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EC number: 227-372-9 | CAS number: 5810-11-7
- 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
Skin sensitisation
Administrative data
- 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: OECD Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- 2-chloro-N,N-dimethyl-3-oxobutyramide
- EC Number:
- 227-372-9
- EC Name:
- 2-chloro-N,N-dimethyl-3-oxobutyramide
- Cas Number:
- 5810-11-7
- Molecular formula:
- C6H10ClNO2
- IUPAC Name:
- 2-chloro-N,N-dimethyl-3-oxobutanamide
- Details on test material:
- Name: Dimetbyl- 2-ch1oroacetoacetamide
Batch No.: 502001
Physical state: clear yellowish liquid
Density: 1.20 g/m3
Storage: ambient, protected from light
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright white Hsd/Poc: DH
- Sex:
- male/female
- Details on test animals and environmental conditions:
- Species: guinea pig
Strain: Pirbright white
Substrain: Hsd/Poc: DH
Source: Harlan-Winkelmann GmbH, Postfach 11 61, Gartenstr.27; D-33178 Borchen
Date of receipt: January 10, 1996 (range finding), January 17, 1996 (main test)
Acclimatization period: 7 days (range finding) 10 days (main test)
Animal selection: random
Animal identification: with colored markings; cage labelled with sex, date of study initiation, project no
Weight range (main test): male: 324 - 387 g, female: 303 - 369 g
Housing: collective housing up to a maximum of 10 animals per cage in a battery of cages, each equipped with a paper roll system
Illurnination: artificial lighting (120 lux) from 7.00 a.m. - 7.00 p.m.
Temperature: 22+/-3 °C
Relative humidity: 30 - 70 %
Measurement: twice daily
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- 5%
Challengeopen allclose all
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- water
- Concentration / amount:
- 5%
- No. of animals per dose:
- 10 males/10 females
- Details on study design:
- The main study was performed on 20 test and 10 control animals. On the basis of the results of the range finding the concentration of 5 % of the test article was considered to be suitable for intradermal injection and the concentration of 100 % for dermal applica-tion.
First stage - an area of 4 x 6 cm over the shoulders was clipped short with electric clip-pers and cleaned with 70 % (v/v) ethanol. Three pairs of intradermal injections were then made symmetrically in two rows on either side of the spine:
Test group:
1. 0.1 ml FCA 50 % (w/w) diluted in aqua ad inject.
2. 0.1 ml test article diluted in aqua ad inject. (final concentration: 5 %)
3. 0.1 ml test article diluted in FCA/aqua ad inject. (final concentration: 5 %)
Control group:
1. 0.1 ml FCA 50 % (w/w) diluted in aqua ad inject.
2. 0.1 ml aqua ad inject.
3. 0.1 ml aqua ad inject. 50 % (w/w) diluted in FCA)
Second stage - 7 days after the intradermal injections, dermal application was initiated. Because the test article was non-irritating at the maximum concentration in the pilot study, the area was reclipped and pretreated with 10 % sodium lauryl sulfate (SLS) in vaseline 24 hours before application of the test article to induce a mild inflammation. The test article (at a concentration of 100 %) was spread in a thick layer [to saturation] over a 4 x 5 cm patch (filter paper). The latter was firmly secured over the previous in-jection sites by an occlusive dressing for 48 h. Control animals received a patch loaded with aqua ad inject.
Challenge procedure
Both control and test animals were subjected to a challenge exposure 14 days after the second stage of induction. The challenge test was performed on a 5 x 5 cm clipped area on each flank of the animals. The maximal non-irritating concentration of the test article (100 %) was applied to the left flank and aqua ad inject. to the right in a volume of 0.5 ml using the patch technique . In each case the duration of exposure was 24 h under an occlusive dressing. 24 and 48 h after patch removal, allergic responses were evaluated on a numerical scale according to Draize.
Rechallenge procedure
Although the contact sensitizing potential of the test article was assessed in the chal-lenge procedure, a rechallenge exposure was initiated 7 days later to confirm the results obtained. The rechallenge procedure was initiated because of the pre-terminal death of guinea pigs and the reaction in one control animal. In both control and test animals, two concentrations of the test article (50 and 25 % in aqua ad iniec!.) were applied to the right flank of each animal in a volume of 0.5 ml each, using the patch technique de-scribed above. Additionally a new control group was treated in the same manner. Ex-treme findings were observed in all guinea pigs of the main test with almost the same intensity of reactions in test and control animals. Slight primary skin reactions were also observed in animals of the new control group.
The severe findings after rechallenge in the animals of the main test confirmed the re-sults obtained after challenge. - Positive control substance(s):
- yes
- Remarks:
- 4-Aminobenzoic acid ethyl ester (benzocaine)
Results and discussion
- Positive control results:
- The reaction to the positive control substance is tested periodically. The last test with 4-Aminobenzoic acid ethyl ester (benzocaine) with an acceptable level of response to this substance was performed in November, 1995.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 19
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 19.0. Total no. in groups: 20.0. Clinical observations: none.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance is sensitizing to the skin under the conditions used.
- Executive summary:
The potential skin sensitizing properties of Dimetbyl-2-chloroacetoacetamide were assessed in the guinea pig maximization test according to OECD Guideline 406 using 20 test and 10 control animals. Following epicutaneous and intradermal induction exposure to the test article or the vehicle, the animals were subjected two weeks later to a challenge exposure with the test article. Allergic responses to the challenge procedure were evaluated 24 and 48 h after the end of the exposure period. 95% of the animals showed an allergic skin reaction.
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