Tris(2-hydroxyethyl)ammonium acetate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

1996-06-28 to 1996-08-23

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study is the result of a structural analogue substance used as read-across substance. Study is conducted according to Guidelines in a GLP certified laboratory.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: Toxic Substance Control Act (TSCA), 40 CFR, Part 798, Subpart E, Specific Organ/Tissue Toxicity, Primary Eye Irritation, 798.4500

Deviations:

no

GLP compliance:

yes

Remarks:

Self Certified

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

427-360-5

EC Name:

-

IUPAC Name:

427-360-5

Details on test material:

Description: Light Yellow Solid
Stability of test compound: Stable

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Number 6
Sex Male and female
Age: 10 – 12 weeks old
Weight at dosing: Between 2.0 and 3.0 kilograms
Source: Purchased from a registered commercial breeder
Acclimatisation period: Minimum 5 days under the same conditions as for the acute test.
Diet: Commercial rabbit ration, ad libium
Water: Tap water, ad libium
Housing: Individually housed
Environmental conditions -
Temperature: 63 - 73°F
Humidity 30-70%
Air changes: 10 to 15
Photoperiod: 12-hour light/dark cycle, full spectrum fluorescent lights.

Test system

Vehicle:

not specified

Controls:

not required

Amount / concentration applied:

0.1 mL of the test substance was instilled into the left eye of each animal

Duration of treatment / exposure:

The eyes of the test animals were not washed out for 24 hours following instilation of the test substance. After the 24 hour reading, all eyes were washed with 0.9% Sodium Chloride for Infection USP.

Observation period (in vivo):

Eyes were examined at 1, 24, 48 and 72 hours post treatment, using the Draize scale. Since there was no irritation at 72 hours, the study was discontinued.

Number of animals or in vitro replicates:

Six animals were tested.

Details on study design:

The left eye of each animal was treated with a single dose of the test substance. The right eye remained untreated and thus served as a control.
Eyes were examined at 1, 24, 48, and 72 hours post-treatment, using the Draize scale. Since there wsa no irritation at 72 hours, the study was discontinued. Fluorescein staing was use during each examination, exluding the 1 hour exam. The examinations were facilitated by the use of a slit-lamp.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 1 h, 24 h, 48 h and 72 h

Score:

0

Max. score:

0

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 1 h, 24 h, 48 h and 72 h

Score:

0

Max. score:

0

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 1 hour

Score:

0

Max. score:

0

Irritant / corrosive response data:

No overt signs of toxicity were evident during the course of the study in any animals. No TSCA positive reactions for eye irritation were observed in any of the test or control animals at any of the observation points. Blistering of the nictitating membrane was observed in 2/6 animals at the 1 hour and 24 hour points. no fluorescein staining was evident in any of the test animals prior to treatment or at 24, 48 or 72 hours following treatment. There were no animals with positive TSCA scores for ocular irritation.

Other effects:

All animals exhibited an increase in body weight during the course of the study.

Any other information on results incl. tables

Table I: Lesion summary sheet (treated eye).

Lesion	Number of positive responses/Total number of test eyes
	1 hour	24 hour	48 hour	72 hour
Cornea
Opacity	0/6	0/6	0/6	0/6
Iris
Conjunctiva	0/6	0/6	0/6	0/6
Redness
Chemosis	0/6	0/6	0/6	0/6

Table II: Body weights and clinical observations, summary of clinical observations on Day 0 through Day 3.

		Body Weight (Kg)
Animal #	Sex	Day 0	Day 3	Weight Change	Signs of Toxicity*
60905	Male	2.36	2.41	0.05	None
60906	Female	2.27	2.31	0.04	None
60907	Male	2.39	2.43	0.04	None
60908	Female	2.24	2.29	0.05	None
60909	Male	2.41	2.46	0.05	None
60910	Female	2.31	2.37	0.06	None

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

Based on the results of this study, the test substance, RA2, is not considered an eye irritant to the ocular tissue of albino rabbits.

Executive summary:

The test substance was evaluated for its potential to produce an irritating effect on the ocular tissue of New Zealand White rabbits. The test susbtance was administered according to the procedures detailed in the study protocol.

No TSCA positive reations for eye irritation were observed in any test or control animals at any of the observation periods. Blistering of the nicitating membrane was observed in 2/6 animals at the 1 hour and 24 hour timepoints. In addition, no overt signs of toxicity were evident following treatment with the test substance and all of the animals exhibited an increase in body weight during the course of the study.

Based on the results of this study, the test substance, RA2, is not considered an eye irritant to the ocular tissue of albino rabbits.