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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:
1985-11-21 to 1985-11-23
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:
liquid: viscous
Details on test material:
Yellowish liquid, high viscosity
Content: 100%

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: 2.0 - 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

Vehicle:
unchanged (no vehicle)
Controls:
other: identical animals, left eyes remained untreated
Amount / concentration applied:
0.1 mL undiluted test item
Duration of treatment / exposure:
72 hours after application, the treated eyes were rinsed with warm physiological saline
Observation period (in vivo):
- Postexposure observation period: 6 days
- 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:
1.42
Max. score:
110
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24; 48; 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24; 48; 72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
other: 24; 48; 72 h
Score:
0.06
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24; 48; 72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
AVERAGE SCORE
- Cornea: 0
- Iris: 0
- Conjuntivae (Redness): 0.06
- Conjuntivae (Chemosis): 0
- Overall irritation score: 1.42/110
Other effects:
no further information

Any other information on results incl. tables

A slight conjunctiva redness and discharge was observed 1 hour after administration at all animals. At 24 hours after administration only 1 male rabit showed slight conjunctiva redness. At 48 hours all animals were free of signs.

Applicant's summary and conclusion

Conclusions:
According to results of the study, the test item 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 of the test item

2,3-Epoxypropyl neodecanoate, oligomeric reaction products with toluene-4-sulfonic acid

lauryl lactam was administered undiluted into eyes or eyelid sacs of male and female rabbits.

A slight conjunctiva redness and discharge was observed 1 hour after administration at all animals. At 24 hours after administration only 1 male rabit showed slight conjunctiva redness. At 48 hours all animals were free of signs.

According to the study, the test item showed no irritant effect on the eyes and mucosa of male and female rabbits.