Methyl 4-cyano-5-[[5-cyano-2,6-bis[(3-methoxypropyl)amino]-4-methyl-3-pyridyl]azo]-3-methyl-2-thenoate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Principles of method if other than guideline:

according to Federal Register, Vol. 38, no. 187 (27.09.1973), § 1500.42 and Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, FDA, Austin, Texas 1959, p. 51
The procedure followed the standards of that time.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Methyl 4-cyano-5-[[5-cyano-2,6-bis[(3-methoxypropyl)amino]-4-methyl-3-pyridyl]azo]-3-methyl-2-thenoate

EC Number:

277-146-9

EC Name:

Methyl 4-cyano-5-[[5-cyano-2,6-bis[(3-methoxypropyl)amino]-4-methyl-3-pyridyl]azo]-3-methyl-2-thenoate

Cas Number:

72968-71-9

Molecular formula:

C23H29N7O4S

IUPAC Name:

methyl 4-cyano-5-[[5-cyano-2,6-bis[(3-methoxypropyl)amino]-4-methyl-3-pyridyl]azo]-3-methyl-2-thenoate

Test material form:

solid

Specific details on test material used for the study:

Name of test substance given in the report: Thermoplastrot BS – Misch-Nr. 07-4264
composition of test substance given in the report: 103,0 Teile Thermoplastrot Lm Fw/400 Stück ber. 100%

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

breeder: M. Gaukler, 6050 Offenbach, Germany
mean weight: 2.9 kg

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

amount of test item applied is not given in the report; after treatment the eye was tightly kept close

Observation period (in vivo):

24, 48, and 72 hours

Number of animals or in vitro replicates:

6 animals (1 male, 5 females)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 24 hours

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal: 1, 3, 4, 5, 6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 4

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

not specified

Remarks:

at time point 24h all animals showed score 1.0; at 48h 5 animals showed score 1.0 and one animal showed 2.0; at 72h 4 animals showed score 1.0 and 2 animals showed no effects

Results 5

Irritation parameter:

chemosis score

Basis:

animal: 2, 3, 4, 5

Time point:

24 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 24 hours

Other effects:

slight lacrimation in some animals 24 and 48h after treatment

Applicant's summary and conclusion

Executive summary:

In an eye irritation study performed according to Fed. Reg. 38, no. 187, § 1500.42 (1973) in 1978 the solid test item was applied to the conjunctival sac of one eye of 6 rabbits. The other eye of each animal served as untreated control. The test item led to slight reddening of the conjunctivae in all animals 24 and 48h after treatment and in 4 animals at the time point 72 hours. Slight cornea effects were seen in one animal only at 24 hours and slight chemosis in 4 animals at 24 hours only. In conclusion, the test item led to slight eye irritation in this test.