Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 440-870-2 | CAS number: 1013-88-3
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The LLNA method was not established yet by the time the study was conducted.
Test material
- Reference substance name:
- -
- EC Number:
- 440-870-2
- EC Name:
- -
- Cas Number:
- 1013-88-3
- Molecular formula:
- C13 H11 N
- IUPAC Name:
- C,C-Diphenylmethyleneimine
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): BPI (Benzophenone imine)
- Analytical purity: 94.8 %
- Lot/batch No.: 11/94 container 13
- Physical state: liquid, light yellow
- Storage condition of test material: refrigerator
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River GmbH, Wiga, Kisslegg, FRG
- Age at study initiation: young adult animals
- Weight at study initiation: 318 - 350 g
- Housing: 5 animals per cage in Makrolon type IV cages
- Diet: Kliba Labordiaet 341 (Klingentalmuehle AG, Kaiseraugst, Switzerland) ad libitum
- Water: ad libitum (tap water; about 2 g of ascorbic acid per 10 L water was added to the drinking water twice a week)
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12 (6.00 pm - 6.00 am dark, 6.00 am - 6.00 pm light)
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- olive oil
- Concentration / amount:
- Intradermal induction: 1%
Epicutaneous induction: 50%
Epicutaneous challenge: 25 %
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- olive oil
- Concentration / amount:
- Intradermal induction: 1%
Epicutaneous induction: 50%
Epicutaneous challenge: 25 %
- No. of animals per dose:
- Test group: 10
control groups 1 and 2: 5 - Details on study design:
- RANGE FINDING TEST:
Amount applied: 2 x 2 cm filter paper strips were applied to the skin of the flanks under an occlusive dressing (the bandage consists of rubberized linen patohes 4 x 4 cm from Russka, test patch 5 x 5 cm of Idealbinde from Pfälzische Verbandstoff-Fabrik, and Fixomull Stretch (adhesive fleece) from Beiersdorf AG). The test filter paper strip was soaked in the test substance formulation; thus, the animals were exposed to about 0.15 g of the test substance formulation.
Exposure period: The test substance was applied 2 times for 24 hours within a period of 96 hours in order to detect nonspecific phenomena that are not caused by a sensitization reaction but could possibly be attributed to a shift in the irritation threshold.
Site of application: flank, respective on the same area
Number of test animals: 4 or 8 per test concentration
Readings: about 24 and 48 h after the beginning of application
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous)
- Exposure period: intradermal: unspecified, epicutaneous: 48 hours
- Test group:
Intradermal induction:
A) front row: 2 injections each of 0.1 ml Freund's adjuvant without test substance emulsified with 0.9% aqueous NaCl-solution in a ratio of 1:1
B) middle row: 2 injections each of 0.1 ml of the test substance formulation
C) back row: 2 injections each of 0.1 ml Freund's adjuvant/0.9% aqueous NaCl-solution (1 : 1) with test substance
Epicutaneous induction:
Epicutaneous induction was carried out one week after intradermal induction.
2 x 4 cm filter paper strips were applied to the skin of the shoulder under an occlusive dressing (the bandage consists of rubberized linen patches 4 x 6 cm from Russka and Fixomull Stretch (adhesive fleece) from Beiersdorf AG). The filter paper strip was soaked in the test substance formulation; thus, the animals were exposed to about 0.3 g of the test substance formulation.
- Control groups 1 and 2: The animals were treated analogously to the test group but without test substance.
- Site: shoulder
- Concentrations: intradermal: 1%, epicutaneous: 50%
B. CHALLENGE EXPOSURE (Challenge 21 days after intradermal induction)
- No. of exposures: 1
- Exposure period: 24 hours
- Test group:
2 x 2 cm filter paper strips were applied to the skin of the flank under an occlusive dressing (the bandage consists of rubberized linen patches 4 x 4 cm from Russka, test patch 5 x 5 cm of Idealbinde from Pfälzische Verbandstoff-Fabrik, and Fixomull Stretch (adhesive fleece) from Beiersdorf AG). The test filter paper strip was soaked in the test substance formulation; thus the animals were exposed to about 0.15 g of the test substance formulation. Right flank: 25% test substance in olive oil DAB 10; left flank: olive oil DAB 10
- Control group 1: Right flank: treatment with 25% test substance in olive oil DAB 10, left flank: olive oil DAB 10
- Control group 2: Treatment with olive oil DAB 10 only.
- Site: intact flank
- Concentration: 25%
- Evaluation (hr after challenge): 24 and 48 - Positive control substance(s):
- no
- Remarks:
- A positive control (reliability check) with a known sensitizer is not included in this study. However, the results of the latest study with Alpha-Hexylcinnamaldehyde techn. 85% showed that the test system was able to detect sensitizing compounds.
Results and discussion
- Positive control results:
- A positive control (reliability check) with a known sensitizer was not included in this study. However, the results of the latest positive control study with Alpha-Hexylcinnamaldehyde techn. 85% showed that the test system was able te detect sensitizing compounds under the laboratory conditions chosen.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: control group 1
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: control group 1
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: control group 2
- Dose level:
- vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: control group 2
- Dose level:
- vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 5
Any other information on results incl. tables
After the intradermal induction well-defined erythema and slight edema were observed at the injection sites of control group animals and test group animals at which only Freund's adjuvant / 0.9% aqueous NaCl-solution (1:1) was applied. Injection of a 1% test substance preparation in olive oil DAB 10 or in Freund's adjuvant / 0.9% aqueous NaCl-solution (1:1) caused well-defined erythema and slight edema in the test group animals. The injection sites of the central group animals which were applied with olive oil DAB 10 exhibited well-defined erythema.
After the percutaneous induction with a 50% test substance preparation incrustation, partially open (caused by the intradermal induction) could be observed in addition to well-defined erythema and slight edema in the test group animals.
The animals of control group 1 and 2, which were applied with olive oil DAB 10 showed the same skin reactions as the test group animals.
After the challenge with a 25% test substance preparation no skin reaction could be observed neither in control group 1 nor in the test group.
Olive oil DAB 10, which was applied as a vehicle to all animals did not cause any skin reaction.
The individual body weights can be derived from the respective tables in the Annex.
The evaluation of the results is based on the criteria of the EEC Directive 93/21 for the l8th Amendment of the Directive 67/548 EEC (Publication No. L 110 A, May 4th,1993).
The number of animals sensitized is primarily taken into account in the evaluation. The control animals are used to rule out a substance-induced primary skin irritation.
The findings obtained 24 hours after the removal of the patch are taken into account for the determination of the sensitization rate.
The positive control with Alpha-Hexylcinnamaldehyde techn. 85% showed that the test system was able to detect sensitizing compounds under the laboratory conditions chosen. Based on the results of the study under the test conditions chosen and taking the above cited evaluation criteria into account BPI does not have a sensitizing effect on the skin of the guinea pig in the Maximization Test.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of the study under test conditions chosen, the test substance does not have a sensitizing effect on the skin of the guinea pig in the Maximization Test.
- Executive summary:
The test substance was tested for its sensitizing effect on the skin of the guinea pig in the Maximization Test based on the method of Magnusson and Kligmann and according to OECD 406 and GLP.
The intradermal induction with 1% test substance preparations caused slight to well-deined signs of irritation in the test group animals. After percutaneous induction with a 50% test substance preperation incrustation, partially open (caused by the intradermal induction) could be observed in addition to well-defined erythema and slight edema in the test group animals. No skin reactions were observed after the challenge.
Based on the results of the study under test conditions chosen, the test substance does not have a sensitizing effect on the skin of the guinea pig in the Maximization Test.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.