Registration Dossier

Administrative data

Description of key information

Dodecane-12-lactam was not sensitizing in a guinea pig maximization test (OECD TG 406, 1981).

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1989-04-11 - 1989-05-05
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No positive control (not required by 1981 version of Test Guideline)
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
1981
Deviations:
no
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
A skin sensitization test according to OECD 406 has already excisted since 1989 and is sufficient for evaluation of the skin sensitisation potential of the test substance.
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male
Details on test animals and environmental conditions:
- Strain: Dunkin-Hartley (Bor: DHPW)
- Source: F. Winkelmann, Borchen
- Weight at study initiation: test group mean 325 g; control group mean 324 g
- Environmental conditions:
feed: G4 diet for guinea pigs (Ssniff; Soest, Germany);
water: tap water ad libitum;
room temperature: 20°C (+/- 1°C);
humidity: 60% (+/- 5%);
air change: 15 times/hour;
light-dark rhythm: 12 hours light/dark
Route:
intradermal and epicutaneous
Vehicle:
corn oil
Concentration / amount:
1st application: Induction 1 % intracutaneous
2nd application: Induction 25 % occlusive epicutaneous
3rd application: Challenge 25 % occlusive epicutaneous
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
1st application: Induction 1 % intracutaneous
2nd application: Induction 25 % occlusive epicutaneous
3rd application: Challenge 25 % occlusive epicutaneous
No. of animals per dose:
20 (test) / 9 (control)
Details on study design:
ADMINISTRATION/EXPOSURE
- Preparation of test substance for induction: The test substance was ground to a fine powder and dissolved in the vehicle (corn oil) at elevated temperature. After cooling down, the resulting suspension was thoroughly mixed.
- Induction schedule: single intracutaneous treatment, 1 week later dermal induction; slight to medium inflammation caused (10 % SDS in vaseline) before application of patch; patch removed after 48 h
- Challenge schedule: after 2 further weeks, occlusive epicutaneous, removal of patch after 24 h, readings after further 24 and 48 hours.
EXAMINATIONS
- Grading system:
0 % of animals positive: no sensitisation
1 - 8 % of animals positive: very slight sensitisation
9 - 28 % of animals positive: slight sensitisation
29 - 64 % of animals positive: distinct sensitisation
65 - 80 % of animals positive: severe sensitisation
81 -100 % of animals positive: extreme sensitisation
Challenge controls:
Treatment: vehicle
Positive control substance(s):
not required
Remarks:
not required by 1981 version of Test Guideline
Positive control results:
not applicable
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
25% preparation of test item in corn oil
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
see overall remarks (below)
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25% preparation of test item in corn oil. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: see overall remarks (below).
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
25% preparation of test item in corn oil
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
see overall remarks (below)
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25% preparation of test item in corn oil. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: see overall remarks (below).
Conclusions:
Under the conditions of this guinea pig maximization test, the test item lauryl lactame showed no dermal sensitization in male guinea pigs.
Executive summary:

In a guinea pig maximization test performed with the test item lauryl lactame, after intracutane and epidermal inductions and 24 hours as well as 48 hours after epidermal challenge none of the 20 animals examined in this study, showed positive response regarding dermal sensitization.

Under the conditions of this guinea pig maximization test, the test item lauryl lactame showed no dermal sensitization in male guinea pigs.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

In a Guinea pig maximization test according to OECD TG 406 (1981), sensitization was not observed in any of 20 animals treated with a 25 % preparation of dodecane-12-lactam in corn oil for both induction and challenge (Hüls AG, 1989).


Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

No information regarding respiratory sensitisation available.


Justification for classification or non-classification

According to the criteria of EC Directive 67/548/EEC and EC Regulation 1272/2008 and based on the results of the studies Dodecane-12-lactam is not classified.