Lung Hemorrhage |
1 |
2 |
5 |
5 |
7 |
No. Animals Examined |
10 |
10 |
10 |
10 |
10 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 1 750 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 10 000 mg/kg bw
- Quality of whole database:
- Two dermal studies were available in rabbits. Study dermal.001 (1981) used a dose of 1000 mg/kg and produced no mortality. Study dermal.002 (1978) used a dose of 10,000 mg/Kg in which 5/10 rabbits died. Together they show the NOEL was greater than 1000 mg/kg and that the LD50 is ~ 10,000 mg/kg on active ingredient basis. The 2 studies have consistent resutls and together form a quality database.
Additional information
Justification for selection of acute toxicity – oral endpoint
Study was conducted prior to GLP regulations but used methods
generally consistent with accepted procedures. More animals were used
than required by current protocols and a good dose-response and
statistically valid LD50 value were obtained. The LD50 of 1750 is based
on active ingredient composition of the formulation tested.
Justification for selection of acute toxicity – inhalation endpoint
The use as a lubricant additive is unlikely to result in significant
human exposure to inhalable droplets.
An inhalation study is available that was conducted with a 1 hour
exposure (4 hour exposure is required). This study showed no toxicity at
an exposure of 21 mg/Liter (Acute Inhalation Study, Report T-378, June
1, 1978).
Justification for selection of acute toxicity – dermal endpoint
The study was not conducted to meet GLP regulations, however, the
test followed standard guideline procedures (US Federal Hazardous
Substances
Labeling Act (FHSLA) 16 CFR 1500). More animals were tested (10) than
are used in current tests so the test result is statistically valid.
Rabbit skin in this test was abraded in 5 rabbits which increases dermal
penetration and increases exposure relative to current testing methods.
Justification for classification or non-classification
Based on data the substance is classifiable for acute oral toxicity Category 4 according to CLP. Annex VI CLP requires barium salts in general, not covered by an exemption, to be classified also for inhalative acute toxicity, Category 4. Despite the available data, that clearly indicate no need for classification, the classification harmful by the inhalation route is included in the proposal for C&L for this substance. No classification for acute dermal toxicity is required. Also, no classification for aspiration hazards is required, as the substance is not a hydrocarbon. Classification for STOT SE is also not required, as no such effects were seen in any of the studies. In conclusion the substance is classifiable for acute toxicity by oral and inhalation route Category 4 according to CLP (Regulation EC No 1272/2008).
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