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EC number: 275-640-9 | CAS number: 71566-55-7
- 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
A skin irritation test showed no edema and no histological changes.
An eye irritation test showed no effects on the 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:
- 1972
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- other: "Appraisal of the Safety of Chemicals in Foods, Drogs and Cosmetics" published by the Editorial Committee of the Association of Food and Drug Officials of the United States of America.
- Version / remarks:
- 1965
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 3-5 months
- mean weight at study initiation: males 2.90 kg, females 2.73 kg
- Housing: Rabbits were caged singly in a room.
- Diet: commercial irradiated diet (Styles-Oxoid) was fed ad libitum and sterile filtered water was available at all times.
- Acclimation period: six rabbits were maintained under pretest conditions for one week prior to the test
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20
- Humidity (%): 50-70
- Photoperiod (hrs dark / hrs light): Animals were exposed to fifteen hours of artificial light from 8.00 hours to 23.00 hours daily. - Type of coverage:
- occlusive
- Preparation of test site:
- other: abraded and shaved
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg of the test substance was mixed with 0.5 mL 66 OP Industrial Spirit - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Application side: back
- % coverage: at least 10% of the total body surface
- Type of wrap if used: aluminium foil secured with "sleek" adhesive tape, which was in turn covered by Coban 6 wide self-adhering elastic bandages - Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24h, 72h
- Score:
- 0.09
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- after 72 h
- Remarks on result:
- other: abraded skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24h, 72h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: intact skin
- Irritant / corrosive response data:
- Due to the staining of the stratum corneum by the test compound, it was impossible to assess the degree of erythema.
- Interpretation of results:
- GHS criteria not met
Reference
Histopathological report on Biopsy Specimens:
One animal No. 15 revealed a minimal acanthosis of the epidermis. This lesion is of little significance and is such as might be caused by clipping and cleaning the area of skin involved.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1972
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- according to guideline
- Guideline:
- other: Regulation under the Federal Hazardous Substance Labelling Act (February 1965) Part 191.12(b)(2)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 3-5 months
- mean body weight at study initiation: males 2.90 kg and females 2.73 kg
- Housing: 6 rabbits were maintained under pretest conditions for one week prior to to the test.
- Diet: a commercial irradiated diet /Styles-Oxoid) was fed ad libitum
- Water: water was available at all times.
ENVIRONMENTAL CONDITIONS
- Temperature: 20 °C
- Humidity: 50 - 70%
- Photoperiod (hrs dark / hrs light): animals were exposed to fifteen hours of artificial light from 08.00 hours to 23.00 hours daily. - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 25 mg (= 0.1 mL bulk volume) - Duration of treatment / exposure:
- single treatment
- Observation period (in vivo):
- 72h
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- - the test substance was applied into the conjunctival sac of the left eye. The eyelids were then closed for one second.
- the non-treated left eye served as control
- the test substance was not washed out - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24h - 72h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24h - 72h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24h - 72h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24h - 72h
- Score:
- 0
- Max. score:
- 3
- Interpretation of results:
- GHS criteria not met
Reference
Clinical Symptoms:
1 hour: Very mild ptosis present in one animal (male)
2. hours. Very mild ptosis present in one male and one female
4 hours: All animals normal and remained normal until autopsy
The nature of the material precluded any further detailed assessment at the times other than the examination of the lids and evidence of chemosis.
Autopsy:
No lesions attributed to the compound were found
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
An acute skin irritation study with New Zealand White rabbits was performed (Ciba-Geigy, 1972) according to the method in the "Appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics" published by the Editorial Committee of the Association of Food and Drug Officials of the united States of America (1965). Twenty-four hours prior the dermal application, the backs of the rabbits were shaved over an area constituting at least 10% of the total body surface. On each rabbit two test sites located at the mid-line of the back, were used. Immediately before application the right hand site was abraded, the left hand site remained intact. 500 mg of the test substance was mixed with 0.5 mL 66 OP Industrial Spirit and applied to each test site on a gauze pad approximately 2.5 x 2.5 cm. The test sites were covered with an occlusive dressing for 24 hours. Due to substance-colored skin, it was impossible to assess the degree of erythema. The test substance did not cause any irritation on the intact skin of the test animals (mean edema score (24, 72 h) of 0 and no histological signs of an effect). One animal with abraded skin developed very slight edema at 24 hours. A mean edema score (24, 72 h) of 0.09 awas observed on the abraded skin. The observed edema effect was fully reversible within 72 hours. Because of the findings regarding the intact skin, the test substance is not considered irritating to the skin.
An acute eye irritation study with New Zealand White rabbits was performed (Ciba-Geigy, 1972) according to the procedure set out in the Regulations under the Federal Hazardous Substances Labelling Act (February 1965) Part 191.12. 25 mg of the test material, equivalent to 0.1 mL volume was instilled into the conjunctival sac of the left eye of 6 Vienna White rabbits. The eyelids were then closed for one second and the test substance was not washed out. The eyes were examined at the following times after application of the test substance: 1, 2, 4, 24, 48 and 72 hours. At no time an irritation of the eye was observed (mean score of six animals (24,48,72 h) = 0). Based on the results of this study, the test substance is not considered irritating to the eye.
Justification for classification or non-classification
Based on the available information classification for skin and eye irritation is not warranted in accordance with EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation 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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