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EC number: 268-453-9 | CAS number: 68092-29-5
- 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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14 November 2016 - 21 November 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Tall oil, compd. with triethanolamine
- EC Number:
- 268-453-9
- EC Name:
- Tall oil, compd. with triethanolamine
- Cas Number:
- 68092-29-5
- Molecular formula:
- Various
- IUPAC Name:
- Tall oil, compd. with triethanolamine
- Test material form:
- liquid: viscous
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Afton Chemical Corporation.
- Lot/batch No. of test material: LAB 4483
- Expiration date of the lot/batch: Manufacture date on CoA is 26 October 2017. Shelf life at ambient temperature is 12 months. Expiry date is not stated in the report. Using the manufacturing date and shelf life, the expiry date is 26th October 2018.
- Purity test date: Not stated
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Ambient temperature
- Stability under test conditions: Stable under the conditions of the test protocol, (private communication sponsor)
- Solubility and stability of the test substance in the solvent/vehicle: Test substance used as received
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Test substance used as received (unchanged)
OTHER SPECIFICS: none
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- Female, nulliparous and non-pregnant
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kuiper Rabbitry, Gary, Indiana, USA
- Age at study initiation: Approximately ten to twelve weeks old
- Weight at study initiation: 2.70 to 3.01 kilograms
- Housing: Individually housed in stainless steel cages
- Diet: Purina Laboratory Rabbit Chow ad libitum
- Water: Ad libitum
- Acclimation period: At least five days prior to study initiation
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3° C
- Humidity (%): 30 - 70%
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): 12 hour light / 12 hours dark cycle
IN-LIFE DATES: From: 14 November 2016 to 21 Novermber 2016
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Remarks:
- using electrical clippers from the midline of the back to the abdomen
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume with unit): 0.5 mL aliquot
- Concentration (if solution): Test substance used as received (unchanged)
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- Dermal irritation readings for erythema and edema were performed at 0.5, 24, 48, 72 and 168 hours after test substance removal. Grading and scoring of irritation were performed in accordance with the Draize scoring system.
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm² (application site was located approximately 5-7 centimeters down from the backbone).
- % coverage: not specified
- Type of wrap if used: The test substance was covered with a 2.5 cm² - 2 layer gauze patch held in place with non-irritating Kendall Curity
Standard Porous Tape and the patch was then covered with a semi-occlusive plastic overwrap secured in place with Kendall Curity Standard Porous Tape for the duration of the exposure period.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, at the end of the 4 hour contact period residual material was removed from the site;
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
(indicate if minutes, hours or days) Dermal irritation readings for erythema and edema were performed at 0.5, 24, 48, 72 and 168 hours after
test substance removal.
SCORING SYSTEM:
- Method of calculation: Grading and scoring of irritation are performed in accordance with the Draize scoring system. The values for erythema and eschar formation are summed and divided by the number of animals scored for each observation period. Values for edema formation are summed and divided by the number of animals scored for each observation period. The average value for erythema/eschar formation and the average value for edema formation are summed to obtain the daily
irritation score.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0.43
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Reversibility:
- fully reversible within: 0.5 hours
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- -
- Other effects:
- - Other adverse local effects:
None specified
- Other adverse systemic effects: None specified
Any other information on results incl. tables
Acute Skin Irritation
OBSERVATION TIME (HOURS)
|
ER = Erythema
ED = Edema
Primary Skin Irritation Scores:
0.5 hours = 1.33
24 hours = 0.67
48 hours = 0.33
72 hours = 0.33
Primary Irritation Index (0.5, 24, 48 and 72 hour scores only) / 4 = 0.67
Applicant's summary and conclusion
- Interpretation of results:
- other:
- Conclusions:
- There were minimal irritation reactions in all of the test subjects which cleared by the 168 hour observation. The maximum skin irritation score was 1.33 at the 0.5 hour observation. The primary skin irritation index was calculated to be 0.67.
In accordance with the OPPTS Guidelines, Tall Oil TEA Salt, LAB 4483 meets the requirements for EPA Toxicity Category IV for dermal effects. According to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2015) (including all amendments), Tall oil TEA salt will not be classified for skin Irritation. According to the Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments), Tall oil TEA salt will not be classified for skin irritation. - Executive summary:
An acute dermal irritation study in male rabbits was performed using Tall Oil TEA Salt in accordance with U.S. EPA Health Effects Test Guidelines, OPPTS 870.2500 and OECD Guidelines for the Testing of Chemicals, Test No. 404. This study is reliable (Klimisch 1, reliable without restriction) with no deviations, and meets current US EPA and OECD guidence requirements.
Tall Oil TEA Salt, LAB 4473 was applied at a dose of 0.5 ml to an unabraded site on a clipped area of each of three albino rabbits. In all three dosed animals the site of application was graded for indication of skin reactions at 0.5, 24, 48, 72 and 168 hours after test substance removal. There were minimal skin irritation reactions in all test subjects which cleared by the 168 hour observation. The maximum skin irritation score was 1.33 at the 0.5 hour observation point. The primary skin irritation index was 0.67.
In accordance with the OPPTS Guidelines, Tall Oil TEA Salt LAB 4483 meets the requirements for EPA Toxicity Category IV for dermal effects. In accordence with the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2015) (including all amendments), and according to the Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments), Tall oil TEA salt does not warrant classiifcation for skin irritation.
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