Registration Dossier

Toxicological information

Skin irritation / corrosion

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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:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1981
Deviations:
yes
Remarks:
occlusive dressing
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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

Resultsopen allclose all
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
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
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.