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EC number: 433-360-6 | CAS number: 34036-80-1
- 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:
- 1999-05-12 to 1999-06-07
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Test method according to EEC, OECD and EPA test guidelines, with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- -
- EC Number:
- 433-360-6
- EC Name:
- -
- Cas Number:
- 34036-80-1
- Molecular formula:
- C18H29N3O3Si
- IUPAC Name:
- 6-{[(butan-2-ylidene)amino]oxy}-3,9-dimethyl-6-phenyl-5,7-dioxa-4,8-diaza-6-silaundeca-3,8-diene
- Reference substance name:
- 2-butanone-O,O',O''- (phenylsilylidyne)trioxime
- IUPAC Name:
- 2-butanone-O,O',O''- (phenylsilylidyne)trioxime
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): OS-9000
- Physical state: Clear liquid
- Analytical purity: >92%
- Lot/batch No.: M-350B
- Expiration date of the lot/batch: 12 February 2000
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: D. Hall, Newchurch, Staffs, UK
- Age at study initiation: Four to seven weeks of age
- Weight at study initiation: 383 - 447 g
- Housing: In groups of five in suspended metal cages with wire mesh floors.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS:
-Temperature: 18 to 26.5ºC
- Humidity: 37 to 64%.
- Photoperiod: 12 hours of artificial light (0700 - 1900 hours GMT).
IN-LIFE DATES: from: May 12 to June 7 1999
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: (acetone in Alebicol D for intradermal injections, and acetone for topical application)
- Concentration / amount:
- Induction intradermal injection - 1% v/v in 5% acetone in Alembicol D
Induction topical application - as supplied
Topical challenge - 50 and 25% v/v in acetone
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: (acetone in Alebicol D for intradermal injections, and acetone for topical application)
- Concentration / amount:
- Induction intradermal injection - 1% v/v in 5% acetone in Alembicol D
Induction topical application - as supplied
Topical challenge - 50 and 25% v/v in acetone
- No. of animals per dose:
- 10 females in the test group.
5 females in the control group. - Details on study design:
- RANGE FINDING TESTS:
The intradermal and topical irritancy of a range of dilutions of the test substance was investigated to determine concentrations that would produce irritation suitable for the induction phase of the main study and the maximum non-irritant concentration by the topical route of administration for the challenge phase. 1% v/v in 5% acetone in Alembic01 D was the highest concentration that caused initation but did not adversely affect the animals. The test substance applied topically as supplied produced some slight irritation but did not adversely affect the animals.
MAIN STUDY
A. INDUCTION EXPOSURE (intradermal and dermal)
- No. of exposures: 1 intradermal (three pairs of injections) and 1 dermal
- Exposure period: - (intradermal), 48 hours (dermal)
- Test groups: Test substance, Test substance + FCA, FCA
- Control group: FCA, FCA + vehicle, vehicle
- Site: A 40 x 60 rnm area of dorsal skin on the scapular region of the guinea-pig was clipped free of hair with electric clippers
- Frequency of applications: Intradermal on day 0, dermal at day 7
- Duration: 7 days
- Concentrations:
Intradermal induction (three pair of injections):
Test substance: 1% v/v in 5% acetone in Alembicol D
Test substance + FCA: 1% v/v in a 50:50 mixture of FCA and 5% acetone in Alembicol D
FCA: diluted with an equual volume of water
Topical induction:
Six days after the injectionshe site was pre-treated by gentle rubbing with 0.5 ml per site of 10% wlw sodium lauryl sulphate in petrolatum. 24 hours
later a 20 x 40 mm patch of paper was saturated with approximately 0.4 test substance as supplied. The patch was placed on the skin of the test animals and covered by a length of impermeable plastic adhesive tape. This 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
- No. of exposures: 1 for each concentration of challenge)
- Day(s) of challenge: 21 (two weeks after induction)
- Exposure period: 24 hours
- Test groups: Test substance
- Control group: Test substance
- Site: Hair was removed by clipping and then shaving from an area on the left flank of each guinea-pig. A 20 x 20 mm patch of paper was saturated with approximately 0.2 ml of test substance 50% v/v in acetone and applied to an anterior site on the flank. 25% v/v of test item in acetone was applied in a similar manner to the posterior site. The patches were sealed to the flank for 24 hours under strips covered by wound round the trunk and secured.
- Concentrations: 50 and 25 % in acetone (see comment below)
- Evaluation (hr after challenge): 24, 48, 72 hours.
OBSERVATIONS:
Clinical signs: All animals were observed daily for signs of ill health or toxicity.
Bodyweight: The bodyweight of each guinea-pig on the main study was recorded on Day 1 (day of intradermal injections) and on the last day observations were made of dermal responses to the challenge application.
Dermal responses: The dermal reactions resulting from intrademl injection and topical application on the preliminary study, and topical application at the challenge were assessed using Draize scoring system.
FCA = Freund's Complete Adjuvant - Challenge controls:
- The control were also challenged topically two weeks after the topical induction application using 50 and 25% v/v of tes item in acetone.
- Positive control substance(s):
- yes
- Remarks:
- (priodically checked by the laboratory)
Results and discussion
- Positive control results:
- The positive controls are periodically checked by Huntingdon Life Sciences to detect skin sensitization potential. The last study was performed between 22 December 1998 and 15 January 1999. In this study HCA produced evidence of skin sensitisation (delayed contact hypersensitivity) in all of the ten animals, thus confirming the sensitivity and reliability of the experimental technique.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1 % intradermal induction
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1 % intradermal induction. No with. + reactions: 4.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1 % intradermal induction
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1 % intradermal induction. No with. + reactions: 6.0. Total no. in groups: 10.0.
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 1 % intradermal induction
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 1 % intradermal induction. No with. + reactions: 6.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 1 % intradermal induction
- 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: 1 % intradermal induction. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 1 % intradermal induction
- 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: 1 % intradermal induction. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 1 % intradermal induction
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 1 % intradermal induction. No with. + reactions: 0.0. Total no. in groups: 5.0.
Any other information on results incl. tables
Clinical signs:
No signs of ill health or toxicity were observed.
Body weight:
Bodyweight increases were recorded for all guinea-pigs over the period of the study.
Induction:
Intradermal injections: Necrosis was recorded at sites receiving FCA in test and control animals. Slight imtation was seen in test animals at sites receiving test item, 1% v/v in 5% acetone in Alembicol D and slight imtation was observed in control animals receiving 5% acetone in Alembicol D.
Topical application: No erythema was observed in test animals following topical application with test item, as supplied. No erythema was seen in the control guinea-pigs.
Challenge:
Dermal reactions were noted in six of the ten test animals compared to none in controls, therefore these six test animals gave positive responses. No reactions were noted for the remaining four animals therefore they gave negative responses.
Dermal reactions observed after the challenge application with test item:
Test substance group:
Animal |
E=Erythema O=Oedema |
Score |
Result |
|||||
24 h |
48 h |
72 h |
||||||
A |
P |
A |
P |
A |
P |
|||
1 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0* |
0 0 |
- |
2 |
E O |
1 1 |
0 0 |
1 1* |
0 0 |
2 1* |
0 0 |
+ |
3 |
E O |
0 0 |
0 0 |
1* 0 |
0 0 |
1 0* |
0 0 |
+ |
4 |
E O |
2 1 |
0 0 |
2 1* |
0 0 |
2 1* |
0 0 |
+ |
5 |
E O |
0 0 |
0 0 |
1 0* |
0 0 |
1 0* |
0 0 |
+ |
6 |
E O |
1 1 |
0 0 |
1 1* |
0 0 |
1 1* |
0 0 |
+ |
7 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
8 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
9 |
E O |
1 1 |
0 0 |
1 0* |
0 0 |
1 0* |
0 0* |
+ |
10 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
* Dryness and sloughmg of the epidermis
A Anterior site, exposed to 0s-9000, 50% v/v in acetone
P Posterior site, exposed to 0s-9000,25% vlv in acetone
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item produced evidence of skin sensitization (delayed contact hypersensitivity) in six of the ten test animals, and therefore the substance isconsidered to have the potential to cause skin sensitization.
- Executive summary:
A guinea pig maximization test was performed to assess the skin sensitization potential of test item using the guinea pig. The method followed was according to EEC method B.6, OECD guideline 406 and EPA OPPS 870.2600. The guinea pigs were dosed by intradennal injection and topical application. Based on the results of a preliminary study and in compliance with the guidelines, the guinea pigs were exposured to intradermal injections of 1% v/v in 5% acetone in Alembicol D, a topical application of the substance as supplied and a challenge application of 50 and 25% vlv in acetone. Ten test and five control guinea pigs were used. In this study, the test substance produced evidence of skin sensitization (delayed contact hypersensitivity) in six of the ten test animals, and therefore, it was considered to have the potential to cause skin sensitization.
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