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EC number: 619-636-0 | CAS number: 125971-57-5
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1995-05-29 to 1995-07-06
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD Guideline No. 406 under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted 1992
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): BIBEA/A
- Expiry date: December 1996
- Storage: ambient, protected from light
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright white
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann, Borchen, Germany
- Age at study initiation: not specified
- Weight at study initiation: male: 370-433 g; female: 365-498 g
- Housing: collective housing up to a maximum of 5 animals per cage (Makrolon type IV)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3 °C
- Humidity (%): 30-70%
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: various vehicles, see concentration
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: various vehicles, see concentration
- No. of animals per dose:
- Number of animals in test group: 20
Number of animals in negative control group: 10 - Details on study design:
- RANGE FINDING TESTS:
2 animals for range finding for intradermal injection
2 animals for range finding for dermal application
MAIN STUDY
A. INDUCTION EXPOSURE
Test group:
First stage - Intradermal three pairs of intradermal injections at the shoulders of the animals: 0.1 mL of a 5% dillution of the test article in peanut oil and 0.1 mL of a 5% dillution of thetest article in Freund's complete adjuvant/water and 0.1 mL of a 50% dillution of Freund's complete adjuvant in water
Second stage afer 7 days - dermal application at the shoulder of the animals: 50 % in Vaseline over an area 4x5cm for 48 h
Control group:
First stage - Intradermal three pairs of intradermal injections: 0.1 mL of peanut oil and 0.1 mL of a 50% dillution of Freund's complete adjuvant in water and 0.1 mL of a 50% dillution of Freund's complete adjuvant in peanut oil.
Second stage afer 7 days - dermal application: Vaseline over an area 4x5cm.
Both groups: 24 hours before the dermal application of the test article the area was treated with 10% sodium lauryl sulfate in vaseline to induce a mild inflammation.
B. CHALLENGE EXPOSURE (14 days after the second stage of induction)
Concentration of test material and vehicle used for each challenge in the test and the control group:
50% in vaseline to the left flank 100% vaseline to the right flank over an area of 5x5 cm. - Challenge controls:
- The reaction to the positive control substance 2,4-dinitrochlorobenzene is tested periodically. The last test with acceptable levels of responses to this substance (mild or moderate sensitizer in dependence on the concentration) was performed from December 16, 1994 till January 9, 1995.
- Positive control substance(s):
- yes
- Remarks:
- 2,4-dinitrochlorobenzene
Study design: in vivo (LLNA)
- No. of animals per dose:
- 20 animals (10 male, 10 female) in the test group
10 animals (5 male, 5 female) in the control group - Statistics:
- individual analysis according to the Draize system and report of the sensitizing rate in %
Results and discussion
- Positive control results:
- see above
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The test article BIBEA/A is a non-sensitizer under applied test conditions.
- Executive summary:
The potential skin sensitizing properties of BIBEA/A were assessed in the guinea pig maximization test using 20 test and 10 control animals. Following induction exposure to the test article or the vehicle, the animals were subjected two weeks later to a challenge exposure with test article. The treated skin areas were evaluated 24 and 48 hours after the end of the exposure period. The sensitating rat was 0% at 24 and 48 hours.
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