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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 245-366-4 | CAS number: 22984-54-9
- 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
Endpoint summary
Administrative data
Description of key information
Skin sensitisation: Key study: A guinea-pig maximisation test conducted with GLP. The substance butan-2-one O,O',O''-(methylsilanetriyl)oxime was determined to be skin sensitizer.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 27 Aug 1985 - 20 Nov 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted 1992
- Deviations:
- yes
- Remarks:
- Only 3 animals in the control group and 15 animals in the test group.
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The test was performed in 1985, i.e. before the entry into force of REACH Regulation.
- Species:
- guinea pig
- Strain:
- other: Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Hazelton Labs, Denver, PA, USA
- Age at study initiation: 5-6 weeks
- Housing: up to 3 per cage
- Diet: standard diet ad libitum
- Water: drinking water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C):22±4
- Humidity (%): 50±15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 1985-08-27 To: 1985-09-26 - Route:
- intradermal and epicutaneous
- Vehicle:
- propylene glycol
- Concentration / amount:
- Induction: intradermal 5%; epicutaneous 25%
- Day(s)/duration:
- single injection (intradermal) and 48h (epicutaneous)
- No.:
- #1
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- propylene glycol
- Concentration / amount:
- 50 %
- No. of animals per dose:
- test: 15
negative control: 3 at challenge - Details on study design:
- RANGE FINDING TESTS: said to have been conducted if necessary, but no details given in the report reviewed. The study schedule does not include a pretest, so it was probably not done.
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous, respectively)
- Exposure period: single injection (intradermal) and 48h (epicutaneous)
- Test groups:
Intradermal (3 pairs of injections; 0.1 ml):
Injection 1: 5% test article in propylene glycol
Injection 2: FCA alone
Injection 3: 5% test article in FCA
Epicutaneous: 0.3 ml: 25% TS in propylene glycol
- Control groups:
Intradermal (3 pairs of injections; 0.1 ml):
Injection 1: vehicle
Injection 2: FCA alone
Injection 3: vehicle in FCA
Epicutaneous: 0.3 ml propylene glycol
- Site: two rows of 3 sites, one row either side of dorsal mid-line
- Frequency of applications: intradermal treatment day 0; topical induction day 7
- Duration: induction period continues to day 21
- Concentrations: intradermal 5%, epicutaneous 25%
B. CHALLENGE EXPOSURE
- No. of exposures: 1 (at two sites: TS and vehicle)
- Day of challenge: day 22
- Exposure period: 24h
- Test groups: 0.2 ml: 50% TS in propylene glycol
- Control groups: 0.2 ml: 50% TS in propylene glycol
- Site: flanks
- Concentrations: 50% - Challenge controls:
- Negative: 6 animals were used at the induction stages. Only 3 were challenged with 50% TS. 3 animals were retained for a possible rechallenge.
Positive: dinitrochlorobenzene; no details are given - Positive control substance(s):
- yes
- Remarks:
- dinitrochlorobenzene
- Positive control results:
- Dinitrochlorobenzene apparently yielded 100% response; no details are given.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 14
- Total no. in group:
- 15
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 14
- Total no. in group:
- 15
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 1
- Total no. in group:
- 3
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 3
- Reading:
- other: No details given
- Group:
- positive control
- Remarks on result:
- other: No details given
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Remarks:
- CLP Implementation.
- Conclusions:
- A guinea-pig maximisation test conducted with GLP but limited in some respects reported a response to challenge (using 50% test substance) in 14 of 15 animals at 24 and 48 h. Responses in 1 of 3 and 0 of 3 were reported at 24 and 48 hours, respectively, in the small negative control group. A response of 30% or more in an adjuvant test indicates sensitisation.
- Executive summary:
A guinea pig maximisation test was conducted in accordance to GLP-standards with a method similar to OECD guideline 406. Fifteen animals were initially (day 0) induced with a 5 % solution of test substance in propylene glycol injected by the intradermal route. A second induction (epicutaneous) was performed on day 7 with the test substance in propylene gylcol at 25 %, the exposure period was 48 hours. The induction period continued to day 21. On day 22 a semiocclusive epicutaneous induction was performed with the test substance in propylene glycol at 50 %. The challenge duration was 24 hours. The negative control group consisted of six animals at induction and three at challenge, three were retained for possible rechallenge. Positive control (dinitrochlorobenzene) was also included in the study design although no details are given.
The test substance caused signs of skin sensisisation in 14 /15 animals, based on the results, the substance was concluded to be a skin sensitizer and is classified in for this hazard in category 1B according to CLP Regulation.
Reference
Table 1: Incidence of dermal response to challenge dosing.
GROUP |
MATERIAL |
INTERVAL |
DERMAL SCORES |
SENSITIZATION INCIDENCE |
|||
|
|
|
0 |
1 |
2 |
3 |
|
Test |
TS 50% |
24h |
1/15 |
1/15 |
4/15 |
9/15 |
14/15 |
|
48h* |
1/15 |
2/15 |
4/15 |
8/15 |
14/15 |
|
|
Vehicle (propylene glycol) |
24h |
0/15 |
0/15 |
0/15 |
0/15 |
0/15 |
|
48h |
0/15 |
0/15 |
0/15 |
0/15 |
0/15 |
|
Vehicle control |
TS 50% |
24h** |
2/3 |
1/3 |
0/3 |
0/3 |
1/3 |
|
48h |
3/3 |
0/3 |
0/3 |
0/3 |
0/3 |
|
|
Vehicle (propylene glycol) |
0/3 |
0/3 |
0/3 |
0/3 |
0/3 |
0/3 |
|
0/3 |
0/3 |
0/3 |
0/3 |
0/3 |
0/3 |
|
Positive control |
Dinitrochlorobenzene (no details given) |
|
|
|
|
|
100% no details given |
Skin reactions were graded:
0 no reaction
1 scattered mild redness
2 moderate and diffuse redness
3 intense redness and swelling
* 5 animals had eschar and 2 had necrosis
**1 animal had eschar
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Skin sensitisation:
Key study: A guinea-pig maximisation test conducted with GLP but limited in some respects reported a response to challenge (using 50% test substance) in 14 of 15 animals at 24 and 48 h. Responses in 1 of 3 and 0 of 3 were reported at 24 and 48 hours, respectively, in the small negative control group. A response of 30% or more in an adjuvant test indicates sensitisation.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available information, the test substance butan-2-one O,O',O''-(methylsilanetriyl)oxime is classified as Sensitiser Category 1B according to CLP Regulation (EC) No 1272/2008 (>30 responding at >1% intradermal induction dose).
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.