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Diss Factsheets
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EC number: 282-162-4 | CAS number: 84100-84-5
- 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
Acute oral toxicity: discriminating dose >5000 mg/kg bw; RL2; GLP; No effects were observed at the dose of 3100 mg/kg bw. Animals showed slight clinical signs after 1 day (males) and 2 days (females) of application of the 5000 mg/kg bw dose; all effects fully reversed after 72 hours of application.
Acute dermal toxicity: no study available
Acute inhalation toxicity: no study available
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1988-09-12 to 1988-10-04
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- Official Journal L 251 , 19/09/1984 P. 96
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- OECD 401, adopted 1987-02-24
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- Deviations: no quality assurance implemented for conduct and reporting of test; no analytical test on stability of test substance due to short period between preparation and dosage; deviations do not have an impact on the testing results.
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMA
- Source: WISW (SPF Cqb), Winkelmann, Borchen
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8 weeks (male), 10 weeks (female)
- Weight at study initiation: 165 g (mean; male), 170 g (mean; female)
- Fasting period before study: yes (16 h before and 4 h after application)
- Housing: Makrolon cages (type III), 5 rats per cage
- Diet (e.g. ad libitum): Altromin 1324 pellets
- Water (e.g. ad libitum): tap water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 50 +/- 10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 31%, 50%
- Amount of vehicle (if gavage): 10 mL/kg bw
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw - Doses:
- Two groups with two different doses (3100 mg/kg bw; 5000 mg/kg bw) and 5 males and 5 females per group.
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: several observations at day of application followed by twice a day (once at weekends/bank holidays)
- Necropsy of survivors performed: yes - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 0 %
- Clinical signs:
- other: Slight clinical signs (bad general condition, sedation, bristled fur, increased diuresis) in all males and females of both dose groups from 1st day (males) and 2nd day (females) after application. All clinical signs were observed to be completely reversed
- Gross pathology:
- No pathological anatomical signs were observed in any animal of both dose groups.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The oral LD50 of Trimethylcarbonsäure in male and female rats was >5000 mg/kg bw.
- Executive summary:
In an acute oral toxicity study according to EU Method B.1, as published on 19 September 1984 and equivalent to OECD Guideline 401, two dose groups, each with 5 males and 5 females, fasted, 8 -10 weeks old Wistar strain rats given a single oral dose of Trimethylcarbonsäure in Propylene glycol by gavage at a dose of 3100 mg/kg bw and 5000 mg/kg bw and observed for 14 days.
No animal died during the observation period. Slight clinical signs observed in all animals at first until 3rd day of application included bad general condition, sedation, bristled fur, increased diuresis. All clinical signs completely reversed at end of day 3 after application.
Female rats of both dose groups showed a decrease in growth rate in study week 2.
No pathological anatomical signs were observed in any animal of both dose groups.
Oral LD50 (rat, males/females) > 5000 mg/kg bw
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 5 000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
According to Commission Regulation (EU) 2016/863 of May 2016 acute toxicity testing by the dermal route (Annex VII, point 8.5.3., column 2) ‘does not need to be conducted if the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure.
The registered substance conforms with the requirements given above. Therefore, it can be concluded for acute dermal toxicity that the available information is conclusive for non-classification.
Justification for classification or non-classification
Based on the available relevant and reliable data, the test substance does not need to be classified and labelled according to the CLP Regulation (EC) No 1272/2008 with respect to acute oral toxicity.
No studies are available for acute dermal and acute inhalation toxicity. According to Commission Regulation (EU) 2016/863 of May 2016 acute toxicity testing by the dermal route (Annex VII, point 8.5.3., column 2) ‘does not need to be conducted if the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure'. The registered substance conforms with the requirements given above. Therefore, it can be concluded for acute dermal toxicity that the available information is conclusive for non-classification.
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.
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