Registration Dossier

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report date:
2000

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
435-680-1
EC Name:
-
Cas Number:
24701-69-7
Molecular formula:
C9H12N2O4S (Hill formula) C9H12N2O4S (CAS formula)
IUPAC Name:
(6R,7R)-7-amino-3-(methoxymethyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Name: 7-AMCA
Chemical name: 7-Amino-3-methoxy-cefalosporanic acid
Molecular formula: C9H12N2O4S
CAS No.: 24701-69-7
Supplier: Sponsor
Batch No.: 36423006
Certificate of analysis: Available
Purity: 90.1 % on anhydrous basis (HPLC)
Water content: 0.3 %
Solubility: In water 0.1 g/L at 20 °C
In methanol 0.05 g/L
Appearance: Yellowish powder
Conditions of storage: Refrigerator, in the dark. Protected from moisture
Stability: Stable over ca. 6 months under conditions of storage. Stable over several weeks at room temperature
Date of expiry: October 2000

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Supplier: Charles River Wiga GmbH, D-97633 Sulzfeld.
Number and sex: 3 females.
Body weight (at the start and at the conclusion of the test): 2.5 to 2.8 kg, respectively 2.6 to 3.1 kg
Animal maintenance:
Hygiene: Optimal hygienic conditions.
Room temperature: average of 20 °C.
Relative humidity: average of 61 %.
Air exchange: 12 per hour.
Light: artificial light from 6 a.m. to 6 p.m.
Cages: individual caging in metal wire cages.
Feed: Altromin 2023 diet for rabbits, ad libitum.
Water: tap water from an automatic watering system, ad libitum.
Acclimatization: 5 to 12 days.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 mL equivalent.
Duration of treatment / exposure:
Test substance instillation
The approximate equivalent of 0.1 mL of the test substance was administered per animal into the conjunctival sacs of the right eyes by gently pulling the lower lids away from the eyeballs for instillation. The eyes were held closed for about one second to prevent a loss of test substance. The weighed amounts of the individual doses were 68, 68 and 66 mg.
The left eyes remained untreated and served as a control.

Observation period (in vivo):
Eye examinations
Both eyes of the animals were examined within 24 hours before the instillation and approximately I, 24, 48 and 72 hours p.a.. The whole eyes, especially the corneae, the irises and the conjunctivae were examined, using an otoscope lamp.
Number of animals or in vitro replicates:
3
Details on study design:
The test substance was dosed first to one animal. As no evidence for a serious damage to the eye of this animal was found until 72 h p.a. (no corrosive effect), the test substance was administered to the other two animals too.

The animals were observed for other than local changes at all observation times too.

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:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.7
Max. score:
1
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.7
Max. score:
1
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 3 days
The untreated eyes were normal at each observation time.
Other effects:
No other local or general findings were noted.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance is not regarded as irritating to eyes.
Executive summary:

The test substance was applied to the intact test eye of each of 3 rabbits. The animals were examined for local reactions and for general signs. Methods and investigations were performed according to the OECD Guideline 405 and the EC method B.5.

Only slight redness was observed in one rabbit at 24 h and 48 h p.a. The test substance is not classified as irritant.