Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012-02-29 to 2012-04-04
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
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
- Details on test material:
- - Substance type: 100% UVCB
- Physical state: Dark coloured liquid
- Expiration date of the lot/batch: February 2, 2013
- Stability under test conditions: stable for duration of testing
- Other: Solubility in various solvents unknown
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 11 weeks
- Weight at study initiation: 19.2 - 25.4 g
- Housing: Plastic solid bottomed cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 8-21 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 26°C
- Humidity (%): 45-53%
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
IN-LIFE DATES: From: 2012-02-29 To: 2012-040-04
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- Preliminary test: 80, 50, 25, 20, 10 and 5%
Main test: 10, 5 and 1% - No. of animals per dose:
- 5/dose level
- Details on study design:
- RANGE FINDING TESTS:
- Irritation: Scored for erythema pre-dose Days 1, 2, 3 and on Day 6. Ear-swelling measurements (duplicate) of each animal on Day 1 (pre-dose), Day 3 (ca. 48 hours after 1st dose) and Day 6 prior to scarifice.
- Lymph node proliferation response: Not measured
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Random assignment
- Criteria used to consider a positive response: Erythema and Oedema to modified Draize scoring method. Ear- swelling based on percentage change from control. Sensitisation respnse by B-scintillation (disintegrations per minute, dpm); mean dpm per test group /mean dpm of vehicle control group. SI > 3 = positive response.
TREATMENT PREPARATION AND ADMINISTRATION:
Dilutions of the test substance were prepared as w/w mixtures in acetone/olive oil (AOO 4:1 v/v). A single concentration of the positive control (25%w/w mixture of HCA in AOO) was prepared. All dosage preparations were freshly prepared on the day of administration.
Beginning on Day 1, 25µL of the appropriate test substance concentration, vehicle alone or the positive control substance was applied tothe dorsum of bpth ears of each mouse once per day for three consecutive days using a micropipette. During application, the material was spread as evenly as possible over the dorsal surface of the ear using the tip of the pipette.
On Day 6 of the study ( 3 days after the final topical application) 250 µL of sterile phosphate buffered saline containing 20 µCi of 3-H-methyl thymidine was injected intravenously via the tail vein of each mouse.
Approximately 5 hours after the injection, the draining auricular lymph nodes from all animals were excised. The lymph nodes were pooled for each individual mouse. A single cell suspension of lymph node cells (LNC) was prepared in PBS by gently massaging the lymph nodes between the frosted ends of two microscope slides ovaer a collection vessel. The slides were then briefly rinsed with PBS into the vessel. The vessel contents were centrifuged for approximately 10 minues at 1800 rpm twice and washed. After the second wash ca. 5 mL of 5% trichloracetic acid (TCA) in distilled water was added to the sediment and vortexed. The DNA was precipitated in the 5% TCA at 4.0 - 5.2°C overnight (ca. 18 hours).
After precipitation the tubes were centrifuged and the suprnatent discarded. The resulting precipitate was resuspended in 1 mL of 5% TCA and transferred to 10 mL scintillation fluid. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Significance judged at p<0.05. Treated groups and negative vehicle control group were compared using a One-Way Analysis of Variance (ANOVA), followed by comparison of the treated groups to control by Dunnett's t-test for multiple comparisons. Where variances are considered significantly different by Bartlett's test groups were compared using a non-parametric method (Kruskal-Wallis non parametric analysis of variance followed by Dunn's test). Outlier analysis was conducted using Grubbs (1969).
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 0.95
- Variability:
- Group Mean DPM 1408.36
- Test group / Remarks:
- 1% Test substance
- Parameter:
- SI
- Value:
- 2.07
- Variability:
- Group Mean DPM 13077.36
- Test group / Remarks:
- 5 % Test Substance
- Parameter:
- SI
- Value:
- 3.96
- Variability:
- Group Mean DPM 5890.90
- Test group / Remarks:
- 10 % Test Substance
Any other information on results incl. tables
Although nine mice lost or failed to gain body weight during the study, all animals appeared active and healthy throughout the study.
Group 1; Vehicle control: Very slight erythema noted at two test sites between Days 2 and/or 3
Group 2; Positive control: Very slight erythema noted at most sites between Days 2 and/or 6
Group 3; 1% test conc.: Very slight erythema noted at three sites between Days 2 and/or 6
Group 4; 5% test conc.: Very slight erythema noted at most sites between Days 2 and/or 6
Group 5; 10% test conc.: Very slight to well-defined erythema noted at all sites between Days 2 and/or 6
See Table 4 in attached document: LLNA_Durando 2012_Results Tables Treatment of mice with 1, 5 or 10% of the test material resulted in stimulation index values of 0.95, 2.07 and 3.96, respectively, relative to vehicle control mice. The substance was considered positive for a dermal sensitisation potential with a score > 3 at a test concentration at 10%. The positive control elicited a response of 4.66 relative to the vehicle control. The EC3 value was calculated to be 7%.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Conclusions:
- The test substance is considered to be a contact dermal sensitiser at concentrations of greater than or equal to 7% (EC3 value)
- Executive summary:
Test Guidance
OECD 429, EU Method B.42 and US EPA OPPTS 870.2600
Method and material
Three concentrations of the test substance in acetone/olive oil (AOO 4:1 v/v) or the vehicle alone were topically applied to twenty healthy mice (5/dose) for three consecutive days. Three days after the last application, the mice were given a 20 µCi IV injection of 3H-methyl thymidine. Five hours later, the draining (auricular) lymph nodes were harvested and prepared for analysis in a scintillation counter. The results were presented as disintegrations per minutes per mouse (dpm/mouse). The ears of each animal were also evaluated for erythema and oedema prior to each application and again on Day 6, prior to the IV injection. A positive control group (5 animals) was maintained under the same environmental conditions and treated with 25% w/w mixture of alpha-hexylcinnamaldehyde (HCA) in AOO in the same manner as the test animals. Ear thickness (swelling) was taken on the preliminary, test and control animals on Day 1 (predose), Day 3 (ca 48 hours aftre the first dose), and Day 6 prior to sacrifice.
Results
Treatment of mice with 1, 5 or 10% of the test material resulted in stimulation index values of 0.95, 2.07 and 3.96, respectively, relative to vehicle control mice. The substance was considered positive for a dermal sensitisation potential with a score > 3 at a test concentration at 10%. The positive control elicited a response of 4.66 relative to the vehicle control. The EC3 value was calculated to be 7%.
Conclusions
The test substance is considered to be a contact dermal sensitiser at concentrations of greater than or equal to 7 % (EC3 value).
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.