Sodium bis[N-(2-chlorophenyl)-2-[[2-hydroxy-5-(N-methylsulphamoyl)phenyl]azo]-3-oxobutyramidato(2-)]cobaltate(1-)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

31 Jul 1943- 06 August 1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Report date:

1974

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO).

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sodium bis[N-(2-chlorophenyl)-2-[[2-hydroxy-5-(N-methylsulphamoyl)phenyl]azo]-3-oxobutyramidato(2-)]cobaltate(1-)

EC Number:

274-503-0

EC Name:

Sodium bis[N-(2-chlorophenyl)-2-[[2-hydroxy-5-(N-methylsulphamoyl)phenyl]azo]-3-oxobutyramidato(2-)]cobaltate(1-)

Cas Number:

70247-74-4

Molecular formula:

C34H30Cl2CoN8O10S2.Na

IUPAC Name:

sodium bis[N-(2-chlorophenyl)-2-[[2-hydroxy-5-(N-methylsulphamoyl)phenyl]azo]-3-oxobutyramidato(2-)]cobaltate(1-)

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

None

Test animals / tissue source

Species:

rabbit

Strain:

other: Russian breed

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation:1.8 to 2.2 kg
- Housing: kept separately in metal cages (overall dimensions 47x32x34cm)
- Diet: standard diet of Nafag ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 1
- Humidity (%): 55 ± 5
- Photoperiod (hrs dark / hrs light): 14 hours light/day

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g

Duration of treatment / exposure:

1 minute

Observation period (in vivo):

1, 2,3 and 7 days

Number of animals or in vitro replicates:

6 rabbits (3 males and 3 females)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done):The eyes of 3 animals were rinsed 1 minute after application with physiologic saline.

SCORING SYSTEM:
0-10 = minimal
11 - 25 = slight
26 - 55 = moderate
56 - 85 = marked
86 - 110 = extreme

TOOL USED TO ASSESS SCORE: slit lamp

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Remarks:

unrinsed and rinsed eyes

Basis:

mean

Remarks:

6 animal

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

iris score

Remarks:

unrinsed and rinsed eyes

Basis:

mean

Remarks:

6 animal

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Remarks:

unrinsed and rinsed eyes

Basis:

mean

Remarks:

6 animal

Time point:

24 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72 h

Remarks on result:

positive indication of irritation

Results 4

Irritation parameter:

conjunctivae score

Remarks:

unrinsed and rinsed eyes

Basis:

mean

Time point:

48 h

Remarks on result:

not measured/tested

Results 5

Irritation parameter:

conjunctivae score

Remarks:

unrinsed and rinsed eyes

Basis:

mean

Remarks:

6 animal

Time point:

72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

chemosis score

Remarks:

unrinsed and rinsed eyes

Basis:

mean

Remarks:

6 animal

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Other effects:

None

Any other information on results incl. tables

Preparation FAT 20 035/A was found to be practically non irritant when applied to the rabbit eye mucosa. Minimal transient conjunctival reaction was noted 1 and 6 hours following instillation. After 24 hours all findings were negative in 2/3 unrinsed and 1/3 rinsed eyes.

Calculation of the primary eye irritation index

 

time after exposure h	mean reaction score of 3 rabbits
	unrinsed eyes (A)			rinsed eyes (B)
	cornea	iris	conjunctiva	cornea	iris	conjunctiva
6	0	0	4.0	0	0	4.7
24	0	0	2.0	0	0	2.0
72	0	0	0	0	0	0
subtotal	0	0	6.0	0	0	6.7
total	6.0			6.7

 

primary irritation index in unrinsed eyes A = 6.0 :3 = 2.0

primary irritation index in rinsed eyes P. = 6.7 -"3 = 2.2

 

effect of rinsing R = A / B = 2.0 / 2.2 = 0.9

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

FAT 20035/A was found to be practically non irritant when applied to the rabbit eye mucosa.

Executive summary:

A study was performed to determine the eye irritation potential of FAT 20035/A on rabbits. Test method was followed as described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO). The substance was tested on 6 rabbits of the Russian breed. Amounts of 0.l g of the test substance were introduced into the conjunctival sac of the left eye with a spatula . After application, the eyelids were held open for a few seconds. The right eye was left untreated and served as a control. The eyes of 3 animals were rinsed 1 minute after application with physiologic saline. The reactions were appraised with a slit lamp after 1 and 6 hours; 1; 2; 3 and 7 days on the basis of "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the AFDO. Preparation FAT 20035/A was found to be practically non-irritant when applied to the rabbit eye mucosa. Minimal transient conjunctival reaction was noted 1 and 6 hours following instillation. After 24 hours all findings were negative in 2/3 unrinsed and 1/3 rinsed eyes. It can be concluded that FAT 20035/A is practically non irritant when applied to the rabbit eye mucosa.