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EC number: 244-239-0 | CAS number: 21142-29-0
- 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:
- weight of evidence
- Study period:
- 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- An LLNA study was not performed because there is an existing reliable study for skin sensitisation using the Guinea Pig Maximisation test method. Furthermore, the study pre-dates REACH Regulation (EC No 1907/2006) and CLP Regulation (EC No 1272/2008) requirements, which took place in 2007. According to the requirements the first choice in vivo test method for skin sensitisation is the murine local lymph node assay (LLNA).
Test material
- Reference substance name:
- (trimethoxysilyl)methyl methacrylate
- EC Number:
- 611-170-6
- Cas Number:
- 54586-78-6
- IUPAC Name:
- (trimethoxysilyl)methyl methacrylate
- Test material form:
- liquid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, D33178 Borchen
- Weight at study initiation: 300-500g
- Housing: the animals were kept in groups in Terluran cages on Altromin saw fibre bedding, max group size 10 animals
- Diet: Altromin 3122 maintenance diet for guinea pigs, rich in crude fibre, ad libitum
- Water: tap water, ad libitum
- Acclimation period: described as 'adequate'
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/-3
- Humidity (%): 55 +/-10%
- Air changes (per hr): minimum of 10
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- corn oil
- Concentration / amount:
- For the intradermal injection (induction - first stage) the test item was applied at a 2.5% concentration (diluted in corn oil). For the topical application (induction - second stage) the test item was applied at a 100% concentration. For the topical application (challenge) the test item was applied at 100% concentration.
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- For the intradermal injection (induction - first stage) the test item was applied at a 2.5% concentration (diluted in corn oil). For the topical application (induction - second stage) the test item was applied at a 100% concentration. For the topical application (challenge) the test item was applied at 100% concentration.
- No. of animals per dose:
- 10/5 (test/control)
- Details on study design:
- RANGE FINDING TESTS: For the justification of dose levels a preliminary test was performed. Three animals were intradermally treated with 1%, 2.5% and 5% concentration of the test item. For the 1% concentration slight signs of erythema (grade 1) were recorded 24h as well as 48h after application. These symptoms had disappeared 72 h after application. For the 5% concentration erythema grade 1, as well as necrotic formations, was recorded at the 24h, 48h as well as 72 hours reading. For the 2.5% concentration erythema grade 1 was recorded 24h, 48h as well as 72 hours after application.
Therefore, the concentration of 2.5% was chosen for the intradermal induction. Two animals were topically treated with 50% as well as 100% for 24 h and 48 hours 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
FIRST STAGE: INTRADERMAL INJECTION
Three pairs of intradermal injections of 0.1ml volume were given in the shoulder region which was cleared of hair by clipping so that one of each pair lies on each side of the midline.
Test group: Day 0
Injection 1: Freund's Adjuvant complete, 1 + 1 (v/v) diluted with isotonic saline
Injection 2: Prepared test item
Injection 3: Prepared test item at a concentration of 50% (v/v) in Freund's Adjuvant complete, 1+1 (v/v) diluted with isotonic saline
Control group: Day 0
Injection 1: Freund's Adjuvant complete, 1+1 (v/v) diluted with isotonic saline
Injection 2: vehicle
Injection 3: vehicle at a concentration of 50% (v/v) in Freund's Adjuvant complete, 1+1 (v/v) diluted with isotonic saline
Injections 1 and 2 were given close to each other and nearest to the head, while 3 is given toward the caudal part of the test area.
SECOND STAGE: TOPICAL APPLICATION
Test and control group: Day 6
Approximately 24 hrs before the topical induction application the test area, after close clipping, was painted with 0.5ml of 10% sodium lauryl sulphate in vaseline, in order to create a local irritation.
Test group: Day 7
A patch was loaded with 0.5ml of the prepared test item, applied to the test area and held in contact by an occlusive dressing for 48 hours.
Control group: Day 7
A patch was loaded with 0.5ml of the vehicle and applied to the test area and held in contact by an occlusive dressing for 48 hours.
B. CHALLENGE EXPOSURE
TOPICAL APPLICATION
The flanks of treated and control animals were cleared of hair by closely clipping and the use of depilation creme.
Test and control group: Day 20
A patch loaded with 0.5ml of the prepared test item was applied to the left flank of the animals and a patch loaded with 0.5ml vehicle to the right flank (intraspecific control), respectively. The patches were held in contact by an occlusive dressing 24 hours.
OBSERVATION
Test and control group
Approximately 21 hours after removing the patch the challenge area was cleaned and cleared of hair. Approximately 24 hours after removing of the patch the skin reaction was observed and recorded according to the grades shown below. Two more observations were recorded 48 and 72 hours after patch removal. Additionally, all animals have been observed for signs of toxicity at least once daily during the test period. - Positive control substance(s):
- yes
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- 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
- 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:
- positive control
- Dose level:
- 15% Mercaptobenzothiazole
- Remarks on result:
- other: sensitization rate of 70%
Any other information on results incl. tables
In all animals slight signs of erythema were recorded 24 h as well as 48 hours after first application. No other signs of irritation were observed in any of the animals neither after the intradermal application (induction first stage). No signs of irritation were observed after the topical application (induction second stage).
Challenge readings: The results of the test animals at the challenge phase were compared with the results of the control animals. No signs of irritation were observed after the challenge. The maximum percentage of animals sensitized was 0%. Animals of both groups survived throughout the test period. Animals of the test group showed neither reduced weight gain as compared to historical data and the animals of the control group, nor any other signs of toxicity.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material was found not sensitising in a guideline study which was compliant with GLP.
- Executive summary:
Slight signs of erythema were recorded in all animals 24 h and 48 hours after the first application. No other signs of irritation were observed in any other animal neither after the intradermal application (induction first stage), nor after the topical application (induction second stage).
Challenge readings: The results of the test animals at the challenge phase were compared with the results of the control animals. No signs of irritation were observed after the challenge. The maximum percentage of animals sensitized was 0%. Animals of both groups survived throughout the test period. Animals of the test group showed neither reduced weight gain as compared to historical data and the animals of the control group, nor any other signs of toxicity.
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