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EC number: 479-880-7 | CAS number: 97042-18-7
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22 October to 16 November 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study undertaken at GLP accredited laboratory to internationally accepted guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- BPS-MAE
- IUPAC Name:
- BPS-MAE
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): BPS-MAE
- Physical state: White powder
- Analytical purity: > 99%
- Lot/batch No.: G120903
- Expiration date of the lot/batch: 01 March 2003
- Storage condition of test material: Ambient
Constituent 1
In vivo test system
Test animals
- Species:
- rabbit
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Commercial laboratory animal supplier.
- Age at study initiation: 5 weeks
- Weight at study initiation:
- Housing: in a mobile battery, containing 6 cages; maximal 10 animals per cage.
- Diet (e.g. ad libitum): standard laboratory diet ad libitum.
- Water (e.g. ad libitum): Tap water (N.V. Hydron Midden Nederland) ad libitum.
- Acclimation period:12 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3°C
- Humidity: 30 - 70%
- Air changes: ca. 10 air changes per hour.
- Photoperiod: 12 hrs dark / 12 hrs light
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- maize oil
- Concentration / amount:
- Concentration of test material and vehicle used at induction: Induction treatment by intradermal injections of Freund's Complete Adjuvant (FCA) 1:1 dilution with physiological saline, a 0.3 % test dilution of the test substance in maize oil, and a 0.3 % test dilution of the test substance in FCA/maize oil, followed one week later by topical application of a 30 % test dilution of the test substance in maize oil. Concentration of test material and vehicle used for each challenge: 14 days after the last induction, by topical application of a 3 % dilution of the test substance in maize oil and maize oil alone.
Challengeopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- maize oil
- Concentration / amount:
- Concentration of test material and vehicle used at induction: Induction treatment by intradermal injections of Freund's Complete Adjuvant (FCA) 1:1 dilution with physiological saline, a 0.3 % test dilution of the test substance in maize oil, and a 0.3 % test dilution of the test substance in FCA/maize oil, followed one week later by topical application of a 30 % test dilution of the test substance in maize oil. Concentration of test material and vehicle used for each challenge: 14 days after the last induction, by topical application of a 3 % dilution of the test substance in maize oil and maize oil alone.
- No. of animals per dose:
- Number of animals in test group: 10
Number of animals in negative control group: 5 - Details on study design:
- RANGE FINDING TESTS:
The irritation response to intradermal injection of various concentrations of the test substance was examined in 2 guinea pigs. A sufficiently large area ofthe flanks was clipped free from hair with electric clippers. Amounts of 0.1 ml of the selected concentrations were applied by intradermal injection. Circa 24 hours after injection, the animals were examined for signs of irritation. A concentration causing slight to moderate irritation but otherwise well-tolerated by the animals, is usually taken for intradermal injection of the test substance in the induction phase of the main study. The irritation response to topical treatment ofvarious concentrations of the test substance was examined in 2 other guinea pigs. The flanks of each of the animals were clipped free from hair with electric clippers. Patches (Silverpatch, v.d. Bend B.V., nBrielle, the Netherlands) were loaded with the test material and placed on the clipped skin of each animal, and covered with a piece of hypoallergenic paper bandage (Leukopor) that was secured by elastic adhesive bandage (Tensoplast), wound around the torso of the animal. The dressing was left in place for ca. 24 hours. Circa twenty four and 48 hours after removal of the dressing, the animals were examined for signs of skin irritation. A concentration causing slight to moderate skin irritation is usually chosen for topical induction and a non-irritant concentration for topical challenge.
B. CHALLENGE EXPOSURE
Fifteen guinea pigs were randomly divided into two groups, viz. one test group of 10 animals and one control group of 5 animals. The animals were weighed one day before the study was initiated and at the completion ofthe study.
Induction was effected in two different ways, firstly by intradermal injections and secondly, one week later, by topical application over the injection sites.
a. Intradermal injections
For this purpose an area of about 24 cm2 of dorsal skin in the scapular region was clipped free from hair with electric clippers. Pairs of intradermal injections (0.1 ml each) were made simultaneously in the clipped area.
The following preparations were injected:
test animals
- two injections with Freund's Complete Adjuvant (FCA)/physiological saline (1: 1),
- two injections with the selected test concentration,
- two injections with the selected test concentration in FCA Ivehicle (1:1),
control animals
- two injections with FCAIphysiological saline (1: 1),
- two injections with the vehicle,
- two injections with FCAIvehicle (l: 1).
Skin readings were made at ca 24 hours after the treatment.
b. Topical application
Six days after the intradermal injections, the dorsal skin in the scapular region of all test and control animals was closely clipped again. On the following day, the induction by topical application was made in this region. The test animals were treated as follows: A circa 2 x 4 cm patch ofWhatman No.3 MMfilter paper was loaded with the selected concentration ofthe test substance (see table 1). The loaded patch was placed over the sites ofthe intradermal injections and was secured as described in section 2.3.1. The dressing was left in place for ca 48 hours. The controls were similarly treated with a patch loaded with the vehicle. Skin readings were made directly after removal ofthe patches.
The topical challenge with the test substance was carried out 14 days (test animals) or 15 days (controls) after the topical induction as follows:
An area ofcirca 5 x 5 cm on both flanks of each test and control animal was clipped free from hair. Patches were loaded with the test concentration selected and with the vehicle alone. Subsequently, the loaded patches were placed on the clipped area of the flank ofeach test and control animal. The patches were covered with Leukopor bandage, and held in place by Tensoplast for ca 24 hours. Skin readings were made at
ca 24 and 48 hours after removal ofthe patches. - Challenge controls:
- No data
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 3 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 3 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 3 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 3 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 3 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 3 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 3 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 3 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Any other information on results incl. tables
Maximum concentration not causing irritating effects in preliminary test: .3 %
Signs of irritation during induction:
The intradermal injections generally caused the following
skin reaction:
FCA / physiological saline (1:1): moderate
Vehicle: no skin reactions
FCA / vehicle (1:1): moderate erythema
After the topical application of the vehicle alone, no skin
reactions were observed in controls.
Evidence of sensitisation of each challenge concentration:
At 24 and 48 hours after the challenge treatment with the
test substance, none of the controls or test animals showed
any skin reaction.
None of the controls or test animals showed any skin
reaction at 24 and 48 hours after challenge with the vehicle
alone.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Since none of the test animals showed positive signs of sensitization, it can be concluded that, according to the EC standards, the test substance is not a sensitizer.
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