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EC number: 423-340-5 | CAS number: 162881-26-7 CGI 819
- 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:
- other: Guideline study conducted according to GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- (1992)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Phenyl bis(2,4,6-trimethylbenzoyl)-phosphine oxide
- EC Number:
- 423-340-5
- EC Name:
- Phenyl bis(2,4,6-trimethylbenzoyl)-phosphine oxide
- Cas Number:
- 162881-26-7
- Molecular formula:
- C26 H27 O3 P
- IUPAC Name:
- [phenyl(2,4,6-trimethylbenzoyl)phosphoryl](2,4,6-trimethylphenyl)methanone
- Details on test material:
- - Name of test material (as cited in study report): TKA 40135 (CGI 819)
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: D. Hall, Newchurch, Staffordshire, England
- Age at study initiation: 4 to 5 weeks
- Weight at study initiation: 325-378 g
- Housing: groups of five in suspended metal cages with wire mesh floors
- Diet (e.g. ad libitum): guinea-pig diet FD2 enriched with vitamin C, ad libitum; hay was additionally given weekly
- Water (e.g. ad libitum): drinking water, ad libitum
- Acclimation period: 13 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 29 °C
- Humidity (%): 38 - 64 %
- Air changes (per hr): ca. 15
- Photoperiod (hrs dark / hrs light): 12 hrs / 12 hrs
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: acetone and acetone in Alembicol D
- Concentration / amount:
- Induction, intradermal injection: 1% w/v in 5% acetone in Alembicol D
Induction, topical application: 70% w/v in acetone
Challenge, topical application: 70 and 35% w/v in acetone
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: acetone and acetone in Alembicol D
- Concentration / amount:
- Induction, intradermal injection: 1% w/v in 5% acetone in Alembicol D
Induction, topical application: 70% w/v in acetone
Challenge, topical application: 70 and 35% w/v in acetone
- No. of animals per dose:
- Control animals were 5/group
Test animals were 10/group - Details on study design:
- As the Sponsor advised that the test substance is light sensitive, the test formulations were prepared under safelight and the formulation containers wrapped in aluminium foil. Aluminium foil was incorporated in the dressings to minimise photoinduced degradation ofthe test material. The test substance was prepared prior to each application on the day of dosing in 5% acetone in Alembicol D" (product of coconut oil) and acetone alone.
RANGE FINDING TESTS
The intradermal and topical irritancy of a range of dilutions of the test substance was investigated to identify where possible (a) concentrations of the test substance that would produce irritation suitable for the induction phase of the main study and (b) a maximum non-irritant concentration by the topical route of administration for the challenge phase.
Animals for these investigations were pre-treated with an intradermal injection of Freund's complete adjuvant, 1:1 with water for irrigation, approximately two weeks prior to the start of the preliminary investigations. The concentrations of TKA 40135 (CGI 819) used for the main study were selected based on the results of these preliminary investigations.
MAIN STUDY
A. INDUCTION EXPOSURE
Induction intradermal injections
The control animals were treated similarly to the test animals with the exception that the test substance was omitted from the intradermal injection.
A 40 x 60 mm area of dorsal skin on the scapular region of each test animal was clipped free of hair. Three pairs of intradermal injections were made into a 20 x 40 mm area within the clipped area:
- Freund's complete adjuvant diluted 1:1 with water
- Test material 1%, w/v in 5% acetone in Alembicol D
- Test material 1% w/v in a 1:1 mixture of Freund's complete adjuvant and 5% acetone in Alembicol D
Induction topical application
The control animals were treated similarly to the test animals with the exception that the test substance was omitted from the topical application.
Six days after the injections, the same 40 x 60 mm interscapular area was clipped and shaved free of hair and the site was pre-treated by gentle rubbing with 0.5 ml per site of 10% w/w sodium lauryl
sulphate in petrolatum. After 24 hours, a 20 x 40 mm patch saturated with ca. 0.4 mL of 70% test material in acetone (w/v) was placed on the skin of the test animals and covered by a length of impermeable plastic adhesive tape. This in turn was firmly secured by elastic adhesive bandage wound round the torso of the animal and fixed with impervious plastic adhesive tape. The dressing was left in place for 48 hours.
B. CHALLENGE EXPOSURE
The control and test animals were challenged topically two weeks after the topical induction application; the test concentrations were 70 and 35% w/v in acetone. Hair was removed by clipping and then shaving from an area on the left flank of each animal. A 20 x 20 mm patch was saturated with approximately 0.2 mL of 70% test material in acetone and applied to an anterior site on the flank. The test material at a concentration of 35% in acetone was applied in a similar manner to a posterior site. The patches were sealed to the flank for 24 hours and the dressing was secured as described for the topical induction.
EXAMINATIONS
The dermal reactions were assessed using the following numerical system:
Erythema and eschar formation:
No erythema 0
Slight erythema 1
Well-defined erythema 2
Moderate erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4
Edema formation:
No edema 0
Slight edema 1
Well-defined edema (edges of area well-defined by definite raising) 2
Moderate edema (raised approximately 1 mm) 3
Severe edema (raised more than 1 mm and extending beyond the area of exposure) 4
INTERPRETATION OF RESULTS
Dermal reactions in the test animals elicited by the challenge application were compared with the findings simultaneously obtained in the control animals.
A test animal was considered to show positive evidence of delayed contact hypersensitivity if the observed dermal reaction at challenge was definitely more marked and/or persistent than the maximum reaction seen in animals of the control group.
If the dermal reaction seen in a test animal at challenge was slightly more marked and/or persistent than (but not clearly distinguishable from) the maximum reaction seen in control animals, the result for that test animal was classified as inconclusive.
A test animal was considered to show no evidence of delayed contact hypersensitivity if the dermal reaction resulting from the challenge application was the same as, or less marked and/or persistent than the maximum reaction seen in animals of the control group.
Moreover, all animals were observed daily for signs of ill health or toxicity, and body weight gain was assessed. - Positive control substance(s):
- yes
- Remarks:
- The sensitivity of the guinea-pig strain used is checked periodically at the testing facilities with known sensitisers hexyl cinnamic aldehyde (HCA), Benzocaine and mercaptobenzothiazole (MBT).
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 70% test material in acetone
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Clinical observations:
- No signs of ill health or toxicity were recorded; body weight gain was as expected.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 70% test material in acetone. No with. + reactions: 3.0. Total no. in groups: 10.0. Clinical observations: No signs of ill health or toxicity were recorded; body weight gain was as expected. .
Any other information on results incl. tables
Dermal reactions seen following the induction injections included necrosis at sites receiving Freund's Complete Adjuvant in test and control animals, slight irritation in test animals at sites receiving the test material (% w/v in 5% acetone in Alembicol D), and slight irritation in control animals receiving 5% acetone in Alembicol D.
Induction by topical application resulted in slight erythema in test animals treated with the test material (70% w/v in acetone) as well as slight erythema in the control animals.
After challenge, the dermal reactions seen for three of the ten test animals were more marked than those seen for the controls and, therefore, these animals gave positive responses. A further four animals gave inconclusive responses and the remaining three animals gave negative responses.
Applicant's summary and conclusion
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