Registration Dossier

Administrative data

Description of key information

Dodecane-12-lactam was not irritating to the rabbit skin or eye (OECD TG 404, 405). 

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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.
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1981
Deviations:
yes
Remarks:
occlusive dressing
GLP compliance:
no
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
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
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
no further information
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1985-01-15 - 1985-01-21
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1981
Deviations:
no
GLP compliance:
no
Species:
rabbit
Strain:
other: Small white Russian, Chbb-SPF
Details on test animals or tissues and environmental conditions:
- Sex: male and female
- Source: Dr. Karl Thomae GmbH, Biberach
- Weight at study initiation: 2.1-2.4 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
Vehicle:
unchanged (no vehicle)
Controls:
other: identical animals, left eyes remained untreated
Amount / concentration applied:
0.1 gram, finely ground in a mortar, undiluted
Duration of treatment / exposure:
not rinsed - no removal of test substance
Observation period (in vivo):
- Postexposure observation period: 3 weeks
- Ophtalmoscopic examination: 1, 24, 48, 72 hours, 6 days after treatment
Number of animals or in vitro replicates:
3 males, 3 females
Details on study design:
- Tool used to assess score: Na fluorescein / ophthalmic lamp / visual inspections
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1; 24; 48; 72 h
Score:
7.17
Max. score:
110
Reversibility:
fully reversible within: 6 days
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24; 48; 72 h
Score:
0.11
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24; 48; 72 h
Score:
0.28
Max. score:
2
Reversibility:
fully reversible within: 48h
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
other: 24; 48; 72 h
Score:
1.17
Max. score:
3
Reversibility:
fully reversible within: 6 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24; 48; 72 h
Score:
0.56
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritant / corrosive response data:
A slight corneal opacity was noted in one female at 24 hrs, that diminished in severity at 48 hrs already, and was completely reversible at 72 hours. 5/6 animals showed a slight reddening of parts of the iris at 24 hours; this effect was completely resolved at 48 hours. Very slight to slight conjunctival redness started at 1 hour after instillation, and was most prominent at 24 hours (grades 1-3 for redness, 0-2 for swelling), diminished in severity by 48 hours (grades 0-2 for redness, 0-1 for swelling) and was only seen in 2/6 animals at 72 hours (grade 1 redness, no swelling). Conjunctival effects were completely reversible within 6 days.
AVERAGE SCORE
- Cornea: 0.11
- Iris: 0.28
- Conjuntivae (Redness): 1.17
- Conjuntivae (Chemosis): 0.56
- Overall irritation score: 7.17/110
Other effects:
no further information
no further information
Conclusions:
According to the study, the test item lauryl lactam showed no irritant effect on the eyes and mucosa of male and female rabbits.
Executive summary:

To test the acute irritant effect on eyes and mucosa the test item lauryl lactam was administered undiluted into eyes or eyelid sacs of male and female rabbits. According to the study, the test item lauryl lactam showed no irritant effect on the eyes and mucosa of male and female rabbits.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin Irritation

Studies in Animals

In a study performed according to OECD TG 404 under occlusive conditions, the chemical (moistened with paraffin oil) caused only very mild and transient effects on rabbit skin with average Draize scores of 0.44 for erythema and 0.17 for edema. Based on these results, dodecane-12-lactam cannot be considered as a skin irritant (Hüls AG, 1985). Another study (Centre de Recherche et d'Elevage des Oncins, 1975) came to the same result that the test item Lauryl lactam showed no irritant effect on the skin of male and female rabbits.

 

Eye Irritation

Studies in Animals

In an eye irritation study in rabbits following OECD TG 405, neat dodecane-12-lactam elicited only slight conjunctival effects that were most prominent at 48 hours after instillation and completely resolved within 6 days (average Draize scores 1.17 for redness and 0.56 for chemosis). 5 out of 6 animals showed a slight reddening of parts of the iris at 24 hours; this effect had completely subsided at 48 hours. Based on these results, dodecane-12-lactam cannot be considered as an eye irritant (Hüls AG, 1985). Another study (Centre de Recherche et d'Elevage des Oncins, 1975) showed the same result that the test item Lauryl lactam has no irritant properties on eyes and mucosa.

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.