Registration Dossier

Toxicological information

Eye irritation

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Administrative data

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

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 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1981
Deviations:
no
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 ca. 100 ppm

Test animals / tissue source

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

Test system

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

Results and discussion

In vivo

Resultsopen allclose all
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

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 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.