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EC number: 418-780-1 | 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
Testing of Beta W 7 A 1.0 for primary eye irritation in the rabbit according to OECD 405 showed that the substance is not irritating to eye.
Testing of Beta W 7 A 1.0 for primary dermal irritation in the rabbit according to OECD 405 showed that the substance is not irritating to skin.
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:
- 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD Guideline Study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- New Zealand albino rabbit
Charles River Deutschland GmbH
88353 Kißlegg
3 animals
3.4 - 3.6 kg b.w. at start of study
numbered ear tags for identification - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- other: Polyethylenglycol 400 (0,5 mL)
- Controls:
- other: untreated skin
- Amount / concentration applied:
- 500 mg per patch
- Duration of treatment / exposure:
- 4 h
- Observation period:
- see details on study design
- Number of animals:
- 3 animals
- Details on study design:
- 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 Beta W 7 A 1.0 pasted with 0.5 ml
Polyethylenglycol 400 (Riedel de Haen Aktiengesellschaft). The substance was
administered over the whole surface of a 2.5 x 2.5 em cellulose patch on a piece of
surgical plaster (specially produced by Beiersdorf Aktiengesellschaft). 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 (see Appendix "Scale for scoring dermal reactions", page 11). All
other changes of the skin were recorded. - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Max. score:
- 0
- Remarks on result:
- other: Max. duration: d; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Max. score:
- 0
- Remarks on result:
- other: Max. duration: d; Max. value at end of observation period: 0 (related to all animals)
- Irritant / corrosive response data:
- One hour after removal of the patch the treated skin of the animals showed very slight
erythema. One day after removal of the patch the irritations were reversible.
Based on the results of this study Beta W 7 A 1.0 is not irritating to skin. - Other effects:
- One hour after removal of the patch the treated skin of the animals showed very slight
erythema. One day after removal of the patch the irritations were reversible.
Based on the results of this study Beta W 7 A 1.0 is not irritating to skin. - Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Testing of Beta W 7 A 1.0 for primary dermal irritation in the rabbit according to OECD 405 showed that the substance is not irritating to skin.
- Executive summary:
Testing of Beta W 7 A 1.0 for primary dermal irritation in the rabbit according to OECD 405 showed that the substance 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:
- 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD Guideline Study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- New Zealand albino rabbit
Charles River Deutschland GmbH 88353 Kißlegg
3 animals
3.5 - 3.9 kg b.w. at start of study
numbered ear tags for identification - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- see details on study design
- Observation period (in vivo):
- see details on study design
- Number of animals or in vitro replicates:
- 3 animals
- Details on study design:
- About 24 hours before the start of the study the test eyes of all animals were examined
under UV light for comeallesions after instillation of one drop of a 0.01 %
fluorescein-sodium solution. Only animals without ocular abnormalities were used for
the study.
100 mg Beta W 7 A 1.0 was administered once to the conjunctival sac of the left eye
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 (see Appendix "Scale for scoring
ocular reactions" page 11 and 12). All other changes or toxic effects were recorded. - Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0.33
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0.66
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0.33
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Max. score:
- 1
- Remarks on result:
- other: Max. duration: 48 h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Max. score:
- 0
- Remarks on result:
- other: Max. duration: 0 h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Max. score:
- 0
- Remarks on result:
- other: Max. duration: 0 h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Max. score:
- 0
- Remarks on result:
- other: Max. duration: 0 h; Max. value at end of observation period: 0 (related to all animals)
- Irritant / corrosive response data:
- Reversibility of any observed effect: changes fully reversible within 2 days.
- Other effects:
- One hour up to one day after application the conjunctiva of the animals showed
definitely injected blood vessels up to more diffuse deeper crimson red colours and
slight swellings of lids. The irritations were attended by clear coloured eye discharge.
Two days p.a all irritations were reversible. - Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- Testing of Beta W 7 A 1.0 for primary eye irritation in the rabbit according to OECD 405 showed that the substance is not irritating to eye.
- Executive summary:
Testing of Beta W 7 A 1.0 for primary eye irritation in the rabbit according to OECD 405 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
Testing of Beta W 7 A 1.0 for primary eye irritation in the rabbit according to OECD 405 showed that the substance is not irritating to eye. Testing of Beta W 7 A 1.0 for primary dermal irritation in the rabbit according to OECD 405 showed that the substance is not irritating to skin.
Justification for selection of skin irritation / corrosion endpoint:
OECD Guideline Study
Justification for selection of eye irritation endpoint:
OECD Guideline Study
Justification for classification or non-classification
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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