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EC number: 478-920-0 | CAS number: 457632-32-5
- 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
one study on skin sensitisation comparable to Guideline study
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 31. May - 24. July 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Test conducted before adoption of LLNA Guidelines
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 0-3-A
- Expiration date of the lot/batch: not stated
- Purity test date: not stated
RADIOLABELLING INFORMATION (if applicable)
not applicable
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: not stated
- Stability under test conditions: not stated
- Solubility and stability of the test substance in the solvent/vehicle: not stated
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: not stated
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
not stated - Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: not stated
- Females (if applicable) nulliparous and non-pregnant: not specified
- Microbiological status of animals, when known: SPF, not further specified
- Age at study initiation: 4-6 weeks
- Weight at study initiation: 425 - 465 (test group)
- Housing: not state d
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days
- Indication of any skin lesions: checked at acclimation start, none reported
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 60 ° - 80° F
- Humidity (%): 30 - 70
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): 12/12
- IN-LIFE DATES: From: To: - Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- 20 % stock solution for intradermal injection and topical application
- Day(s)/duration:
- 48 h topical application
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
- No.:
- #1
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- water
- Concentration / amount:
- 20 % stocksolution, at 50 % in distilled water, 0.4 mL
- Day(s)/duration:
- 24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 5
- Details on study design:
- Two (2) weeks after the topical induction applications, the challenge applications were made.
Prior to dosing, a five by five (5 x 5) cm area of the flank of each guinea pig, in the test groups
for the test and positive control aiticle, as well as the negative control groups for each article, was
shaved as detailed previously. The test or positive control articles, at the screen detennined
highest non-irritating concentrations, were applied to the flanks of the appropriate animals.
Four-tenths (0.4) of a milliliter of each article was applied to each site via a 25 mm Hilltop
Chamber (with the cotton patch). The animals were wrapped after dosing, with a piece of three
(3) inch Elastoplast® elastic tape, that had been lined on the adhesive side with a three (3) inch
wide strip of Pure Latex Dental Dam. The wraps remained in place for 24 hours. Twenty-one
hours after unwrapping, any remaining article was removed with an ethanol wipe and the test site
was shaved if necessary. Three hours later, the test site was scored according to the attached
Draize Scale (Table 1). Twenty-four and 48 hours later, the sites were again scored.
Two (2) indices were calculated from the erythema scores for each article, one (1) to evaluate the
incidence of erythema (reaction) and the other to evaluate the severity of erythema. The indices
for incidence and severity were calculated for the control groups and for the induction groups
from the erythema responses observed at the 48, 72 and 96 hour post-challenge examinations.
The incidence index was calculated by counting the number of animals showing an erythema
response [one (1) or greater] for a specified time period and dividing by the number of test sites
(animals) examined at the time period (# responses/# per group). The seve1ity index was
calculated by adding the erythema scores [one (1) or greater] for a specified time period and
dividing by the number of scores added (sum of erythema scores/# scores added). The two (2)
indices were used to evaluate the sensitization potentials of the articles. The edema scores were
noted but were not used in the calculation of any indices.
Initial and terminal body weights were recorded for the non-screen animals. Sacrificing was
accomplished via carbon dioxide asphyxiation. All animals appeared healthy throughout the
study. - Challenge controls:
- 20 % test article stock solution of 20 % in distilled water, at 50 %
- Positive control substance(s):
- yes
- Positive control results:
- the positive control substance resulted in effects characteristic for skin sensitzers.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 20 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- all animals appeard healthy throughout the study
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.05%
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Clinical observations:
- all animals appeard healthy throughout the study
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- all animals appeard healthy throughout the study
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Executive summary:
Five (3M:2F) Hartley-strain albino, outbred, viral antibody free, guinea pigs (SPF
Ha1tley guinea pig Aai: (HA) Outbred), 425 - 465 grams, were utilized as the test
group. An additional five (2M:3F) Hartley-strain guinea pigs, 378 - 450 grams,
were utilized as the control group. For induction, each animal in the test group
received three (3) pairs of intradennal injections, with and without the test a1ticle.
Dming the second week of the induction phase, topical applications of the test
article were made to the induction site of each animal in the test group. Two (2)
weeks after the topical induction applications, the challenge applications were
made. These 24 hour challenge applications were made to virgin sites on the
flank of each animal in the test and control groups, at the screen detennined,
highest non-irritating concentration of 10% in distilled water. Observations of
erythema, edema and other effects were recorded 48, 72 and 96 hours after the
challenge applications. The test article was prepared as a 20% suspension (stock
solution) in distilled water, that had been heated at approximately 70° C for 30
minutes. The mixture was allowed to cool prior to use.
Results:
Index:
Incidence
Severity
Group
Test/Control
Test/Control
Scoring Interval:
0/0
0/0
48 Hours:
0/0
0/0
72 Hours:
0/0
0/0
96 Hours:
0/0
0/0
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
according to Guidance on information and chemical safety assessement, Chapter R.7a, ECHA, the conclusion on the endpoint is derived.
Justification for classification or non-classification
The presented information is conclusive but not sufficient for classification.
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