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EC number: 252-813-7 | CAS number: 35948-25-5
- 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:
- The experimental work was carried out between 13/06/1994 and 30/06/1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Performed according to GLP and OECD Guidelines and no deviations reported
- Justification for data waiving:
- other:
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Ukanol DOP 95 (HCA)
- IUPAC Name:
- Ukanol DOP 95 (HCA)
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Ukanol DOP 95
- Physical state: a white powder
- Other: Test article characterisation, purity, stability etc. is the responsibility of Sponsor.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: SPF Wistar rats of the stock Mol:WIST
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Stock Mol:WIST from the MØIIegaard Breeding Centre Ltd., Ejby, DK-4623 Lille Skensved
- Age at study initiation: At the beginning of the study the male rats were 8 to 9 weeks old and the female rats were 7 to 8 weeks.
- Weight at study initiation: Male rats weighed 138 to 160 g and female rats weighed 134 to 146 g.
- Housing: The rats were individually ear-marked and kept in Macrolone cages Type III (42 x 26 x 15 cm) 2 or 3 to a cage, males and females separated. The bedding was pinewood sawdust ''Linocel Granulat'' from Company Altromin, 32791 Lage, Lippe. Regular analyses of bedding, diet, and drinking water are performed. Certificates of analysis are retained. The room temperature was 21 ± 3°C, and the relative humidity at 55 ± 15%. Air change 10 times per hour, and light from 06 to 18 h. The rats were kept in animal room No. 2.
- Diet (e.g. ad libitum): The rats were fed a complete rodent diet “Altromin 1326 from Company Altromin, 32791 Lage, Lippe ad libitum.
- Water (e.g. ad libitum): The rats had free access to drinking water acidified with hydrochloric acid to pH 2.5.
- Acclimation period: 5 days
The experiment was made on 10 (5 males and 5 females) SPF Wistar rats of the stock Mol:WIST from the MØIIegaard Breeding Centre Ltd., Ejby, DK-4623 Lille Skensved.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): light from 06 to 18 h
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Natriumcarboxymethylcellulose 1% and 0.1 ml Tween 80.
- Doses:
- The volume administered was 10 ml/kg body weight. The test article was administered orally by gavage to rats fasted for approximately 18 hours prior to dosing. After dosing the feed was withheld for a further 3 hours. The dosing took place between 09 and 10 h.
- No. of animals per sex per dose:
- 5 (5 males and 5 females)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Each rat was observed 1, 3 and 6 hours after administration and thereafter daily for a period of 14 consecutive days
- Necropsy of survivors performed: yes (all rats were killed with CO2 on day 14 and subjected to a gross autopsy examination).
- Other examinations performed: Body weights were recorded on day 0, 7 and 14 - Statistics:
- No details provided in report
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No male and no female rats died during the whole study
- Clinical signs:
- See Table 2 and Table 3 of the attached report for the pharmacotoxic clinical signs of the rats observed daily throughout the study.
- Body weight:
- Male: mean 149–247 g
Female: mean 141–186 g
The male and female rats had a normal body weight gain throughout the study. See Table 1 in attached report for body weights. - Gross pathology:
- Autopsy of the males showed in two animals a slight swelling of the liver and the edge of the liver was pale. Autopsy of the other male and female rats after two weeks observation period revealed no gross pathological finding.
- Other findings:
- Male: One hour after the application sedation and pinched abdomen were observed in two animals. The other 3 animals showed piloerection and pinched abdomen. Three hours after the application two animals were normal. Three and six hours after the application piloerection with or without pinched abdomen were observed in the other animals. From day 1 and throughout the rest of the 14 day observation period all animals showed a normal behaviour and appearance.
Female: One and three hours after the application all animals showed piloerection and pinched abdomen. After 6 hours only piloerection was observed. One animal showed piloerection on day 1. The other animals were normal. From day 2 and throughout the rest of the 14 day observation period all animals showed a normal behaviour and appearance.
Applicant's summary and conclusion
- Conclusions:
- No male and female rats died during the test period. The oral LD50 value for UKANOL DOP 95 in rats must be above 2000 mg/kg body weight.
- Executive summary:
The acute oral toxicity to rats was determined according to the method recommended in the OECD Guideline, ''Acute Oral Toxicity”, No. 401, Feb. 1987.
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