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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
The substance should be regarded as a moderate skin irritant and a severe eye irritant.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- 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 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- other: albino rabbits, strain HC:NZW
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Interfauna UK Ltd, Wyton Huntingdon, England
- Diet (e.g. ad libitum): yes
- Water (e.g. ad libitum): yes
- Acclimation period: 2 weeks - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: contralateral untreated skin area of test animals served as control
- Amount / concentration applied:
- Amount: 0.5 ml
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48, 72 hours, 7 and 14 days after application
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: approx. 6 cm²
- Type of wrap if used: Fixomull - stretch Klebeflies, semiocclusive
REMOVAL OF TEST SUBSTANCE
- Washing: treated skin area carefully washed with water without altering the existing response of the integrity of the epidermis
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: mean of 24, 48, 72 hours
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: mean of 24, 48, 72 hours
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: mean of 24, 48, 72 hours
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- other: mean of 24, 48, 72 hours
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- other: mean of 24, 48, 72 hours
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: slight oedema (mean score: 0.3)
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- other: mean of 24, 48, 72 hours
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: slight oedema (mean score: 0.3)
- Irritant / corrosive response data:
- erythematous and exsudative reactions; in 2 animals not proved to be fully reversible within 14 days
mean irritation index calculated by averaging the total scores of all 6 rabbits: erythema and eschar formation (2.02), oedema formation (0.1) - Other effects:
- There were no systemic intolerance reactions recorded.
- Interpretation of results:
- Category 2 (irritant)
- Remarks:
- Migrated information
- Conclusions:
- moderately irrtating to skin
Classification: not irritating - Executive summary:
In a GLP compliant skin irritation study performed according to OECD 404 the test substance was shown to be an irritant to the rabbits skin. No relevant systemic intolerance reactions were observed.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- 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 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- other: albino rabbits, strain HC:NZW
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Interfauna UK Ltd, Wyton Huntingdon, England
- Diet (e.g. ad libitum): yes
- Water (e.g. ad libitum): yes
- Acclimation period: 2 weeks - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: one untreated eye of test animals served as control
- Amount / concentration applied:
- Amount: 0.1 ml
- Duration of treatment / exposure:
- after placing the test substance into the conjunctional sac of the rabbits eye the lids were held together for about one second. 24 hours after treatment the treated eye was rinsed with saline.
- Observation period (in vivo):
- 1, 24, 48, 72 hours and 7, 14, and 21 days post application.
- Number of animals or in vitro replicates:
- 1
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: The eye was rinsed at 24 hours after instillation
SCORING SYSTEM: Draize - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: mean of 24, 48, 72 hours
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- other: area of cornea opacity: more than 3/4 up to complete surface
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: mean of 24, 48, 72 hours
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- other: mean of 24, 48, 72 hours
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: mean of 24, 48, 72 hours
- Score:
- 3.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- other: discharge
- Basis:
- animal #1
- Time point:
- other: mean of 24, 48, 72 hours
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 days
- Other effects:
- There were no systemic intolerance reactions recorded.
- Interpretation of results:
- Category 1 (irreversible effects on the eye)
- Remarks:
- Migrated information
- Conclusions:
- severely irritating to the eye
Classification: not irritating - Executive summary:
In an eye irritation test on rabbits according to OECD 405, the test substance led to marked inflammatory reactions of the corna, iris and conjunctivae in one animal. Discharge was observed. Corneal and conjunctival signs and discharge did not prove to be reversible within 21 days. No systemic intolerance reactions were recorded. Due to animal welfare reasons no further animals were treated. The test substance was shown to induce severely irritating effects to the eye of rabbits.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
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.
Skin irritation:
In a GLP compliant skin irritation study performed according to OECD 404 the test substance (CAS-No. 179733 -18 -7) was shown to be an irritant to the rabbit's skin. No relevant systemic intolerance reactions were observed.
Eye irritation:
In an eye irritation test on rabbits according to OECD 405, the test substance (CAS-No. 179733 -18 -7) led to discharge and marked inflammatory reactions of the corna, iris and conjunctivae in one animal which did not prove to be reversible within 21 days. No systemic intolerance reactions were recorded. Due to animal welfare reasons no further animals were treated. The test substance was shown to induce severely irritating effects to the eye of rabbits.
Respiratory tract irritation:
No data are available for respiratory tract irritation. Inhalation of the gaseous substance is unlikely since the vapour pressure of the substance is very low. In case of aerosol contact an irritating potential to the respiratory tract can be assumed, since the substance is classified as severe eye irritant.
Justification for selection of skin irritation / corrosion endpoint:
only one study available
Justification for selection of eye irritation endpoint:
only one study available
Effects on skin irritation/corrosion: irritating
Effects on eye irritation: highly irritating
Justification for classification or non-classification
Based on the study results the substance should be classified as skin irritant Category 2 and severe eye irritant Category 1 according to Regulation 1272/2008 EC.
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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