Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- 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 406 (Skin Sensitisation)
- Version / remarks:
- (1992)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Species:
- guinea pig
- Strain:
- other: SPF-breeded, strain Hsd/Win:DH
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen/Paderborn, Germany
- Age at study initiation: approx. 5-7 weeeks
- Weight at study initiation: 314-395 g
- Diet and water: ad libitum
- Acclimation period: at least 7 days - Route:
- intradermal and epicutaneous
- Vehicle:
- polyethylene glycol
- Remarks:
- PEG 400
- Concentration / amount:
- concentrations were based on results of range finding tests:
intradermal induction: 5% test substance
epidermal induction: undiluted test substance
first challenge: 12 and 25% test substance
second challenge: 1 and 3% test substance
application volume: 0.5 ml each - Route:
- epicutaneous, occlusive
- Vehicle:
- polyethylene glycol
- Remarks:
- PEG 400
- Concentration / amount:
- concentrations were based on results of range finding tests:
intradermal induction: 5% test substance
epidermal induction: undiluted test substance
first challenge: 12 and 25% test substance
second challenge: 1 and 3% test substance
application volume: 0.5 ml each - No. of animals per dose:
- experimental group: 20
control group: 10 - Details on study design:
- RANGE FINDING TESTS:
- for intradermal induction: 1 guinea pig was intradermally treated with 0.1 ml of 0%, 1%, 2.5% and 5% test substance in PEG 400. 24 and 48 hours later the skin was scored. All treatments led to a whitish area with red border.
- for epidermal induction: 4 guinea pigs were topically treated for 24 hours (occlusive) with 0.5 ml of 12, 25, and 50% test substance in PEG 400 and with the undiluted test substance. The 50% formulation led to slight skin reddening in one animal, the neat test material to slight to moderate skin reddening in all 4 animals.
- for challenge: 5 guinea gigs, primary treated as control animals in the induction phase, were topically treated for 24 hours (occlusive) with 0.5 ml of 6, 12, 25, and 50% test substance in PEG 400. Slight reddening of the skin became obvious only in the 50% group.
OTHER:
In addition to the skin reactions the following data were recorded: Mortality and clinical signs at least once daily; Body weights prior to start and at termination of the study. - Challenge controls:
- Day 1: Animals were intradermally injected similar to the above described protocol with the omission of the test substance; 1 week after intradermal induction: PEG 400 treatment according to the standard procedure; 3 and 4 weeks after intradermal induction: animals were treated epidermally with 0.5 ml with the same test substance concentrations as the treatment groups
- Positive control substance(s):
- yes
- Remarks:
- The sensitivity and reliability of the Maximization Test was routinely proved with the positive substance 2-mercaptobenzothiazole.
- Positive control substance(s):
- mercaptobenzothiazole (CAS No 149-30-4)
- Statistics:
- not applicable
- Positive control results:
- The routine positive control experiments showed the expected results and confirmed the sensitivity and reliability of the test system.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 17
- Total no. in group:
- 20
- Clinical observations:
- no clinical signs
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 17.0. Total no. in groups: 20.0. Clinical observations: no clinical signs.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 12%
- No. with + reactions:
- 13
- Total no. in group:
- 20
- Clinical observations:
- no clinical signs
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 12%. No with. + reactions: 13.0. Total no. in groups: 20.0. Clinical observations: no clinical signs.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 17
- Total no. in group:
- 20
- Clinical observations:
- no clinical signs
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 25%. No with. + reactions: 17.0. Total no. in groups: 20.0. Clinical observations: no clinical signs.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 12%
- No. with + reactions:
- 16
- Total no. in group:
- 20
- Clinical observations:
- no clinical signs
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 12%. No with. + reactions: 16.0. Total no. in groups: 20.0. Clinical observations: no clinical signs.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 3%
- No. with + reactions:
- 11
- Total no. in group:
- 20
- Clinical observations:
- no clinical signs
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 3%. No with. + reactions: 11.0. Total no. in groups: 20.0. Clinical observations: no clinical signs.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no clinical signs
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no clinical signs.
- Reading:
- rechallenge
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 3%
- No. with + reactions:
- 12
- Total no. in group:
- 20
- Clinical observations:
- no clinical signs
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 72.0. Group: test group. Dose level: 3%. No with. + reactions: 12.0. Total no. in groups: 20.0. Clinical observations: no clinical signs.
- Reading:
- rechallenge
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Clinical observations:
- no clinical signs
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 72.0. Group: test group. Dose level: 1%. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: no clinical signs.
- Reading:
- other: 1st and 2nd reading
- Group:
- negative control
- Dose level:
- 25 and 12%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no clinical signs
- Remarks on result:
- other: Reading: other: 1st and 2nd reading. Group: negative control. Dose level: 25 and 12%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no clinical signs.
- Reading:
- other: rechallenge, 48 and 72 hour reading
- Group:
- negative control
- Dose level:
- 3 and 1%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no clinical signs
- Remarks on result:
- other: Reading: other: rechallenge, 48 and 72 hour reading. Group: negative control. Dose level: 3 and 1%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no clinical signs.
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Executive summary:
A skin sensitization test according to OECD guideline 406 (Guinea Pig Maximization Test, GPMT) was conducted on male guinea pigs with test substance concentrations of 5% for intradermal induction (formulated in PEG 400) and 100% for topical induction. Treatment with the neat test material led to bleedings and encrustations in 17 of 20 animals. In one animal this effect appeared to be not reversible during the entire experimental period.
Two challenge experiments were performed. For the first challenge test concentrations of 25 or 12% (in PEG 400) were applied leading to slight to well defined skin reddening and partly squamation in 85% (17 animals) and 80% (16 animals) of the in total 20 animals of the group. After the second challenge treatment with 3 or 1% test substance 60% (12 animals) or 5% (1 animal) exhibited slight skin reddening and/or partly squamation. No skin reactions became evident in the control group after first or second challenge exposure. Thus, under the conditions of this assay the test item has to be regarded as skin sensitizer.
Reference
Induction - test substance group: After the second (topical) induction with the neat test material the treatment area showed bleedings (day 9 after first induction) and subsequent encrustations in 17 of 20 animals. These areas recovered between days 14 to 24. One animal showed skin encrustations up to the end of the experiment.
Induction - control group: The control animals showed no skin reaction after induction treatment.
First challenge - test substance group: After the challenge treatment with 25% or 12% test substance in PEG 400 17 (85%) or 16 (80%) of the in total 20 animals of the group exhibited slight to well defined skin reddening and partly squamation.
Second challenge (rechallenge) - test substance group: After the second challenge treatment with 3 % test substance in PEG 400 12 (60%) animals exhibited slight skin reddening and/or partly squamation. After second challenge treatment with 1% test substance in PEG 400 only 1 animal (5%) reacted with a partly squamation.
First and second challenge - control group: No skin reactions became evident after challenge exposure.
No mortalites, no symptoms of systemic toxicity and no influences on body weight were observed during the study period.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- 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 sensitisation
A skin sensitization test according to OECD guideline 406 (Guinea Pig Maximization Test, GPMT) was conducted on male guinea pigs with the test substance (CAS-No. 179733-18-7) in concentrations of 5% for intradermal induction (formulated in PEG 400) and 100% for topical induction. Treatment with the neat test material led to bleedings and encrustations in 17 of 20 animals. In one animal this effect appeared to be not reversible during the entire experimental period.
Two challenge experiments were performed. For the first challenge test concentrations of 25 or 12% (in PEG 400) were applied leading to slight to well defined skin reddening and partly squamation in 85% (17 animals) and 80% (16 animals) of the in total 20 animals of the group. After the second challenge treatment with 3 or 1% test substance 60% (12 animals) or 5% (1 animal) exhibited slight skin reddening and/or partly squamation. No skin reactions became evident in the control group after first or second challenge exposure. Thus, under the conditions of this assay the test item has to be regarded as skin sensitizer.
Migrated from Short description of key information:
The substance was shown to be a skin sensitizer in the Guinea pig maximization test.
Justification for selection of skin sensitisation endpoint:
only one study available
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the study results the substance should be classified as skin sensitzer Category 1B according to 1272/2008 EC and the 2nd ATP 286/2011 due to a sensitisation response of >= 30% of the animals at an intradermal induction concentration of > 1%.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.