Tetrahydrogen [29H,31H-phthalocyanine-2,9,16,23-tetrasulphonato(6-)-N29,N30,N31,N32]cobaltate(4-)

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:

1980

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Section 163.81 of the Regulations for the Enforcement of the Federal Insecticide, Fungicide, and Rodenticide Act (Federal Register, Wednesday, June 25, 1975)

Principles of method if other than guideline:

One-tenth milliliter of the undiluted sample was applied to the right eye of each of nine New Zealand White rabbits from Plummer's Rabbit Ranch. The left eyes were untreated and served as controls.
Corneal, iris, and conjunotival effects are scored

GLP compliance:

no

Remarks:

GLP not mandatory at this date

Test material

Test material information

Constituent 1

Reference substance name:

Tetrahydrogen [29H,31H-phthalocyanine-2,9,16,23-tetrasulphonato(6-)-N29,N30,N31,N32]cobaltate(4-)

EC Number:

238-200-7

EC Name:

Tetrahydrogen [29H,31H-phthalocyanine-2,9,16,23-tetrasulphonato(6-)-N29,N30,N31,N32]cobaltate(4-)

Cas Number:

14285-59-7

Molecular formula:

C32H16CoN8O12S4

IUPAC Name:

tetrahydrogen [29H,31H-phthalocyanine-2,9,16,23-tetrasulphonato(6-)-N29,N30,N31,N32]cobaltate(4-)

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 mL

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 physiological saline.

Observation period (in vivo):

Examinations for gross signs of eye irritation were made at 24, 48, 72 hours, 4 days and 7 days

Number of animals or in vitro replicates:

9

Details on study design:

Nine New Zealand White rabbits were acclimated to the laboratory for at least 7 days prior to being dosed. Twenty-four hours before being dosed, sodium fluorescein {2%) was used in both eyes of each rabbit to assure no corneal opacity was present prior to dosing.
One-tenth milliliter of the undiluted sample was applied to the right eye
of each of nine New Zealand White rabbits. 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 physiological saline. Examinations for gross signs of eye irritation were made at 24, 48, and 72 hours 4 days and 7 days. Sodium fluorescein was used to aid in scoring on the rabbits which had scores of 2 or less in corneal opacity.
Scoring of irritative effects was according to the method of Draize. In which corneal, iris, and conjunotival effects are scored separately

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:

0.89

Max. score:

1

Reversibility:

not specified

Results 2

Irritation parameter:

iris score

Remarks:

Without water rinse

Basis:

mean

Time point:

24/48/72 h

Score:

0.78

Max. score:

1

Reversibility:

not specified

Results 3

Irritation parameter:

conjunctivae score

Remarks:

Without water rinse

Basis:

mean

Time point:

24/48/72 h

Score:

2.15

Max. score:

2.7

Reversibility:

not specified

Results 4

Irritation parameter:

chemosis score

Remarks:

Whitout water rinse

Basis:

mean

Time point:

24/48/72 h

Score:

1.17

Max. score:

2.33

Reversibility:

not specified

Irritant / corrosive response data:

Non Rinsed Eyes :
Irritative effects noted at the 24-hour reading included mild corneal opacity and iritis in all six rabbits, moderate conjunctival erythema in two rabbits severe conjunctival erythema in four rabbits with blisters under the eyelids being noted in two rabbits, mild edema in one rabbit, moderate edema in three rabbits, severe edema in one rabbit, mild discharge in two rabbits, moderate discharge in one rabbit, and severe discharge in one rabbit.
Irritative effects noted at the 72-hour reading included mild corneal opacity in two rabbits, iritis in two rabbits, mild conjunctival erythema in two rabbits, moderate conjunctival erythema in two rabbits and mild edema in two rabbits.
By the seventh day reading no irritative effects were noted in the six rabbits.

Rinsed Eyes :
Irritative effects noted at the 24-hour reading included mild conjunctival erythema in one rabbit, moderate conjunctival erythema in two rabbits with blisters under the eyelids being noted in one rabbit, and mild edema and
discharge in one rabbit. Irritative effects noted at the 72-hour reading were limited to mild conjunctival erythema in one rabbit.
By the seventh day reading no irritative effects were noted in the three rabbits.
No corneal opacity or iritis was noted in any of the rabbits throughout the study.

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

Application of Cobalt Phthalocyanine Tetrasulfonate to the nonrinsed eyes of New Zealand White rabbits produced corneal opacity, iritis, conjunctival erythema, blisters under the eyelids, edema and discharge. These irritative effects reversed within seven days.
Application of Cobalt Phthalocyanine Tetrasulfonate to the rinsed eyes of New Zealand White rabbits produced conjunctival erythema, bisters under the eyelids, edema and discharge. These irritative effects reversed within seven days. No corneal opacity or iritis were noted in any of the rabbits throughout the study.

Under tests conditions, results are considered scientifically valid to be used to support a classification for Eye irritation, Cat 2 according to GHS.