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EC number: 213-424-8 | CAS number: 947-04-6
- 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
- Study period:
- 1989-04-11 - 1989-05-05
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No positive control (not required by 1981 version of Test Guideline)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1981
- Deviations:
- no
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A skin sensitization test according to OECD 406 has already excisted since 1989 and is sufficient for evaluation of the skin sensitisation potential of the test substance.
Test material
- Reference substance name:
- Dodecane-12-lactam
- EC Number:
- 213-424-8
- EC Name:
- Dodecane-12-lactam
- Cas Number:
- 947-04-6
- Molecular formula:
- C12H23NO
- IUPAC Name:
- 1-azacyclotridecan-2-one
- Test material form:
- solid
- Details on test material:
- Dodecane-12-lactam of Hüls AG, purity approx. 99.9 %; main impurity cyclododecanone approx. 100 ppm
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- - Strain: Dunkin-Hartley (Bor: DHPW)
- Source: F. Winkelmann, Borchen
- Weight at study initiation: test group mean 325 g; control group mean 324 g
- Environmental conditions:
feed: G4 diet for guinea pigs (Ssniff; Soest, Germany);
water: tap water ad libitum;
room temperature: 20°C (+/- 1°C);
humidity: 60% (+/- 5%);
air change: 15 times/hour;
light-dark rhythm: 12 hours light/dark
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- corn oil
- Concentration / amount:
- 1st application: Induction 1 % intracutaneous
2nd application: Induction 25 % occlusive epicutaneous
3rd application: Challenge 25 % occlusive epicutaneous
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- 1st application: Induction 1 % intracutaneous
2nd application: Induction 25 % occlusive epicutaneous
3rd application: Challenge 25 % occlusive epicutaneous
- No. of animals per dose:
- 20 (test) / 9 (control)
- Details on study design:
- ADMINISTRATION/EXPOSURE
- Preparation of test substance for induction: The test substance was ground to a fine powder and dissolved in the vehicle (corn oil) at elevated temperature. After cooling down, the resulting suspension was thoroughly mixed.
- Induction schedule: single intracutaneous treatment, 1 week later dermal induction; slight to medium inflammation caused (10 % SDS in vaseline) before application of patch; patch removed after 48 h
- Challenge schedule: after 2 further weeks, occlusive epicutaneous, removal of patch after 24 h, readings after further 24 and 48 hours.
EXAMINATIONS
- Grading system:
0 % of animals positive: no sensitisation
1 - 8 % of animals positive: very slight sensitisation
9 - 28 % of animals positive: slight sensitisation
29 - 64 % of animals positive: distinct sensitisation
65 - 80 % of animals positive: severe sensitisation
81 -100 % of animals positive: extreme sensitisation - Challenge controls:
- Treatment: vehicle
- Positive control substance(s):
- not required
- Remarks:
- not required by 1981 version of Test Guideline
Results and discussion
- Positive control results:
- not applicable
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25% preparation of test item in corn oil
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- see overall remarks (below)
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25% preparation of test item in corn oil. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: see overall remarks (below).
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25% preparation of test item in corn oil
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- see overall remarks (below)
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25% preparation of test item in corn oil. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: see overall remarks (below).
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this guinea pig maximization test, the test item lauryl lactame showed no dermal sensitization in male guinea pigs.
- Executive summary:
In a guinea pig maximization test performed with the test item lauryl lactame, after intracutane and epidermal inductions and 24 hours as well as 48 hours after epidermal challenge none of the 20 animals examined in this study, showed positive response regarding dermal sensitization.
Under the conditions of this guinea pig maximization test, the test item lauryl lactame showed no dermal sensitization in male guinea pigs.
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