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Diss Factsheets
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EC number: 218-941-2 | CAS number: 2295-31-0
- 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:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data is taken from secondary source
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Report on the testing of ε-caprolactam with respect to possible skin sensitization effects.
- Author:
- National Technical Reports library (NTRL)
- Year:
- 1 987
- Bibliographic source:
- National Technical Reports library (NTRL), FAS DIVISION, Accession number: OTS0514817, Document Control Number: 86870000710, 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned as below
- Principles of method if other than guideline:
- Surface testing of skin sensitization was carried out to study the sensitization potential of ε-caprolactam.
- GLP compliance:
- not specified
- Type of study:
- other: Surface testing for skin sensitization
- Justification for non-LLNA method:
- not specified
Test material
- Reference substance name:
- ε-caprolactam
- EC Number:
- 203-313-2
- EC Name:
- ε-caprolactam
- Cas Number:
- 105-60-2
- Molecular formula:
- C6H11NO
- IUPAC Name:
- Caprolactam
- Test material form:
- solid
- Details on test material:
- - Name of test material (as cited in study report): ε-caprolactam
- Molecular formula (if other than submission substance): C6H11NO
- Molecular weight (if other than submission substance): 113.16 g/mol
- Substance type: Organic
- Physical state: solid
- Purity: no data
- Impurities (identity and concentrations): No data
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): ε-caprolactam
- Molecular formula (if other than submission substance): C6H11NO
- Molecular weight (if other than submission substance): 113.16 g/mol
- Substance type: Organic
- Physical state: solid
- Purity: no data
- Impurities (identity and concentrations): No data
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, open
- Vehicle:
- other: ether
- Concentration / amount:
- 50 %
- Day(s)/duration:
- 14 days
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- epicutaneous, open
- Vehicle:
- other: ether
- Concentration / amount:
- 50%
- Day(s)/duration:
- after a period of 14 days
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- Ten guinea pig and 3 control guinea pig
- Details on study design:
- Details on study design
RANGE FINDING TESTS:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10
- Exposure period: 4 hrs
- Test groups: 10 guinea pig
- Control group: not pretreated
- Site: Left side of guinea pig
- Frequency of applications: 5 times per week
- Duration: 14 days
- Concentrations: 50 %
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: after a period of 14 days
- Exposure period:4 hrs
- Test groups: yes
- Control group: yes
- Site: right side of guinea pig
- Concentrations: 50%
- Evaluation (hr after challenge): 12 hrs
OTHER:
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Hours after challenge:
- 12
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No skin reaction were observed
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
Table: Result
Nr. Of animals |
PREPARATION |
|
SENSITIZATION TESTING |
||||
|
Concentration and number of brushings |
Place of adminis tration |
Result reaction in |
delay |
Concentration and number of brushings |
Place of adminis tration |
Result reaction in |
10 |
50% in ether 10x |
Left side |
10/10 flaky |
14 days |
50% in ether 1x |
Right side |
0/10 |
Control : 3 |
Not pre-treated |
|
50% in ether 1x |
Right side |
0/3 |
Applicant's summary and conclusion
- Interpretation of results:
- other: Not sensitizing
- Conclusions:
- No sensitization could cause on the skin of guinea pigs by repeated application of ε-caprolactam in a50 % solution in ether.
- Executive summary:
Ten guinea were taken and on the left and right sides of each animal, an area of 25 cm2 was shaved.
In induction after 4hrs the left side was cleaned and then it was painted with 50% solution of ε-caprolactam. The brushing was repeated three times , the painting was done each day ( 5 times per week, a total of 10 brushings.
After a period of 14 days, during which time the skin effect on left side was disappeared, both side were shaved again. After 4hrs the right side, which had not been previously treated, was brushed one time crosswise with 50 % .
Control test was carried out on three guinea pigs which had not been previously treated. The skin reaction was observed after 12 hrs of brushing.
No sensitization could cause on the skin of guinea pigs by repeated application of ε-caprolactam in a 50 % solution in ether.
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