Potassium hydrogen -5-amino-4-hydroxybenzene-1,3-disulphonate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Remarks:

according to OECD 405, limitied documentation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Version / remarks:

Directive 84/449/EEC

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Potassium hydrogen -5-amino-4-hydroxybenzene-1,3-disulphonate

EC Number:

280-719-6

EC Name:

Potassium hydrogen -5-amino-4-hydroxybenzene-1,3-disulphonate

Cas Number:

83763-34-2

Molecular formula:

C6H7NO7S2.K

IUPAC Name:

potassium hydrogen -5-amino-4-hydroxybenzene-1,3-disulphonate

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

- Animal specifics: New Zealand White, KFM
- Source: Kleintierfarm Madoerin AG, CH 4414 Fuellingsdorf, Switzerland
- Age at study initiation:15 to 16 weeks
- Weight at study initiation: 2.5 kg to 2.6 kg
- Acclimation period: 5 days
- Housing: individual cages

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg

Duration of treatment / exposure:

One administration 72 hours

Observation period (in vivo):

3 days

Number of animals or in vitro replicates:

2

Details on study design:

eyes were not rinsed at any time after administration of the test substance
TOOL USED TO ASSESS SCORE: eye examinations were performed with a split-lamp 30 SL (C. Zeiss AG, Zuerich, Switzerland) and a Varta Cliptrix diagnostic-lamp (A. Riegger, Basel, Switzerland)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: # 149 - male

Time point:

other: mean after 24, 48 and 72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal: # 150 - female

Time point:

other: mean after 24, 48 and 72 h

Score:

2.7

Max. score:

2

Reversibility:

not fully reversible within: 72 hours

Results 3

Irritation parameter:

iris score

Basis:

animal: # 149 - male

Time point:

other: mean after 24, 48 and 72 h

Score:

0.3

Max. score:

2

Reversibility:

fully reversible within: 72 hours

Results 4

Irritation parameter:

iris score

Basis:

animal: # 150 - female

Time point:

other: mean after 24, 48 and 72 h

Score:

1

Max. score:

2

Reversibility:

not fully reversible within: 72 hours

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal: # 149 - male

Time point:

other: mean after 24, 48 and 72 h

Score:

1.7

Max. score:

3

Reversibility:

not fully reversible within: 72 hours

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal: # 150 - female

Time point:

other: mean after 24, 48 and 72 h

Score:

2.7

Max. score:

3

Reversibility:

not fully reversible within: 72 hours

Results 7

Irritation parameter:

chemosis score

Basis:

animal: # 149 - male

Time point:

other: mean after 24, 48 and 72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Results 8

Irritation parameter:

chemosis score

Basis:

animal: # 150 - female

Time point:

other: mean after 24, 48 and 72 h

Score:

3

Max. score:

4

Reversibility:

not fully reversible within: 72 hours

Irritant / corrosive response data:

Irritant effects refering to redness of conjunctiva, cornea opacity and chemosis were evident in both animals 1 h after treatment (score 2 in all 3 animals).
In the area of application no discolouration of the cornea and conjunctiva was observed which could be related to effects of the test item. No corrosion was observed at each of the measuring intervals.

Any other information on results incl. tables

Results table:

Animal	Evaluation after administration	Opacity of cornea	Iris	Redness of conjunctiva	Chemosis
# 149 - male	1 hour	1	0	1	2
# 150 - female		1	0	1	2
# 149 - male	24 hours	1	0	2	1
# 150 - female		2	1	2	3
# 149 - male	48 hours	1	1	2	0
# 150 - female		3	1	3	3
# 149 - male	72 hours	0	0	1	0
# 150 - female		3	1	3	3

 

Applicant's summary and conclusion

Interpretation of results:

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

Conclusions:

The test substance caused scores in all irritation parameters which were not fully reversible in one animal during the observation period. Conjunctiva redness was not reversible in both animals. Observed irritation effects persistent after 72 hours are not expected to reverse within a prolonged observation period of 21 days.

Executive summary:

A study with the test item according to OECD Guideline 405 and EU Method B.5 was performed to investigate the irritation potential to the rabbit eye. In a screening test the test substance was administered to one female and one male New Zealand White rabbit.

Whereas effects refering to opacity of cornea, iris and chemosis were fully reversible in the male animal all effects observed in the female were not reversible. Conjunctiva redness was not reversible in both animals. Observed irritation effects persistent after 72 hours are not expected to reverse within a prolonged observation period of 21 days.

In addition, a 10 % aqueous solution of the submission substance has a pH of 1.5.

Therefore, the submission substance has to be classified as eye irritant, category 1.