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EC number: 276-075-0 | CAS number: 71839-91-3
- 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
In a primary skin and eye irritation study, no skin or eye irritating effects were observed in New Zealand rabbits.
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
- 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)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: English Silver
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2 - 3 kg
- Housing: individually
- Diet: ad libitum (NAFAG, Gossau SG, rabbit food)
- Water: ad libitum, tap water - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- other: polyethylene glycol
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 g
VEHICLE
- Concentration: 50 % suspension - Duration of treatment / exposure:
- 24 h, substance was not washed off
- Observation period:
- 72 hours
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: flanks
- Type of wrap if used: plastic film
SCORING SYSTEM:
Erythema and Eschar Formation:
No erythema 0
Very slight erythema (barely perceptible) 1
Well defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4
Total possible erythema score 4
Edema Formation:
No edema 0
Very slight edema (barely perceptible) 1
Slight edema (edges of area well defined by definite
raising 2
Moderate edema (raised approximately 1 mm) 3
Severe edema (raised more than 1 mm and extending beyond area of exposure) 4
Total possible edema score 4 - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24/72h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Mean score for all six rabbits.
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24/72h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Mean score for all six animals.
- Irritant / corrosive response data:
- The test substance did not cause any treatment related irritation to the intact or abraded rabbit skin.
- Interpretation of results:
- GHS criteria not met
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
- 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 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: English Silver
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Housing: individually
- Diet: ad libitum (NAFAG, Gossau SG, rabbit food)
- Water: ad libitum, tap water - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Adjacent eye served as control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 g - Duration of treatment / exposure:
- 30 sec
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: 10 mL of lukewarm water
- Time after start of exposure: 30 sec.
SCORING SYSTEM:
Cornea
A. Opacity-degree of density (area most dense taken for reading)
No opacity 0
Scattered or diffuse area, details of iris clearly visible 1
Easily discernible translucent areas, details of iris slightly obscured 2
Opalescent areas, no details of iris visible, size of pupil barely discernible 3
Opaque, iris invisible 4
B. Area of cornea involved
One quarter (or less) but not zero 1
Greater than one quarter, but less than half 2
Greater than half, but less than three quarters 3
Greater than three quarters, up to whole area 4
A x B X 5 Total maximum = 80
Iris
A. Values
Normal 0
Folds above normal, congestion, swelling, circumcorneal injection (any or all of these or combination
of any thereof) iris still reacting to light (sluggish reaction is positive) 1
No reaction to light, hemorrhage, gross destruction (any or all of these) 2
A x 5
Conjunctivae
A. Redness (refers to palpebral and bulbar conjunctivae excluding cornea and iris)
Vessels normal 0
Vessels definitely injected above normal 1
More diffuse, deeper crimson red, individual vessels not easily discernible 2
Diffuse beefy red 3
B Chemosis
No swelling 0
Any swelling above normal (includes nictitating membrane) 1
Obvious swelling with partial eversion of lids 2
Swelling with lids about half closed 3
Swelling with lids about half closed to completely closed 4
C Discharge
No discharge 0
Any amount different from normal (does not include small amounts observed in inner-canthus of
normal animals) 1
Discharge with moistening of the lids and hairs just adjacent to lids 2
Discharge with moistening of the lids and hairs, and considerable area around the eye 3
(A -f B -I- C) X 2 Total maximum =20
TOOL USED TO ASSESS SCORE: hand-slit lamp - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- No irritating effects were seen in any of the animals.
- Interpretation of results:
- GHS criteria not met
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
In a primary dermal irritation study, six English silver rabbits (3/sex) were dermally exposed to 0.5 g of the test substance suspended in polyethylene glycol to the flanks (BASF, 1972). Test sites were covered with an occlusive dressing for 24 hours. Animals were then observed for 72 hours. Irritation was scored by the method of Draize et al. No erythema or edema was observed in any of the animals. In this study the test substance is not a dermal irritant.
In a primary eye irritation study, 0.1 g of the undiluted test substance was instilled into the conjunctival sac of the left eye of six English silver rabbits (3/sex) (BASF, 1972). 30 seconds after treatment the eyes of three rabbits were washed with lukewarm water. Animals were then observed for 7 days. Irritation was scored based on "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959). No eye irritating effects were seen in any of the animals neither with nor without rinsing of the eye. In this study, the test substance is not considered as an eye irritant.
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance does not need to be classified and labelled under Regulation (EC) No 1272/2008, as amended for the sixth time in Regulation (EC) No 605/2014.
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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