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EC number: 404-360-3 | CAS number: 119313-12-1 CG 25-369; IRGACURE 369; TK 11-319
- 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
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- Nanomaterial pour density
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- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
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- 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:
- 1987-05-04, 1987-06-05
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1981
- Deviations:
- yes
- Remarks:
- The intradermal induction was performed with Freund´s Complete Adjuvant (FCA)/saline (1:1) only. Test article was applied dermal (occlusive) for 24 h. Modifications of the intradermal induction were performed since the test article was not injectable.
- Principles of method if other than guideline:
- Intradermal induction according to guideline requires injection of (1) FCA/saline 1:1, (2) test article at a selected concentration and (3) test article/FCA saline 1:1.
However, in the present study the intradermal induction was performed with Freund´s Complete Adjuvant (FCA)/saline (1:1) only. Subsequently, test article was applied dermal (occlusive) for 24 h.
Modifications of the intradermal induction were done by the author since the test article was not injectable. Validation of this modification with six known sensitisers was published by the author 1998 (Fd. Chem. Toxic. Vol. 27, No. 12, pp. 807-811, 1998). - GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Test was performed in 1987, pre-dating LLNA guideline adoption.
Test material
- Reference substance name:
- 2-benzyl-2-dimethylamino-4'-morpholinobutyrophenone
- EC Number:
- 404-360-3
- EC Name:
- 2-benzyl-2-dimethylamino-4'-morpholinobutyrophenone
- Cas Number:
- 119313-12-1
- Molecular formula:
- C23 H30 N2 O2
- IUPAC Name:
- 2-benzyl-2-(dimethylamino)-1-[4-(morpholin-4-yl)phenyl]butan-1-one
- Details on test material:
- - Substance type: Organic
- Purity: Lab. sample
- Physical state: Solid
- Lot/batch No.: WR 629
- Expiration date of the lot/batch: 1990-02
- Storage condition of test material: Room temperature, in the dark
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Strain as cited in the report: Pirbright White Strain (Tif: DHP)
- Source: CIBA-GEIGY LTD. Tierfarm, 4334 Sisseln, Switzerland
- Age at study initiation: Approx. 10 weeks
- Weight at study initiation: 319 - 424 g
- Housing: Individually in Macrolon cages (Type 3)
- Diet: Ad libitum, standard guinea pig pellets (NAFAG No.846, Gossau SG)
- Water: Ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: FCA/saline 1:1 (intradermal) Petrolatum (epicutanious)
- Concentration / amount:
- 0% test material
0.1 ml - Day(s)/duration:
- Day 1
- Adequacy of induction:
- not specified
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 30 % test material
- Day(s)/duration:
- Day 7 (24 hours)
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 10% test material
- Day(s)/duration:
- Day 22 (48 hours)
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 10 males and 10 females
- Details on study design:
- RANGE FINDING TESTS
Separate animals were treated with test article for evaluation of the primary irritation threshold concentration.
Concentrations of 10 and 30 % of test article in vaseline were tested. Erythema reactions were observed at 30 %. No erythema was induced at the lower concentrations. Therefore, 10 % was used as the maximal subirritant concentration for the challenge application.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
Induction was performed in two steps. First, FCA/saline (1:1) was injected intradermally (0.1 ml) followed by epidermal application of test article in the neck region under occlusive conditions for 24 h. One week later, the second induction was performed by epidermal application under occlusive conditions for 48 h.
- Control group: During the induction period the control group was treated with FCA/saline (1:1) and the vehicle.
- Concentrations: 0.4 g paste of 30 % test article in vaseline.
B. CHALLENGE EXPOSURE
- No. of exposures: 1
Two weeks after epidermal induction the animals were challenged on the flank with test article (0.2 g paste of 10 % test article in vaseline) and the vehicle alone (patch 2 x 2 cm; occluded application for 24 h).
- Control group: The control group was challenged with the vehicle as well as with the test article (at least 10 animals/group) to control the maximal subirritant concentration of the test compound in FCA/saline (1:1) treated animals.
- Evaluation (hr after challenge): 24 and 48 h - Challenge controls:
- 10 control males were challenged with 0.2 g of 10 % test article in vaseline and with vaseline, respectively.
- Positive control substance(s):
- yes
- Remarks:
- The sensitivity of the strain is checked every six months with Paraphenylene-diamine or Potassium-dichromate
Results and discussion
- Positive control results:
- The sensitivity of the strain is checked every six months with Paraphenylene-diamine or Potassium-dichromate.
(s. Th. Maurer, R. Hess, Toxicology 31 (1984) pp. 217-222)
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10 % . No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: None.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 10 % . No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: Vehicle. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: None.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10 % . No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: None.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10 % . No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: Vehicle. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: None.
Any other information on results incl. tables
Number of positive animals per group after occlusive epicutaneous challenge
Control group |
||
Time after challenge |
24 h |
48 h |
Vehicle control |
0/20 |
0/20 |
Test compound |
0/10 |
0/10 |
Test group |
||
Time after challenge |
24 h |
48 h |
Vehicle control |
0/20 |
0/20 |
Test compound |
0/20 |
0/20 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material failed to induce skin sensitisation in the Guinea pig under the conditions of the test. The test material is not considered a skin sensitiser.
- Executive summary:
In this guideline (OECD 406) study conducted to GLP standards, the test material (EC 404-360-3) was determined to be not sensitising to skin. Two groups of 20 male/female guinea pigs were divided into a test group and a control group. For the induction phase FCA/saline (1:1) was injected intradermally (0.1 ml) followed by epidermal application of test article (0.4 g paste of 30 % test article in vaseline) in the neck region under occlusive conditions for 24 h. The control group was treated with FCA/saline (1:1) and vaseline. One week later, the second induction was performed on the test group by epidermal application under occlusive conditions for 48 h.
For the challenge phase, two weeks after epidermal induction the test group animals were challenged on the flank with test article (0.2 g paste of 10 % test article in vaseline) followed by the vehicle alone (occlusive application for 24 h). The control group was challenged with the vehicle as well as with the test article (at least 10 animals/group) to control the maximal subirritant concentration of the test compound in FCA/saline (1:1) treated animals. Both test and control groups were evaluated after 24 and 48 hours. As none of the animals of the test group scored positive for any effects, the test material is not classified as a skin sensitiser under CLP regulation 1272/2008.
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