Reaction mass of trientine and trientine, mono- and di-propoxylated

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1971

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted in accordance with guidance but not GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1971

Report date:

1971

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:

not applicable

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of trientine and trientine, mono- and di-propoxylated

EC Number:

942-835-1

Molecular formula:

(C6 H18 N4 . C3 H6 O)x

IUPAC Name:

Reaction mass of trientine and trientine, mono- and di-propoxylated

Test material form:

gas under pressure: refrigerated liquefied gas

Details on test material:

Amounts of 0.1 g. of the test material was introduced into the conjunctival sac of the left eye with a spatula.

Test animals / tissue source

Species:

rabbit

Strain:

other: English Silver

Details on test animals or tissues and environmental conditions:

Rabbits were kept separately in V2A wire cages and fed on NAFAG, Gossau SG, rabbit food and water ad libitum.

Test system

Vehicle:

water

Controls:

yes, concurrent no treatment

Amount / concentration applied:

Amounts of 0.1 g. of the test material was 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 served as a control. The treated eyes of three rabbits were each rinsed with 10 ml. lukewarm water about 30
seconds after treatment.

Duration of treatment / exposure:

7 days

Observation period (in vivo):

Days 1,2,3,4 and 7

Number of animals or in vitro replicates:

Total of six rabbits (3 male and 3 female)

Details on study design:

The procedure adopted was the technique 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 (3 males/3 females) of the English Silver strain, which were kept separately in V2A wire cages and fed on NAFAG, Gossau SG, rabbit food and water ad libitum. Only rabbits showing normal ophthalmic findings were
included in the test.

Amounts of 0.1 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 served as a control. The treated eyes of three rabbits were each rinsed with 10 ml. lukewarm water about 30 seconds after treatment.

The reactions were appraised with a slit-lamp after 24 hours and after 2, 3, 4 and 7 days on the basis of the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the AFDO.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

7 d

Score:

25.5

Max. score:

80

Reversibility:

not specified

Results 2

Irritation parameter:

cornea opacity score

Remarks:

Eyes not rinsed

Basis:

mean

Remarks:

Rabbits 1, 2, and 3 (M)

Time point:

24/48/72 h

Score:

40

Max. score:

80

Reversibility:

not specified

Results 3

Irritation parameter:

cornea opacity score

Remarks:

Eyes rinsed

Basis:

mean

Remarks:

Rabbit 4, 5, 6 (F)

Time point:

24/48/72 h

Score:

20

Max. score:

80

Reversibility:

not specified

Results 4

Irritation parameter:

iris score

Basis:

mean

Time point:

7 d

Score:

0.5

Max. score:

10

Reversibility:

not specified

Results 5

Irritation parameter:

iris score

Remarks:

Eyes not rinsed

Basis:

mean

Remarks:

Rabbit 1, 2 and 3 (M)

Time point:

24/48/72 h

Score:

0.16

Max. score:

10

Reversibility:

not specified

Results 6

Irritation parameter:

iris score

Remarks:

Eyes rinsed

Basis:

mean

Remarks:

Rabbit 4, 5 and 6 (F)

Time point:

24/48/72 h

Score:

0

Max. score:

10

Reversibility:

not specified

Results 7

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

7 d

Score:

14.3

Max. score:

20

Reversibility:

not specified

Results 8

Irritation parameter:

conjunctivae score

Remarks:

Eyes not rinsed

Basis:

mean

Remarks:

Rabbit 1, 2 and 3 (M)

Time point:

24/48/72 h

Score:

18

Max. score:

20

Reversibility:

not specified

Results 9

Irritation parameter:

conjunctivae score

Remarks:

Eyes rinsed

Basis:

mean

Remarks:

Rabbit 4, 5 and 6 (F)

Time point:

24/48/72 h

Score:

14

Max. score:

20

Reversibility:

not specified

Results 10

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Irritant / corrosive response data:

The results of the eye irritation test are summarized in table above. The total maximum is 80 for the cornea, 10 for the iris and 20 for the conjunctivae.
The irritation index was found to be 25.5 for the cornea. 0.5 for the iris and 14.3 for the conjunctivae

Applicant's summary and conclusion

Interpretation of results:

Category 2A (irritating to eyes) based on GHS criteria

Remarks:

Migrated information

Conclusions:

The test material was considered to be a severe irritant to the eyes of rabbits

Executive summary:

Irritation of the test material to the rabbit eye was assessed following 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 (3 males/3 females) of the English Silver strain, which were kept separately in V2A wire cages and fed on NAFAG, Gossau SG, rabbit food and water ad libitum. Only rabbits showing normal ophthalmic findings were included in the test. Amounts of 0.1 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 served as a control. The treated eyes of three rabbits were each rinsed with 10 ml. lukewarm water about 30 seconds after treatment. The reactions were appraised with a slit-lamp after 24 hours and after 2, 3, 4 and 7 days on the basis of the "Appraisal of the Safety

The primary-irritation index, which serves as a measure of the acute irritation provoked by the substance, was found to be 25-5 for the cornea, 0.5 for the iris and 14.3 for the conjunctivae. Thus, the test material is to be considered as a severe irritant (GHS Cat 2a) to the eye of rabbits.