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Diss Factsheets
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EC number: 701-340-9 | CAS number: -
- 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
Skin irritation:
Not irritationg, key study with 6 albino rabbits following 24 hours occluded contact with the test material according to the procedure described in the U.S.Federal Register, 1973, Vol.38, No.187, Section 1500:41 (similar to OECD Guideline 404).
Eye irritation:
Study scientifically unjustified as the test substance has been used safely in humans for many years as a cosmetic in the area of the eyes. This result is supported by publication data which confirm that the test substance is slightly irritating to non-irritating to eyes.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 8th July 1981 to 11th July 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Test method is similar to OECD guideline 404. No GLP study.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- - Principle of test: Procedure according to US Federal Register, 1973, Vol. 38, No. 187, Section 1500: 41.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Recognised breeders whose premises have been inspected by Toxicol Laboratories
- Weight at study initiation: 2.55-2.66 Kg
- Housing: Grid bottomed galvanised metal cages
- Diet (e.g. ad libitum): ninety to ninety five grams of a commercially available pelleted rabbit diet (Product Ref.16934, Spillers Agriculture Limited) for each animal at a similar time each day
- Water (e.g. ad libitum): an automatic watering system provided a constant supply of drinking water to the cages
ENVIRONMENTAL CONDITIONS
- Temperature (°C): air -conditioned room
- Photoperiod (hrs dark / hrs light): 14 hours light/10 hours dark per day - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- 0,5g aliquots of the test material were moistened with 0,5ml sterile distilled water.
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- One hour was allowed to permit any irritation from the adhesive tapes
24 hour observation
72 hour observation - Number of animals:
- 6
- Details on study design:
- TEST SITE
-Area shaved: 10% of the total dorsal surface area. The left flank was then lightly abraded with the point of a 25x0.6mm sterile disposable hypodermic needle.
-Area of exposure: 0.5g of the test sample was applied to each of two 2.5cm square surgical lint pads attached to "Sleek" plastic adhesive wrapping (one square with abraded skin and other square with intact skin) - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- No irritant/corrosive effects were noted
- Other effects:
- No general toxic effects were noted
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material is not classify as a "primary irritant to the skin". It would be regarded as a mild irritant to the skin of the albino rabbit according to the Draize system of classification.
- Executive summary:
The aim of this study was to investigate the degree of irritation produced to the abraded and intact skin of 6 albino rabbits following 24 hours occluded contact with the test material. The procedure used is that described in the U.S.Federal Register, 1973, Vol.38,No.187, Section 1500:41 (similar to OECD Guideline 404). 0.5 g of the test sample was applied to each of two 2.5cm square surgical lint pands attached to "Sleek" plastic adhesive wrapping. The duration of the exposure was 24 hours. Skin examinations were conducted at 24, 72h after patch removal. The average scores produced by the group of 6 rabbits were 0.0 for erythema and 0.0 for oedema, giving a primary irritation score of 0.0. No reactions were observed throught the study.
The test substance is considered as non-irritating to the skin.
Reference
No irritant/corrosive effects were noted
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
Information based on experience in the use of the substance as a cosmetic product shows that the substance is not irritant to the eyes. - Reason / purpose for cross-reference:
- data waiving: supporting information
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation:
Key study. Study with 6 albino rabbits following 24 hours occluded contact with the test material. The procedure used was described in the U.S.Federal Register, 1973, Vol.38, No.187, Section 1500:41 (similar to OECD Guideline 404). The result was as follows: 0.0 for erythema and 0.0 for oedema, giving a primary irritation score of 0.0. No reactions were observed throught the study.
Eye irritiation:
Study scientifically unjustified as the test substance is used in humans for so many years as a safely cosmetic in the area of the eyes. This result is supported by publication data which confirm that the test substance is slightly irritating to non-irritating to eyes.
Justification for selection of skin irritation / corrosion endpoint:
Only one study available.
Justification for selection of eye irritation endpoint:
Data waiving: Study scientifically unjustified.
Justification for classification or non-classification
Based on the available data, the substance is not classified for irritation/corrosion according to CLP Regulation (EC) No 1272/2008.
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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