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EC number: 215-892-9 | CAS number: 1445-45-0
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1995-06-19 - 1995-07-06 (experimental phase)
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well-documented GLP OECD guideline study without relevant deviations on the registered substance itself
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Trimethyl orthoacetate
- EC Number:
- 215-892-9
- EC Name:
- Trimethyl orthoacetate
- Cas Number:
- 1445-45-0
- Molecular formula:
- C5H12O3
- IUPAC Name:
- 1,1,1-trimethoxyethane
- Test material form:
- liquid
- Details on test material:
- - Substance type: pure substance
- Storage condition of test material: with exclusion of moisture in a closed vessel in a laboratory hood
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Hsd/Cpb: WU (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Animals were bred by Harlan Winkelmann GmbH, Gartenstrape 27, 33176 Borchen, Germany
- Age at study initiation: not specified
- Weight at study initiation: 200-300 g, the weight of the animal not differing by more than ± 20% from the average for all those of the same sex
- Fasting period before study: not specified
- Housing: conventionally, singly in type III Makrolon cages; Bedding: soft wood fibres of type HW 300/500 W supplied by JELU-Werk, Ludwigsmuhle, 73494 Rosenberg, Germany (the manufacturer provides regular reports on tests for contaminants)
- Diet (e.g. ad libitum): Ssniff R. 10 complete feed for rats supplied by Ssniff, Spezialfutter GmbH, 59494 Soest, Germany. The feed is provided ad libitum. The manufacturer carries out regular analyses of the feed.
- Water (e.g. ad libitum): Drinking water ad libitum, supplied by Gelsenwasser, Wasserwerk, 45721 Haltem, Germany; samples of the tap water are tested in-house each quarter.
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3°C
- Humidity (%): 30 - 70% (brief deviations due to cleaning of the animal room)
- Air changes (per hr): 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12-hour light/dark rhythm (artificial light)
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: an area of the back
- % coverage: 10% of the body surface area
- Type of wrap if used: The treated skin was covered with gauze and the patch was fixed with an elastic dressing.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The dressing was removed 24 hours after administration, and the substance remaining on the skin was wiped off using MEH 56 corn oil.
- Time after start of exposure: 24h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.08 cm3/kg of bodyweight or 2000 mg/kg of bodyweight - Duration of exposure:
- 24h
- Doses:
- 2000 mg/kg b.w.
- No. of animals per sex per dose:
- 5/sex/dose
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were examined for clinical signs 1/2 and 1 hour, 2, 3, 4, 5 and 6 hours after administration, and once a day for the next two weeks. The skin in the area of application was examined for reactions caused by the test substance. The time of occurrence and the nature of the signs were recorded separately for each animal. The bodyweights of the animals were determined on the day of application (day 0), day 7 and at the end of the test (day 14).
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: clinical signs, body weight and gross changes in organs (see above).
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: All animals survived the 14 day observation period.
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: All animals survived the 14 day observation period.
- Mortality:
- No mortality occurred during the observation period.
- Clinical signs:
- other: After a single administration of the test item in a dose of 2000 mg/kg of bodyweight, neither the male nor the female animals showed signs of toxicity or cutaneous reactions in the area of application during the observation period.
- Gross pathology:
- Dissection at the end of the test revealed no evidence of gross changes in organs related to the test substance. In particular, there were no changes in the skin and the subcutaneous tissue in the area of application.
Applicant's summary and conclusion
- Interpretation of results:
- other: EU GHS criteria not met
- Conclusions:
- The study was conducted under GLP according to OECD guideline 402 on the registered substance itself. The method is to be considered scientifically reasonable with no deficiencies in documentation. Hence, the results can be considered as reliable to assess the acute oral toxicity in rats.
Following single application of Trimethyl orthoacetate (TMOA) at a dose of 2000 mg/kg bw, the animals did not show any general clinical signs. No pathological changes on the treated skin of males and females were found. All animals survived the experiment. The bodyweight change was normal for all the test animals. Gross examination did not reveal any pathological changes in the examined animals. So it may be stated that the median lethal dose (LD50) of TMOA is greater than 2000 mg/kg b.w. Since no animal showed at no observation time any pathological changes on the treated skin or other signs of irritation, it may be concluded that, under the conditions of this test, TMOA does not need to be considered as irritating to rat skin.
According to the Regulation (EC) No. 1272/2008, it may be concluded that TMOA is beyond categorization. - Executive summary:
The test for acute dermal toxicity of Trimethyl orthoacetate (TMOA) for rats (according to OECD 402 under GLP) showed, that the liquid test substance led to no mortality in five male and five female animals in a 14 -day limit test with a dose of 2000 mg/kg of bodyweight. No signs of systemic toxicity were observed during the observation period. The test substance was applied dermally (with semiocclusive dressing) in a volume of 2.08 cm3/kg of bodyweight with an exposure time of 24 hours.
None of the male or female animals showed cutaneous reactions in the form of erythema or oedema in the area of application during the observation period.
The changes in bodyweight were normal for all the animals.
Dissection at the end of the test revealed no evidence of gross changes in organs related to the test substance, nor any alterations in subcutaneous tissue or in the area of application.
The limit test for dermal toxicity of TMOA in rats following single application of the test item revealed the following median lethal dose (LD50):
male animals > 2000 mg/kg
female animals > 2000 mg/kg
Accordingly, TMOA is of low toxicity based on the LD50 determined. Since no animal showed at no observation time any pathological changes on the treated skin or other signs of irritation, it may be concluded that, under the conditions of this test, TMOA does not need to be considered as irritating to rat skin. According to Regulation (EC) No 1272/2008, it may be concluded that TMOA is beyond categorization.
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