Dodecane-12-lactam

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1985-01-15 - 1985-01-23

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: In deviation from OECD TG 404 occlusive dressing was used.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1981

Deviations:

yes

Remarks:

occlusive dressing

GLP compliance:

no

Test material

Test material information

Constituent 1

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 > 99.9 %; main impurity cyclododecanone approx. 100 ppm

Test animals

Species:

rabbit

Strain:

other: Small white Russian, Chbb-SPF

Details on test animals or test system and environmental conditions:

- Sex: male and female
- Source: Dr. Karl Thomae GmbH, Biberach
- Weight at study initiation: 2.0-2.5 kg
- Environmental conditions:
room temperature: 20°C (+/- 1°C);
humidity: 60% (+/- 5%);
Air change: 15 times/hour;
Light: 12 hour light/dark rhythm;
feed: K4 complete feed for rabbits (Ssniff, Soest, Germany);
water: tap water ad libitum

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

other: paraffin oil

Controls:

not required

Amount / concentration applied:

0.5 g, ground in mortar, wetted with paraffin oil

Duration of treatment / exposure:

4 hour(s)

Observation period:

- Post exposure observation period: 8 days
- Observations at 1, 24, 48, 72 hours, 6 and 8 days after administration of the test substance

Number of animals:

3 males, 3 females

Details on study design:

- Area of exposure: 6 cm2
- Occlusion: mull patch, polyethylene film, elastic dressing
- Removal of test substance: washing with warm water
- Scoring system: according to Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 1; 24; 48; 72 h

Score:

0.5

Max. score:

8

Reversibility:

fully reversible within: 8 days

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24; 48; 72 h

Score:

0.44

Max. score:

4

Reversibility:

fully reversible within: 8 days

Results 3

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24; 48; 72 h

Score:

0.17

Max. score:

4

Reversibility:

fully reversible within: 8 days

Irritant / corrosive response data:

Only 1/6 animal showed very slight edema (grade 1) at 1 hour. At 24 hours erythema (grades 1 and 2) were seen in 3/6 animals, one animal showed
grade 1 edema. At 48 and 72 hours, still one animal had erythema (grade 2) and edema (grade 1).
AVERAGE SCORE
- Erythema: 0.44
- Edema: 0.17
- Irritation index: 0.5/8)

Other effects:

no further information

Any other information on results incl. tables

no further information

Applicant's summary and conclusion

Conclusions:

According to the study, the test item lauryl lactam showed no irritant effect on the skin of male and female rabbits.

Executive summary:

To test the acute skin irritant effect the test item lauryl lactam was applied to the shaven dorsal skin of rabbits. The product was administered undiluted and the time of exposure in the patch test was 4 hours. According to the study, the test item lauryl lactam showed no irritant effect on the skin of male and female rabbits.