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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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- 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:
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- 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 - 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
- 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. - 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.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- November 16 2012 - January 4 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Modern, guideline, GLP study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- control animal included
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Animal breeding facility, JRF
- Age at study initiation: 8 to 14 weeks
- Weight at study initiation: males 268-300; females 203-221
- Fasting period before study: no
- Housing: individually in polypropylene cages with stainless steel grid tops.
- Diet: Teklad Certified Global High Fiber Rat/Mice Feed manufactured by Harlan, USA ad libitum
- Water: UV sterilised and reverse osmosis filtered water ad libitum
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23
- Humidity (%): 65-66
- Air changes (per hr): min 15
- Photoperiod: 12 hrs dark /12 hrs light (light 06:00 - 18:00)
IN-LIFE DATES: From: 19 Nov 2012 To: 11 Dec 2012 - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- moistened with water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorso lumbar area of trunk
- % coverage: ~ 10
- Type of wrap if used: porous gauze dressing (not more than 8-ply) and a non-irritating tape (Medi tape 330 hypo-allergenic surgical tape)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): cotton wool soaked in distilled water
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 406-600 mg (2000 mg/kg)
- For solids, paste formed: pulverised and moistened with 0.2 mL distilled water - Duration of exposure:
- 24 hours
- Doses:
- single
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: at least twice per day for morbidity and mortality. Clinical signs once daily, body weights on day 0, 7 and 14.
- Necropsy of survivors performed: yes - Statistics:
- body weight was statistically analysed by Student's "t" test.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality, no signs of systemic toxicity and no abnormalities at necropsy at only dose tested
- Mortality:
- There were no mortalities
- Clinical signs:
- No signs of toxicity were observed
- Body weight:
- Mean body weight of treated group was comparable to controls
- Gross pathology:
- There were no lesions of pathological significance
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- In an OECD guideline acute dermal toxicity study using groups of 5 males and 5 females the acute dermal median lethal dose of HCA was > 2000 mg/kg.
- Executive summary:
Two groups of 5 male and 5 female rats were clipped and 0.2mL of distilled water or 2000 mg/kg HCA applied to an area of skin equal to approximately 10% of the body surface. The test site was covered with a semi-occlusive dressing for 24 hours, when it was removed and test site washed with distilled water. The animals were observed daily for signs of systemic toxicity and weighed at intervals during a 14 day observation period. At the end of the study the animals were killed and examined post mortem.
There were no mortalities, no signs of systemic toxicity, no treatment related effects on body weight and no abnomalities at necropsy.
The acute dermal median lethal dose of HCA was > 2000 mg/kg.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
Oral toxicity:
- Assessment of Acute Oral Toxicity in Rats: 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.
- Subacute Toxicity Experiment of HCA (Synthetic Resin Stabilizer): A subacute toxicity test of HCA was performed by administering the feed added with 0, 0.24, 0.6 and 1.5% of HCA to rats for 16 weeks.
As a result, it was concluded that the limit dose of HCA in the feed was between 0.6% and 1.5%. In tens of 1 kg of body weight, this maximum dose comes to 0.399 ~ 1.023 g/day for males and 0.445 ~ 1.094 g/day for males, or 0.419 ~ 1.052 g/day on average.
Justification for classification or non-classification
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.
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