[No public or meaningful name is available]

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: the techniques specified in the Federal Insecticide, Fungicide, and Rodenticide Act (40 CFR 163).

GLP compliance:

no

Remarks:

GLP not mandatory at this date

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of Trihydrogen [29H,31H-phthalocyaninetrisulphonato(5-)-N29,N30,N31,N32]cobaltate(3-) and [29H,31H-phthalocyaninato-N29,N30,N31,N32]cobalt and dihydrogen [29H,31H-phthalocyaninedisulphonato(4-)-N29,N30,N31,N32]cobaltate(2-) and hydrogen [29H,31H-phthalocyaninesulphonato(3-)-N29,N30,N31,N32]cobaltate(1-)

Molecular formula:

C32H16N8Co(SO3)n with n=0 to 3

IUPAC Name:

Reaction mass of Trihydrogen [29H,31H-phthalocyaninetrisulphonato(5-)-N29,N30,N31,N32]cobaltate(3-) and [29H,31H-phthalocyaninato-N29,N30,N31,N32]cobalt and dihydrogen [29H,31H-phthalocyaninedisulphonato(4-)-N29,N30,N31,N32]cobaltate(2-) and hydrogen [29H,31H-phthalocyaninesulphonato(3-)-N29,N30,N31,N32]cobaltate(1-)

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

nine New Zealand White rabbits

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

0.1 g powder.

Duration of treatment / exposure:

The treated eyes of six rabbits were left unrinsed. The treated eyes of three rabbits were rinsed after 30 seconds, for 60 seconds with 200 ml of lukewarm tap water.

Observation period (in vivo):

Examinations for gross signs of eye irritation were made at 24h, 44h20 or 45h20, and 71h30 and 4, 7, 10 and 13 days following application.

Number of animals or in vitro replicates:

9

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Remarks:

Without water rinse

Basis:

mean

Time point:

24/48/72 h

Score:

1.17

Max. score:

1.7

Reversibility:

not specified

Results 2

Irritation parameter:

iris score

Remarks:

Without water rinse

Basis:

mean

Time point:

24/48/72 h

Score:

0.94

Max. score:

1.3

Reversibility:

not specified

Results 3

Irritation parameter:

conjunctivae score

Remarks:

Without water rinse

Basis:

mean

Time point:

24/48/72 h

Score:

2.22

Max. score:

2.33

Reversibility:

not specified

Results 4

Irritation parameter:

chemosis score

Remarks:

Without water rinse

Basis:

mean

Time point:

24/48/72 h

Score:

2.56

Max. score:

4

Reversibility:

not specified

Irritant / corrosive response data:

Non-Rinsed Eyes - Irritative effects noted during the study included mild to extreme corneal opacity with from one-quarter or less up to the entire corneal area involved in all rabbits tested. Mild to severe iritis was observed in all animals, as were conjunctival effects including mild to severe erythema and discharge, and mild to extreme edema. Corneal opacity persisted in three animals through most of the observation period and sporadically after day 4 in the remaining animals. Severe vascularization developed in one animal and small cyst-like growths developed in three others.. Conjunctival effects lasted throughout the observation period in most rabbits. The total irritation scores of this group ranged from 2-90.

Rinsed Eyes - No corneal irritation was observed in the rinsed eye group except slight opacity in one rabbit at 48 hours after dosing. This rabbit also had minor iritis at the 24-hour reading. Conjunctival effects included very slight to severe erythema and very slight edema. Total
irritation scores ranged from 0-9 in this group throughout the observation period.

Many changes persisted for thirteen days after application.

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

Under tests conditions, many changes persisted for thirteen days after application. Therefore, test material is classified as Serious eye damage, Cat 1.