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EC number: 271-968-1 | CAS number: 68647-71-2
- 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:
- 9 August 2005 to 25 August 2005
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to GLP in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Crude Tall oil
- Molecular formula:
- Not applicab;le as it is a UVCB.
- IUPAC Name:
- Crude Tall oil
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Strain: CRL: CD (SD) BR SPF.
- Age at study initiation: Approximately 8 weeks (males) and 12 weeks (females) at the time of administration.
- Weight at study initiation: 270 to 284 g (males); 245 to 252 g (females).
- Fasting period before study: No.
- Housing: Single caging (39 cm x 23 cm x 18 cm cages) with wire mesh lids. Cages were sanitised once a week. Autoclaved aspen wood chips were used as bedding material; also changed weekly.
- Diet (e.g. ad libitum): gamma irradiated with 25 kGyCo, ad libitum.
- Water (e.g. ad libitum): Tap water, from an automatic watering system, ad libitum.
- Acclimation period: At least 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Average of 22 °C (continuous control and recording).
- Humidity (%): Average of 67 %(continuous control and recording).
- Air changes (per hr): 12 per hour.
- Photoperiod (hrs dark / hrs light): Artificial light from 6 am to 6 pm.
IN-LIFE DATES: From: 9 August 2005 To: 25 August 2005
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: A single dermal administration was performed by spreading the test material on an area of 6.5 x 8 cm (52 cm2). The test site was located on the dorsal thoracal region. The hair of the dorsal trunk was clipped with an electrical hair clipper (Aesculap GH, 0.1 mm cutter head) one day prior to application.
- % coverage: At least 10 % of the estimated body surface.
- Type of wrap if used: A cellulose patch (Pehazell, Hartmann AG) with the calculated amount of the test material on the surface was applied to the test site and held in place by fixing marginally with non irritating tape (Blenderm Wundpflaster, 3M). Patch and tape were covered semi-occlusively by a dressing (Fixomull Stretch, Fa. Beiersdorf).
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test substance was wiped off using wet cellulose tissue, if necessary, once the dressing, the tape and the patch were removed at the end of the eposure period.
- Time after start of exposure: At the end of the exposure period (24 hours).
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bodyweight; the amounts were calculated and weighed for each individual using the body weights determined on the day of the administration. - Duration of exposure:
- 24 hours.
- Doses:
- 2000 mg/kg bodyweight.
- No. of animals per sex per dose:
- 5 animals per sex per dose.
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: Observations were performed at 0 to 0.5, > 0.5 to 1, > 1 to 2, > 2 to 4 and > 4 to 6 hours after administration and then at least once a day. Observations included but were not limited to changes in skin, fur, eyes, the occurrence of secretions and excretions, autonomic activity, changes in gait, posture and the presence of convulsions. No skin examination of the administration site was possible during the exposure period, while it was covered by the patch and wrappings.
Body weights were determined before administration, 7 and 14 days after dosing. Body weight gain was calculated for each week of the study, between 0 and 7 days and 7 and 14 days after dosing.
- Necropsy of survivors performed: Yes. All animals were killed by inhalation of 80 % CO2 + 20 % O2 14 days after dosing and subjected to a necropsy including a gross pathological examination.
- Justification for selection of the dose level: In a range finding study, three groups of one male and one female each were dosed with 400, 894 or 2000 mg/kg bodyweight. All animals survived for 7 days; therefore a limit-test with one dose of 2000 mg/kg body weight was performed. Both animals, dosed with 2000 mg/kg in the preliminary test were included into the main study.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There was no mortality. All animals survived until the scheduled termination of the study.
- Clinical signs:
- other: All animals were normal during the entire observation period. Exposed skin was not found to be altered by the test material.
- Gross pathology:
- All animals were normal at terminal necropsy.
- Other findings:
- No noteworthy sex difference in the response to the test material was derived from clinical observations or post-mortem findings.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study, the acute dermal LD50 of the substance in rats was determined to be >2000 mg/kg bw.
- Executive summary:
The acute dermal toxicity potential of the test substance was determined according to OECD Guideline 402 and EU Method B.3 under GLP conditions. The test substance was administered once dermally on the dorsal thoracal region of 5 male and 5 female Sprague Dawley rats at a limit dose of 2000 mg/kg bw. A cellulose patch with the individually weighed amount of the test substance on the surface was applied to the test site and held in place by fixing marginally with non irritating tape. This was covered by a semi-occlusive dressing and left in place for 24 hours. There was no mortality and no local or systemic effects related to administration of the test material. All animals appeared normal at necropsy. Under the conditions of this study the acute dermal LD50 of the substance in rats was determined to be >2000 mg/kg bw (Bernat, 2005).
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