(6R,7R)-7-[((2Z)-2-[({2-[(1,1-dimethylethyl)oxy]-1,1-dimethyl-2-oxoethyl}oxy)imino]-2-{2-[(triphenylmethyl)amino]-1,3-thiazol-4-yl}acetyl)amino]-8-oxo-3-(1-pyridiniumylmethyl)-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

not applicable

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

No guideline is mentioned at the study report, but methodology of an earlier report is mentioned.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

1-{[(6R,7R)-7-[(2Z)-2-({[1-(tert-butoxy)-2-methyl-1-oxopropan-2-yl]oxy}imino)-2-{2-[(triphenylmethyl)amino]-1,3-thiazol-4-yl}acetamido]-2-carboxylato-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-en-3-yl]methyl}pyridin-1-ium

EC Number:

617-560-2

Cas Number:

84377-83-3

Molecular formula:

C45H44O7S2.5/2(C3H7NO)

IUPAC Name:

1-{[(6R,7R)-7-[(2Z)-2-({[1-(tert-butoxy)-2-methyl-1-oxopropan-2-yl]oxy}imino)-2-{2-[(triphenylmethyl)amino]-1,3-thiazol-4-yl}acetamido]-2-carboxylato-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-en-3-yl]methyl}pyridin-1-ium

additive 1

Reference substance name:

N,N-dimethylformamide

EC Number:

200-679-5

EC Name:

N,N-dimethylformamide

Cas Number:

68-12-2

Molecular formula:

C3H7NO

IUPAC Name:

N,N-dimethylformamide

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

The material is an intermediate in the synthesis of ceftazimide and was received from Dr P.C. Nicholson on 8 February 1982. Before use, the material was stored at room temperature and protected from the light.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Not available

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

100 mg material per rabbit

Duration of treatment / exposure:

Not specified

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

Not specified

Details on study design:

Study design and methodology are based on an earlier internal report.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 1 hour

Score:

ca. 7.3

Reversibility:

fully reversible within: 72 hours

Remarks on result:

probability of weak irritation

Results 2

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24 h

Score:

ca. 2

Reversibility:

fully reversible within: 72 hours

Remarks on result:

probability of weak irritation

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

72 h

Score:

ca. 0

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

7 d

Score:

ca. 0

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 1 hour

Score:

ca. 0

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 0

Remarks on result:

no indication of irritation

Results 7

Irritation parameter:

iris score

Basis:

mean

Time point:

7 d

Score:

ca. 0

Remarks on result:

no indication of irritation

Results 8

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 1 hour

Score:

>= 0

Remarks on result:

no indication of irritation

Results 9

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 0

Remarks on result:

no indication of irritation

Results 10

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

7 d

Score:

ca. 0

Remarks on result:

no indication of irritation

Results 11

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Time point:

other: 1 hour

Score:

ca. 7.3

Reversibility:

fully reversible within: 72 hours

Remarks on result:

probability of weak irritation

Results 12

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Time point:

24 h

Score:

ca. 2

Reversibility:

fully reversible within: 72 hours

Remarks on result:

probability of weak irritation

Irritant / corrosive response data:

Slight reaction was observed at 1 hour at conjuctivae. Very slight reaction was observed at 24 hours. No effects were observed on the iris or the cornea.

Any other information on results incl. tables

	Maximum score possible	Mean score at:
		1 hr.	24 hr.	72 hr.	7 days	14 days
Conjunctivae	20	7.3	2.0	0.0	0.0	-
Iris	10	0.0	0.0	0.0	0.0	-
Cornea	80	0.0	0.0	0.0	0.0
OVERALL MEAN SCORE		7.3	2.0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results at one hour, the test material presented a negligible risk of irritancy.

Executive summary:

The substance was tested for acute eye irritancy in New Zealand White rabbits. The results indicated that the material presented a negligible risk of eye irritancy.