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EC number: 201-182-6 | CAS number: 79-16-3
- 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
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Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The original study report was written in the format of a memorandum to W.K. Lowen, dated December 2, 1955, and contained only the conclusions from a series of toxicity studies conducted with 4 chemicals, including the test substance. However, the original report did not contain the individual results of any of the studies. This supplement was written to add the procedures used and the data generated from the skin sensitisation study conducted with the test substance. This supplement to the report was completed March 2, 2010. This study was selected as the key study because the information provided for the hazard endpoint is sufficient for the purpose of classification and labelling and/or risk assessment.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 955
- Report date:
- 1955
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
- Principles of method if other than guideline:
- The study was conducted in guinea pigs to determine the potential for the test substance to elicit a dermal sensitisation reaction. A preliminary skin irritation test in 10 guinea pigs was conducted with a 10 %, 25 %, or 50 % solution of the test substance in water. Based on irritation results, the concentration of 50 % test substance was selected for the induction phase. For the induction phase, one group of 5 guinea pigs received intradermal injection of a 0.1 % solution of test substance in saline on test day 0, 2, 4, 7, 9 and 14. A second group of 5 guinea pigs received a topical application of 50 % test substance in water to an abraded skin site on test day 0, 2, 4, 7, 9, and 14. Evaluation of irritation on the treatment site was conducted at 1, 24 and 48 hours post dosing. On test day 29, animals were challenged with a topical application of 50 % test substance to intact or abraded skin sites. In addition, animals were also challenged with an intradermal injection of 0.1 % test substance in saline. Irritation was evaluated 1, 24, and 48 hours post dosing. Due to ambiguous results from the intradermal administration, the intradermal administration was repeated on test day 35.
- GLP compliance:
- no
- Type of study:
- other: skin sensitisation study
- Justification for non-LLNA method:
- The study was conducted 1955 before LLNA test method was in place (OECD TG 429 was adopted in 2002).
Test material
- Reference substance name:
- N,N-dimethylacetamide
- EC Number:
- 204-826-4
- EC Name:
- N,N-dimethylacetamide
- Cas Number:
- 127-19-5
- Molecular formula:
- C4H9NO
- IUPAC Name:
- N,N-dimethylacetamide
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material: dimethylacetamide (DMAC)
- Physical state: Liquid
- Purity: Purity of the test substance was not measured. However, based on the boiling point and density provided on the sample transmittal documents dated October 12, 1950 (165 ºC, and 0.9366 g/cm³ at 25ºC), the test substance appears to be consistent with technical grade (boiling point 164-166 ºC, and 0.94 g/cm³, respectively).
No further details available.
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- No details available.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: saline
- Concentration / amount:
- 0.1%
- Day(s)/duration:
- 0, 2, 4, 7, 9, 14
- Route:
- other: epicutaneous, abraded skin
- Vehicle:
- water
- Concentration / amount:
- 50%
- Day(s)/duration:
- 0, 2, 4, 7, 9, 14
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challengeopen allclose all
- No.:
- #1
- Route:
- other: Intradermal injection and topical administration (intact or abraded skin, 2 groups).
- Vehicle:
- other: saline (injection), water (topical)
- Concentration / amount:
- 0.1% (injection), 50% (topical)
- Day(s)/duration:
- 29
- No.:
- #2
- Route:
- intradermal
- Vehicle:
- other:
- Concentration / amount:
- Rechallenge: 0.1% in saline
- Day(s)/duration:
- 35
- No. of animals per dose:
- - Induction: 5 animals (intradermal injection dosing method); 5 animals (scratch dosing method)
- Challenge: 7 animals (topical dosing method), 3 of these animals (scratch dosing method) and 4 animals (intradermal injection dosing method)*
* Loss of 3 animals to epidemic of dysentery. - Details on study design:
- RANGE FINDING TESTS: A preliminary skin irritation test in 10 guinea pigs was conducted with a 10, 25, or 50 % solution of the test substance in water, applied topically to 3 separate locations on each guinea pig. Irritation was reported at all 3 concentrations 1 hour following application. At 24 hours, irritation was only observed on the sites treated with the 50 % solution. Based on the irritation results following topical application of 50 % test substance, this concentration was selected for the induction phase.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 6
- Test groups: Intradermal injection (5 animals); scratch (5 animals)
- Frequency of applications: test days 0, 2, 4, 7, 9, 14
- Concentrations: 0.1 % solution of test substance in saline (intradermal); 50 % solution of test substance in water (scratch)
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: test day 29
- Test groups: Topical (all 7 animals); intradermal (4 of the 7 animals); scratch (3 of the 7 animals)
- Concentrations: 50 % solution of test substance in water (topical); 0.1 % solution of test substance in saline (intradermal); 50 % solution of test substance in water (scratch)
- Evaluation (after challenge): 1, 24 and 48 hours post dosing
OTHER:
-Rechallenge: On test day 35, the animals previously challenged with an intradermal injection, received an additional injection as described above, and the injection sites were evaluated at 1, 24, and 48 hours post dosing. The second intradermal injection was conducted to clarify the results of the previous injection.
- Body weights were recorded initially and after induction and challenge phases. - Challenge controls:
- No data
- Positive control substance(s):
- not specified
Results and discussion
- Positive control results:
- No data
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 1
- Group:
- other: Topical test group
- Dose level:
- 50 % test substance solution
- No. with + reactions:
- 7
- Total no. in group:
- 7
- Reading:
- 1st reading
- Hours after challenge:
- 1
- Group:
- other: Topical test group w/Scratch application
- Dose level:
- 50 % test substance solution
- No. with + reactions:
- 3
- Total no. in group:
- 3
- Reading:
- 1st reading
- Hours after challenge:
- 1
- Group:
- other: Topical test group w/Intradermal application
- Dose level:
- 0.1 % test substance solution
- No. with + reactions:
- 3
- Total no. in group:
- 4
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- other: Topical test group
- Dose level:
- 50 % test substance solution
- No. with + reactions:
- 1
- Total no. in group:
- 7
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- other: Topical test group w/Scratch application
- Dose level:
- 50 % test substance solution
- No. with + reactions:
- 1
- Total no. in group:
- 3
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- other: Topical test group w/Intradermal application
- Dose level:
- 0.1 % test substance solution
- No. with + reactions:
- 4
- Total no. in group:
- 4
- Reading:
- other: 3rd reading
- Hours after challenge:
- 48
- Group:
- other: Topical test group
- Dose level:
- 50 % test substance solution
- No. with + reactions:
- 0
- Total no. in group:
- 7
- Reading:
- other: 3rd reading
- Hours after challenge:
- 48
- Group:
- other: Topical test group w/Scratch application
- Dose level:
- 50 % test substance solution
- No. with + reactions:
- 0
- Total no. in group:
- 3
- Reading:
- other: 3rd reading
- Hours after challenge:
- 48
- Group:
- other: Topical test group w/Intradermal application
- Dose level:
- 0.1 % test substance solution
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Reading:
- rechallenge
- Hours after challenge:
- 1
- Group:
- other: Test group challenged with second Intradermal injection
- Dose level:
- 0.1 % test substance solution
- No. with + reactions:
- 3
- Total no. in group:
- 4
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- other: Test group challenged with second Intradermal injection
- Dose level:
- 0.1 % test substance solution
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- other: Test group challenged with second Intradermal injection
- Dose level:
- 0.1 % test substance solution
- No. with + reactions:
- 0
- Total no. in group:
- 4
Any other information on results incl. tables
Body weights measured after induction and challenge demonstrated that the animals were growing normally. For the induction phase, one group of 5 guinea pigs received an intradermal injection (0.1 mL) of a 0.1% solution of test substance in saline on test day 0, 2, 4, 7,9, and 14. A second group of 5 guinea pigs received a topical application of 50 % test substance in water to an abraded skin site on test day 0, 2, 4, 7, 9, and 14. Evaluation of irritation on the treatment site was conducted a 1, 24 and 48 hours post dosing. Irritation was observed at 1 and 24 hours following either intradermal injection of 0.1 % or topical application of 50 % test substance to an abraded skin site. Irritation was not observed at 48 hours post dosing. On test day 29, animals were challenged with a topical application of 50 % test substance to an intact or abraded skin site. In addition, animals were also challenged with an intradermal injection of 0.1 % test substance. Irritation was evaluated 1, 24, and 48 hours post dosing. Intradermal administration was repeated on test day 35. Irritation was observed following a topical challenge application to intact or abraded skin; and following the intradermal challenge application at 1 hour and 24 hours post dosing. No irritation was observed at 48 hours post dosing. Based on the similarity of the irritation response following induction applications, the irritation response observed following the challenge phase was not considered to be consistent with a sensitising response. The test substance was not considered to be a sensitizer. The study and the conclusions which are drawn from it fulfil the quality criteria (validity, reliability, repeatability).
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study, the test substance was not considered to be a skin sensitiser.
- Executive summary:
A study was conducted in guinea pigs to determine the potential for the test substance DMAC, CAS 127 -19 -5 to elicit a dermal sensitisation reaction.
A preliminary skin irritation test in 10 guinea pigs was conducted with a 10, 25, or 50 % solution of the test substance in water, applied topically to 3 separate locations on each guinea pig. Irritation was reported at all 3 concentrations 1 hour following application. At 24 hours, irritation was only observed on the sites treated with the 50 % solution. Based on the irritation results following topical application of 50 % test substance, this concentration was selected for the induction phase.
For the induction phase, one group of 5 guinea pigs received an intradermal injection (0.1 mL) of a 0.1% solution of test substance in saline on test day 0, 2, 4, 7,9, and 14. A second group of 5 guinea pigs received a topical application of 50 % test substance in water to an abraded skin site on test days 0, 2, 4, 7, 9, and 14. Evaluation of irritation on the treatment site was conducted a 1, 24 and 48 hours post dosing. Irritation was observed at 1 and 24 hours following either intradermal injection of 0.1 % or topical application of 50 % test substance to an abraded skin site. Irritation was not observed at 48 hours post dosing.
On test day 29, animals were challenged with a topical application of 50 % test substance to intact or abraded skin sites. In addition, animals were also challenged with an intradermal injection of 0.1 % test substance. Irritation was evaluated 1, 24, and 48 hours post dosing. Intradermal administration was repeated on test day 35. Irritation was observed following a topical challenge application to intact or abraded skin; and following the intradermal challenge application at 1 hour and 24 hours post dosing. No irritation was observed at 48 hours post dosing. Based on the similarity of the irritation response following induction applications, the irritation response observed following the challenge phase was not considered to be consistent with a sensitising response. Under the conditions of this study, the test substance was not considered to be a skin sensitiser.
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