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Toxicological information

Skin sensitisation

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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:
1987
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

Constituent 1
Chemical structure
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
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.