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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: oral
Administrative data
- 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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- 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
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:
- 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
Administration / exposure
- 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
Results and discussion
- Preliminary study:
- Not applicable
Effect levels
- 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.
Any other information on results incl. tables
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 |
Applicant's summary and conclusion
- 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.
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