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EC number: 265-022-7 | CAS number: 64696-98-6
- 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
No irritant effects were recorded on skin and eye of the rabbit
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:
- 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Standard guideline study according to GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH 88353 Kißlegg
- Weight at study initiation: 2.0-2.2 kg
- Housing: single
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/- 3
- Humidity (%): 50 ± 20%
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- other: sesame oil
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg
- Concentration (if solution): 50 % suspension
VEHICLE
- Amount(s) applied (volume or weight with unit): 500µL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 h
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6,25 cm²
- Type of wrap if used: cellulose patch on a piece of surgical plaster
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm water after exposure
- Time after start of exposure: 4 hours - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 4-72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- a transient, very slight erythema was recorded at the end of exposure only
- Other effects:
- none
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results of this study test item is not irritating to skin.
- Executive summary:
PROCEDURE
About 24 hours before the start of the study the hair in the dorsal region of the body of 3 rabbits was removed with an electric clipper over an area of about 25 cm². Only animals with intact skin were used.
Each animal was treated with 0.5 g of the test item pasted with 0.5 ml sesame oil DAB 10.
The substance was administered over the whole surface of a 2.5 x 2.5 em cellulose patch on a piece of surgical plaster. The plaster was fixed to the prepared skin area and then covered with a semi-occlusive bandage .
The exposure period was 4 hours.
After the exposure period all remnants of the test substance were carefully removed from the skin with warm tap water.
Examinations of the skin took place after 30 - 60 minutes as well as 24, 48 and 72 hours after removal of the patches. Erythema, eschar formation and oedema were evaluated numerically according to the score of DRAIZE
All other changes of the skin were recorded.
RESULTS
30 - 60 minutes after decontamination two animals showed very slight erythema. 24 hours after decontamination all signs of irritation disappeared.
Based on the individual scores for erythema and oedema after 24, 48 and 72 hours, the following mean values were calculated: Erythema and eschar all animals: 0.0
Oedema formation all animals: 0.0
Conclusion
Based on the results of this study the test item is not irritating to skin.
Reference
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:
- 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Standard guideline study according to GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH 88353 Kißlegg
- Age at study initiation:
- Weight at study initiation: 3.3-3.9 kg
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/- 3
- Humidity (%): 50 ±20%
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 100 mg/eye
- Duration of treatment / exposure:
- single instillation , rinsing after 24 h
- Observation period (in vivo):
- 3 days (72 h)
- Number of animals or in vitro replicates:
- 3
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 0-72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 0-72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 0-72 h
- Score:
- 0.55
- Max. score:
- 1
- Reversibility:
- fully reversible within: 3 days
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Testing for primary eye irritation in the rabbit showed, that the substance is not irritating to eye.
- Executive summary:
Procedure
100 mg of the test item were administered once to the conjunctival sac of the left eyes of three rabbits. The untreated eyes served in each case as a control. 24 hours after administration and at all other designated examination times at which the treated eyes still showed discharge or at which a corneal examination with fluorescein sodium solution took place, the treated eyes were washed out thoroughly with isotonic saline at approx. 37 °C.
The eyes were examined 1, 24, 48 and 72 hours after administration of the test substance. At 24 and 72 hours, the eyes were also examined for corneal lesions under UV light after instillation of one drop of a 0.01 % fluorescein-sodium solution. Lesions in cornea, iris or conjunctivae were graded numerically. All other changes or toxic effects were recorded.
RESULTS
One hour up to 48 hours after administration the conjunctivae of the animals showed definitely injected blood vessels and sporadically very slight swellings. Additionally, serous eye discharge was noted. Four days after administration all signs of irritating were reversible.
Opacity of cornea all animals 0.0
Iris all animals 0.0
Redness of conjunctiva all animals 0.55
Chemosis of conjunctiva all animals 0.0
Testing for primary eye irritation in the rabbit showed, that the substance is not irritating to eye.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
only valid available study
Justification for selection of eye irritation endpoint:
most recent and most valid study
Justification for classification or non-classification
No classification
No irritant effects were observed in studies for skin and eye irritation on rabbits.
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