3-(2-hydroxyethyl)-p-phenylenediammonium sulphate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3-(2-hydroxyethyl)-p-phenylenediammonium sulphate

EC Number:

298-995-1

EC Name:

3-(2-hydroxyethyl)-p-phenylenediammonium sulphate

Cas Number:

93841-25-9

Molecular formula:

C8H12N2O.H2O4S

IUPAC Name:

2-(2,5-Diaminophenyl)ethanol sulfate (1:1)

Specific details on test material used for the study:

Trade name : Betoxol
Purity : 99.8%

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Test system

Vehicle:

other: water to form paste

Controls:

yes, concurrent no treatment

Amount / concentration applied:

60mg

Duration of treatment / exposure:

Single samples were instilled into one eye of each of three rabbits

Observation period (in vivo):

Observations were made 1, 24, 48 and 72 hours, 7 and 14 days after instillation

Number of animals or in vitro replicates:

Three male animals

Details on study design:

A health inspection was performed prior to the commencement of treatment. special attention was paid to the eyes which were free from any abnormality. Each animal was treated by instillation of 60mg of the test substance in the conjunctival sac of one of the eyes after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of the test substance. The other eye remained untreated and served as the reference control. After the 24 hour observation, a solution of 2% fluorescein in water was instilled into both eyes of each animal to quantitatively determine corneal epithelial damage. Any bright green stained area, indicating epithelial damade, was estimated as a percentage of the total corneal area. Observations were made 1, 24, 48 and 72 hours, 7 and 14 days after instillation. The irritation scores and a description of all other (local) effects were recorded.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.3

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.3

Results 6

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.3

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2.3

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

3

Results 10

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.7

Results 11

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.3

Irritant / corrosive response data:

Instillation of the test substance resulted in effects on the iris and conjunctivae. Iridial irritation (grade 1) was observed in all animals after 1 and 24 hours. Irritation of the conjunctivae was seen as redness, chemosis and discharge, which had completely resolved within 7 days in two animals and within 14 days in the other animal. No corneal opacity was observed and treatment of the eyes with 2% fluorescein 24 hours after test substance instillation revealed no corneal epithelial damage in any of the animals. There was no evidence of ocular corrosion. No staining of peri-ocular tissues by the test substance was observed.

Other effects:

No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

Under the conditions of the test, undiluted 2-(2,5-diaminophenyl)ethanol sulfate (Betoxol) was irritant to the rabbit eye.

Executive summary:

The acute eye irritation/corrosion potential of the test item Betoxol was assessed in a study performed according to OECD guideline 405. Single samples of approximately 60 mg of Betoxol were instilled into one eye of each of three rabbits. Observations were made 1, 24, 48 and 72 hours, 7 and 14 days after instillation. Instillation of the test substance resulted in effects on the iris and conjunctivae. Iridial irritation (grade 1) was observed in all animals after 1 and 24 hours. Irritation of the conjunctivae was seen as redness, chemosis and discharge, which had completely resolved within 7 days in two animals and within 14 days in the other animal. Under the conditions of the test the undilute substance was irritant to the rabbit eye.