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EC number: 613-645-3 | CAS number: 646505-36-4
- 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
LD50 oral: > 2000 mg/kg bw
LD50 dermal: > 2000 mg/kg bw
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: comparable to guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: Richtlinie 84/449/EWG, test protocol corresponds to OECD 401, Limit Test
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan-Winkelmann, Borchen, Germany
- Acclimation period: at least 5 days
- Age at study initiation: males appr. 7-8 weeks, females appr. 9-10 weeks
- Fasting period before treatment: 16 hours
- Fasting period after treatment: 4 hours
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum - Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Remarks:
- PEG 400
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: no data
- Volume of application: 10 ml/kg bw
The test substance was - Doses:
- 2000 mg/kg bw
- 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: twice daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- limit test, no statistics required
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: clinical signs: temporarily increased salivation and breathing sounds which disappeared up to day 3 after treatment
- Mortality:
- none; one male died immediately after dosing as a consequence of misapplication of the test substance
- Clinical signs:
- other: temporarily increased salivation and breathing sounds which disappeared up to day 3 after treatment
- Gross pathology:
- no unusual lesions were noted; yellowish liquid was observed in the male which was died by misapplication
- Executive summary:
The acute oral toxicity of the test item was evaluated in a GLP-compliant study on male and female Wistar rats. The acute oral LD50 was determined with > 2000 mg/kg bw. As clinical signs temporarily increased salivation and breathing sounds were observed which disappeared up to day 3 after treatment.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The study is GLP compliant and has Klimisch score 1.
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- (1987)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Strain: HsdCpb: Wu
- Source: Harlan GmbH, 5960 AD Horst, Netherlands
- Age at study initiation: approximately 9-13 weeks
- Diet and water: ad libitum
- Acclimation period: at least 5 days - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
One day before the start of the treatment the back and flanks of the rats were shorn (approximately 10 % of the body surface area). For each dose and animal the required amount of the pure liquid test substance was calculated on the base of the body weight at time of dosing. This amount was weighed and applied as uniformly and thinly as possible to the test area, covered with a gauze-layer (6.0 cm x 5.0 cm = 30.0 cm²) of a "Cutiplast steril" coated with "Leukoflex". The gauze strip was placed on the rat's back and secured with a "Lomir biomedical Inc rat jacket", which was connected with a safety pin to the stretch tape to ensure that the animals could not ingest the test substance.
REMOVAL OF TEST SUBSTANCE
After approximately 24 hours the dressings were removed and the area was rinsed with tepid water using soap and gently patting the area dry. - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw per 30.0 cm²
Dose range: males 18.9 - 19.5 mg/cm²; females 14.6 - 15.7 mg/cm². - No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: at least 14 days
- Frequency of observations and weighing: Clinical signs and mortality rates were determined several times on the day of application and subsequently at least once daily. The weight gain of the animals was checked weekly until the end of the study.
- Necropsy of survivors performed: yes - Statistics:
- none; limit dose study; judgement according to the Globally Harmonization System (GHS) in analogy with the OECD Draft Guideline 434.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no clinical signs, no effects on weight development and no gross pathological findings; local effects: partial reddening of the treatment area in one male and one female
- Mortality:
- No mortalities occured.
- Clinical signs:
- other: No clinical signs were observed.
- Gross pathology:
- The necropsies performed at the end of the study revealed no particular findings.
- Other findings:
- partial reddening of the treatment area in one male (day 2) and one female (day 2-3) animal
- Executive summary:
An acute dermal toxicity study (limit test) was performed on male and female rats according to OECD TG 402. No mortalities, clinical signs, effects on body weight or gross pathological findings were observed during the 14 -day observation period. Local effects became obvious as partial reddening of the skin in one male and one female rat. The resulting dermal LD50 was > 2000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The study is GLP compliant and has Klimisch score 1.
Additional information
Desmorapid 01 can be chemically described as ‘butanoic acid, 3-oxo-, methylester, reaction products with N,N-dimethyl-1,3-propanediamine and propylene glycol ether with trimethylol propane (3:1) (CAS-No. 646505-36-4)’ or (different description of the same substance) ‘poly [oxy(methyl-1,2-ethanediyl)] , a -hydro-w -hydroxy-, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1), 3-[[3-dimethylamino) propyl]imino]butanoate’ (CAS-No. 857285-61-1). The closely related CAS-No. 179733-18-7 describes the same substance and differs only in the manufacturing process where ethanol is distilled off while for the other two CAS-Nos. methanol is distilled off (see IUCLID section 1.1). Thus, toxicological data for all three CAS-Nos. are considered relevant for the substance to be registered and are taken into account for human health assessment.
Acute oral toxicity
The acute oral toxicity of the test item (CAS-No. 179733 -18 -7) was evaluated in a GLP-compliant study on male and female Wistar rats. The acute oral LD50 was determined with > 2000 mg/kg bw. As clinical signs temporarily increased salivation and breathing sounds were observed which disappeared up to day 3 after treatment.
Acute dermal toxicity
An acute dermal toxicity study (limit test) was performed on male and female rats according to OECD TG 402 with the test item (CAS-No. 646505 -36 -4). No mortalities, clinical signs, effects on body weight or gross pathological findings were observed during the 14 -day observation period. Local effects became obvious as partial reddening of the skin in one male and one female rat. The resulting dermal LD50 was > 2000 mg/kg bw.
Acute inhalation toxicity
Acute inhalation toxicity studies are not available for the substance.
Justification for selection of acute toxicity – oral endpoint
only one study available
Justification for selection of acute toxicity – dermal endpoint
only one study available
Justification for classification or non-classification
The acute oral and dermal toxicity was proven to be low with LD50 values of > 2000 mg/kg. Thus, no classification with regard to acute oral and dermal toxicity is required.
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