Thiazolidine-2,4-dione

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:

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

Test material information

Constituent 1

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.