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EC number: 457-690-5 | CAS number: 23432-65-7
- 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
OECD 406 (GPMT): not sensitizing
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:
- 03 Nov 2003 - 15 Jan 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted in 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayerisches Landesamt für Arbeitsschutz, Arbeitsmedizin und Sicherheitstechnik, München, Germany
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The test was performed in 2004 when the OECD Guideline 406 adopted in 1992 was the current version. According to this guideline "the Guinea Pig Maximisation Test (GPMT) [...] and the non-adjuvant Buehler Test are given preference over other methods.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, Germany
- Age at study initiation: no data
- Weight at study initiation: 300 - 500 g
- Fasting period before study: no
- Housing: animals were barrier maintained (semi-barrier) in an air-conditioned room, animals were kept in groups in Terluran-cages on Altromin saw fiber bedding
- Diet: Altromin 3122 maintenance diet for guinea pigs (totally pathogen-free, rich in crude fiber), ad libitum
- Water: tap water, ad libitum
- Acclimation period: adequate acclimatisation period
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12 - Route:
- intradermal
- Vehicle:
- corn oil
- Concentration / amount:
- 5%
- Day(s)/duration:
- Day 0
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- Day(s)/duration:
- Day 7 / 48 h
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- Day(s)/duration:
- Day 20 / 24 h
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Range-finding assay: 4
Main test: 5 controls and 10 test animals - Details on study design:
- RANGE FINDING TESTS:
2 animals were intradermally treated with 1%, 2.5%, 5% and 10% of the test item (diluted in corn oil). For the 1% and 2.5% concentration erythema grade 1 were observed 48 h and 72 h after application. For the 5% and 10% concentrations erythema grade 1 and necrosis (5%: 0.2 cm diameter; 10%: 0.3 cm diameter) were observed 48 h and 72 h post-dose, respectively. The concentration of 5% was chosen for intradermal induction.
2 further animals were topically treated with 50% and 100% concentration for 24 and 48 h, respectively. No signs of irritation and systemic toxicity were recorded during the observation time for the animals. Therefore the 100% concentration was chosen for the topical induction as well as for the challenge.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous, respectively)
- Exposure period: single injection (intradermal) and 48 h (epicutaneous)
- Test groups:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture (v/v) FCA/isotonic saline
Injection 2: test substance in corn oil
Injection 3: test substance in a 1:1 mixture (v/v) FCA/isotonic saline
Epicutaneous: test substance (undiluted)
- Control group:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture (v/v) FCA/isotonic saline
Injection 2: Corn oil
Injection 3: Corn oil at 50% (w/v) in a 1:1 mixture (v/v) FCA/isotonic saline
Epicutaneous: Corn oil
- Site: shoulder region (intradermal + epicutaneous)
- Frequency of applications: every 7 days
- Duration: Days 0-9
- Concentrations:
Test item: intradermal 5%, epicutaneous 100%
Control: intradermal 0%, epicutaneous 0%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: day 20
- Exposure period: 24 h
- Test groups: 0.5 mL of the undiluted test item
- Control group: 0.5 mL of the undiluted test item
- Site: left flank (test item), right flank (vehicle)
- Concentrations: 100%
- Evaluation (hr after challenge): 24, 48, and 72 h - Challenge controls:
- The control group is actually a challenge control.
- Positive control substance(s):
- yes
- Remarks:
- Mercaptobenzothiazole
- Positive control results:
- The positive control substance (15% mercaptobenzothiazole in vaseline) induced positive reactions in 8/10 animals (80%), thus meeting the reliability criteria for the GPMT test (≥ 15% positive response). Positive control substances are used periodically as a reliability check (last check before study May 2013) and not during the study itself.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 15%
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Interpretation of results:
- other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008
- Conclusions:
- In a GPMT according to OECD 406 and in compliance with GLP, the test item was not sensitizing. Induction (intradermal: 5%; topical: 100%) and challenge (100%) with the test item revealed no skin reactions in any of the 10 animals. Furthermore no skin reactions were observed in the negative controls (induction with corn oil, topical challenge with 100% test item).
Reference
Induction readings: 3 animals showed erythema (grade 1) after 24 h at injection position 1. 48 h post-dose erythema (grade 1) were observed in 4 animals and necrosis (0.1-0.2 cm diameter; injection position 2) was observed in 6 animals. Erythema (grade 1) were observed in 8/10 animals after injection in position 3. No other signs of irritation were observed after the intradermal application (Induction first stage). No signs of irritation were observed after the topical application (Induction second stage). No signs of irritation and no signs of general toxicity were observed after challenge. Body weights were comparable within the test and control groups and the historical controls.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Skin sensitization
The skin sensitizing properties of methyl-N-{[dimethoxy(methyl)silyl]methyl}carbamate (CAS 23432-65-7) were tested in a study according to OECD TG 406 under GLP conditions using the Guinea pig maximization test (GPMT, BSL, 2004). The GPMT test was performed on 15 female Dunkin Hartley guinea pigs. For the intradermal inductions the initial test item concentration was 5% (v/v) which was the highest concentration to cause mild to moderate skin irritation. A 100% (v/v) formulation of the test item was selected for the epicutaneous induction and the challenge exposure was based on the results of a preliminary irritation study. At the beginning of the induction exposure 10 test animals and 5 control animals were either intradermally treated with 5% of the test substance or vehicle (Day 0), followed by a topical induction (100% or vehicle) under occlusive conditions one week later. On Day 20 all animals were challenged with the test substance at a concentration of 100%. Skin reactions of all animals were evaluated 24 and 48 hours after challenge administration. Challenge exposure with the neat test item revealed no skin reactions in any of the 10 animals. Furthermore no skin reactions were observed in the negative controls. Periodic reliability checks with the positive control (mercaptobenzothiazole) gave the expected results. Therefore, the test substance had no sensitizing potential under the conditions of this test.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The available data on the skin sensitization of the registered substance do not meet the criteria for classification according to Regulation (EC) No 1272/2008, and are therefore conclusive but nor sufficient for classification.
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