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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
Acute Toxicity: dermal
Administrative data
- 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.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- 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
Test material
- Reference substance name:
- Fatty acids, tall-oil, reaction products with boric acid (H3BO3) and diethanolamine
- EC Number:
- 294-785-9
- EC Name:
- Fatty acids, tall-oil, reaction products with boric acid (H3BO3) and diethanolamine
- Cas Number:
- 91770-03-5
- IUPAC Name:
- Fatty acids, tall-oil, reaction products with boric acid (H3BO3) and diethanolamine
Constituent 1
Test animals
- 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
Administration / exposure
- 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
Results and discussion
- Preliminary study:
- Not applicable
Effect levels
- 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.
Any other information on results incl. tables
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 |
Applicant's summary and conclusion
- 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.
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