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Diss Factsheets

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:
6.6.1994 - 1.7.1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Tetrazolyl-valinesteramid (3-methyl-2-{pentanoyl-[2'-(1H-tetrazol-5-yl)-biphenyl-4-ylmethyl]-amino}-butyric acid benzyl ester)
EC Number:
604-047-3
Cas Number:
137863-20-8
Molecular formula:
C31 H35 N5 O3
IUPAC Name:
Tetrazolyl-valinesteramid (3-methyl-2-{pentanoyl-[2'-(1H-tetrazol-5-yl)-biphenyl-4-ylmethyl]-amino}-butyric acid benzyl ester)

Test animals / tissue source

Species:
rabbit
Strain:
other: Chbb:HM (SPF)
Details on test animals or tissues and environmental conditions:
Rabbits Chbb:HM (SPF) from Dr. K. Thomae GmbH, Biberach (FRO) were used. Animals were utilized only if they were judged healthy on the basis of general
observations and body weight (performed predose).
Animals were assigned to the study using computer-generated random numbers.
Animal identification was by an individual number written with a waterproof marker on the ear.
The animals were acclimatized to laboratory conditions for 8 days. The initial age (at dosing) was 179 to 193 days. The initial weight range (at dosing) was 2145 to
2252 g.
Husbandry
The animals were housed individually in stainless steel cages in an air-conditioned room. The temperature was 20 ± 3 °c, and the relative humidity 30 to 70 %.
Artificial light was provided from 6 a.m. to 6 p.m.
Pelleted standard diet NAFAG No. 814 was freely available (NAFAG, 9202 Gossau, Switzerland). The diet is analyzed for composition and contaminants by the manufacturer and analytical results are archived by the Animal Supply Office CIBA-GEIGY (batches are given in the raw data).
Tap water was freely available. The water is analyzed periodically by lndustrielle Werke Basel (Basel City water supply plant) for compliance with Swiss drinking
water specifications.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: not required, the untreated eye of each animal served as control
Amount / concentration applied:
Application volume: approx. 0.1 g / animal
0.07 g was the maximal amount which could be put into the conjunctiva! sac
The Test Artice! was administered into the conjunctiva! sac of one eye. The contralateral eye was used as control.
Duration of treatment / exposure:
single application
Observation period (in vivo):
72 h
reading time points: 1, 24, 48 and 72 h
Number of animals or in vitro replicates:
3
Details on study design:
Three animals of a pool were selected based on a primary eye examination (24 hrs. before dosing).
0.1 g of the test article was prepared for the application into the conjunctiva! sac of the first animal. 0.07 g was the maximal amount which could be put into the
conjunctiva! sac. After the first assessment of eye reactions in the first animal, the same amount (0.07 g) of compound was then applied to two additional animals.
This stepwize procedure was used to omitt unexpected severe eye reactions in a whole group of 3 animals.
The lids were gently hold together for a second to prevent loss of material.
The test article was administered once.
The administration was performed between 10:00 a.m. and 12:00 a.m ..

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 24 h
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 48h
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 48h
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Other effects:
One and 24 h after application of the test article to the rabbit eyes, only a slight redness of the conjunctivae was observed. The redness was reversible in all animals by 48 h after application of the test article. No other effects were observed. Therefore, the test was finished after 3 days of observation.

Any other information on results incl. tables

Mortality: No mortality was observed.

Clinical Signs: No clinical signs were observed.

Body Weight: No significant compound related effect was observed.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
According to the EC classification criteria PBS 859 DS is classified as nonirritant.