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Diss Factsheets
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EC number: 428-190-4 | CAS number: 68490-66-4 CUREZOL 2MA-OK
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: Draize, J.H. (1959). Dermal toxicity. Appraisal of the safety of chemicals in foods, drugs and cosmetics. The Assoc. of Food and Drug Officials of the United States. Texas State Dept. of Health, Austin, TX, p. 46
- Version / remarks:
- 1959
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- other: New dermatological physiology and safety (evaluation of the toxicity of contact chemical substances), edited by Yoshio Takase, Hideyo Ogawa, and Kikuhiko Okamoto (Seishi Shoin)
- Version / remarks:
- 1973 Federal Register method
- Deviations:
- not specified
- Principles of method if other than guideline:
- - Principle of test: Intact and abraded sites of skin are exposed to the test material, under occlusive bandaging for a period of 24 hours, after which each site is graded for both erythema and edema at 24, 48, and 72 hours, and 4 and 5 days after application.
- Short description of test conditions: Two shaved intact and two shaved abraded skin sites per animal, in 6 animals, are exposed to the test material under occlusive bandaging for contact with these areas of skin for 24 hours, after which erythema and edema are graded per skin location at 24, 48, and 72 hours, and 4 and 5 days after application. The 4 application sites per animal consist of 1) 100% test material on intact skin, 2) 100% test material on abraded skin, 3) 50% (w/w) test material in petrolatum on intact skin, 4) 50% (w/w) test material in petrolatum on abraded skin.
- Parameters analysed / observed: The intact and abraded skin sites for each treatment in each of the 6 animals used on test were graded by naked eye using Draize scoring for erythema and crust formation, and for edema formation. An irritation index was determined using the sum of the total erythema points plus the total edema points, and then dividing by the number of animals (6).
1) The Primary Irritation Index (P.I.I.) was calculated by adding all 8 scores obtained for each animal, dividing the sums obtained by 4, and calculating the average for 6 animals. A P.I.I. of 0 to 2 according to the Draize score methodology equates to an irritation rating of "Slightly irritant."
2) The degree of irritation in the intact skin was evaluated by adding all 4 scores obtained from each animal, dividing the sums obtained by 4, and calculating the average for 6 animals. According to the method of Campbell et al, the test material resulted in an evaluation of "not irritant and safe for application to intact skin." - GLP compliance:
- no
Test material
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Japanese White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.5 to 3 kg
- Housing: stainless steel caging
- Diet: Pellet feed (RC4; Oriental Yeast Co., Ltd.), ad libitum
- Water: municipal tap water, ad libitum
- Acclimation period: at least one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.5 ± 2.5
- Humidity (%): 50-70
- Photoperiod (hrs dark / hrs light): 16 / 8
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- 50% (w/w) using petrolatum was also tested
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 500 mg
- Duration of treatment / exposure:
- 24 h
- Observation period:
- 5 days
Reading time points: 24, 48 and 72 h, and 4 and 5 days - Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: Four 1 inch diameter areas of flank skin on each animal
- Type of wrap if used: fabric bandage
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 h
OBSERVATION TIME POINTS
24, 48, and 72 h, and 4 and 5 days
SCORING SYSTEM
Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- 100%
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- 100%
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- 50% (w/w) using petrolatum was also tested and no irritation was observed (score 0 at all observation time points)
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria are not met, no classification required according to Regulation (EC) No 1272/2008.
- Conclusions:
- In this primary skin irritation study in rabbits, the test material showed no irritant effect on either intact or abraded skin at 100% or 50% (w/w; in petrolatum), indicating that it is a non-irritant.
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