Poly[oxy(methyl-1,2-ethanediyl)], .alpha.-(2-aminomethylethyl)-.omega.-(2-aminomethylethoxy)-

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1978-12-26 to 1979-01-17

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Remarks:

Study conducted with methods similar to OECD Guideline 405. However, limited details were provided on the animals, environmental conditions and the test substance.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

Limited details were provided on the animals, environmental conditions and the test substance.

GLP compliance:

no

Test material

Test material information

Constituent 1

Test material form:

liquid

Details on test material:

- Physical state: liquid
- Storage condition of test material: Room temperature

Specific details on test material used for the study:

- Name as cited in study report: Poly[oxy(methyl-1,2-ethanediyl)], alpha-(2-aminomethylethyl)-omega-(2-aminomethylethoxy)
- Substance type: Active
- Color: clear
- Date of receipt: 1978-11-3

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Housing: The animals were housed two per cage in suspended wire mesh cages in a temperature controlled room reserved exclusively for rabbits on acute tests.
- Diet (e.g. ad libitum): ad libitum (fresh Purina Rabbit Chow)
- Water (e.g. ad libitum): ad libitum (tap water)
- Acclimation period: at least one week
- Other: The animals were in good health when received from the local supplier and remained in good health during the equilibration period in the laboratory. The cages and room were kept clean in accordance with the standards of AAALAC of which the laboratory was an approved member. Prior to testing, the rabbits' eyes were closely examined for signs of irritation or damage. Only rabbit with healthy eyes were used.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The untreated eye of each animal served as a control.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml of the test substance was instilled into one eye of each rabbit. The lids were held together briefly to insure adequate distribution of the test substance over the surface of the eye.

Duration of treatment / exposure:

No data were provided in the study on washing the eye after treatment. The eyes were scored up for up to 14 days.

Observation period (in vivo):

14 days (The ocular reactions were graded at 1, 24, 48 and 72 hours and again at 7 days. If any corneal score was present on day 7, the eyes were scored again at 14 days.)

Number of animals or in vitro replicates:

6

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The study did not specify if washing was done.


SCORING SYSTEM: The eye irritation potential was determined as defined in 16 CFR 1500.3 and 1500.42. See below for scale used for scoring of ocular lesions (Draize, J.H. et al. J. Pharm. Exp. Ther. 82:377-390, 1944).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Time point:

other: 1 h

Score:

ca. 41.3

Max. score:

110

Reversibility:

not reversible

Results 2

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Time point:

other: 24 h

Score:

ca. 55.7

Max. score:

110

Reversibility:

not reversible

Results 3

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Time point:

other: 48 h

Score:

ca. 66.6

Max. score:

110

Reversibility:

not reversible

Results 4

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Time point:

other: 72 h

Score:

ca. 61.4

Max. score:

110

Reversibility:

not reversible

Results 5

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Time point:

other: 7 d

Score:

ca. 57.3

Max. score:

110

Reversibility:

not reversible

Results 6

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Time point:

other: 14 days

Score:

ca. 72

Max. score:

110

Reversibility:

not reversible

Irritant / corrosive response data:

The test substance was corrosive to the rabbit eye.

Other effects:

One animal died during the study.

Any other information on results incl. tables

Average Scores	1 h	24 h	48 h	72 h	7 d	14 d
Cornea (max 80)	18.3	30.0	40.8	34.2	35.0	54.0
Iris (max 10)	5.0	6.7	7.5	9.2	5.0	0.0
Conjunctivae (max 20)	18.0	19.0	18.3	18.0	17.3	18.0

 

Applicant's summary and conclusion

Interpretation of results:

corrosive

Conclusions:

The test substance was evaluated for eye irritation in New Zealand White rabbits. Based on the results, the test substance was determined to be corrosive to the eyes and considered to be classified as category 1 (serious eye damage) according to CLP Regulation.