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Toxicological information

Eye irritation

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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:
other: Guideline study with acceptable restrictions- incomplete characterization of the test substance (no data on test substance purity available)- no GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
N, N, N Trimethylaminoethyl-Ethanolamin

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
Source: Gaukler; D - 6050 Offenbach/Main, FRG
Weight at study initiation: 2.46 kg (male), 2.88 (female)
Housing: individually in stainless steel cages with wire mesh walk floors
Diet: Kliba 341, 4 mm, Klingentalmuehle AG, CH 4303, Kaiseraugst, Switzerland; available ad libitum (ca. 130 g per day per animal)
Water: about 250 mL tap water per animal per day; available ad libitum
Acclimation period: at least 8 days
ENVIRONMENTAL CONDITIONS
Temperature (°C): 20 - 24
Humidity (%): 30 -70
Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: left eye (untreated)
Amount / concentration applied:
Amount applied: 0.1 mL applied in to the conjuctival sac of the right eye.
Duration of treatment / exposure:
Eyes were not washed after application.
Observation period (in vivo):
15 days- Reading were performed 1, 24, 48, 72 hours, 8 and 15 days after application.
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE- Washing (if done): no
SCORING SYSTEM: Draize method

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not reversible
Remarks:
within 15 days
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
not reversible
Remarks:
within 15 days
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2.3
Max. score:
4
Reversibility:
not reversible
Remarks:
within 15 days
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 8 and 15 days
Score:
>= 4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
2
Reversibility:
not reversible
Remarks:
within 8 days
Remarks on result:
positive indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
not reversible
Remarks:
within 8 days
Remarks on result:
positive indication of irritation
Irritation parameter:
iris score
Remarks:
72 hour assessment could not be made
Basis:
animal #3
Time point:
24/48 h
Score:
1
Max. score:
2
Reversibility:
not reversible
Remarks:
within 48 hours
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 15 days
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
not reversible
Remarks:
within 15 days
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 15 days
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 15 days
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 15 days
Remarks on result:
no indication of irritation
Other effects:
See table 2: Table of symptoms

Any other information on results incl. tables

Observations

Parameter

Observation period

Animal 1

Animal 2

Animal 3

Cornea

1 hour

1

1

1

24 hours

1

1

2

48 hours

1

1

2

72 hours

1

2

3

8 days

2

3

4

15 days

2

2

4

Iris

1 hour

0

0

0

24 hours

0

1

1

48 hours

0

1

1

72 hours

1

1

a

8 days

1

1

a

15 days

b

b

a

Conjunctivae

1 hour

2

2

2

24 hours

2

2

2

48 hours

2

2

2

72 hours

2

2

2

8 days

2

2

2

15 days

1

2

1

Chemosis

1 hour

2

2

2

24 hours

1

2

2

48 hours

1

2

2

72 hours

1

2

2

8 days

0

1

1

15 days

0

0

0

a       reading cannot be made due to severe corneal opacity

b       reading cannot be made due to marginal vascularisation of the cornea

Table of symptoms

 

Animal 1

Animal 2

Animal 3

Discharge of blood

≥ 24 h – 48 h

≥ 1 h – 72 h

≥ 1 h – 72 h

Loss of corneal tissue

-

≥ 72 h – 8 d

≥ 1 h – 8 d

Loss of hair at margins of eyelids

-

≥ 8 – 15 d

≥ 8 – 15 d

Marginal vascularisation of the cornea

15 d

≥ 8 – 15 d

≥ 8 – 15 d

Pupil contracted

≥ 1 h – 8 d

≥ 1 h – 8 d

≥ 1 h – 48 h

Pannus

15 d

-

-

Small retractions in the eyelid

15 d

≥ 24 h – 15 d

≥ 72 h – 15 d

Suppuration

72 h

≥ 48 h – 15 d

≥ 48 h – 15 d

Staphyloma

-

15 d

15 d

After 15 days, the study was discontinued because of serious irritation effects on the eyes.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Conclusions:
For the animals exposed for 4 hours, the mean corneal score (24/48/72 hours) was 1.6, the mean conjunctivae score was 0.89 (24/48/72 hours) and the the mean chemosis score was 1.7 (24/48/72 hours). The mean iris score was 0.7 based on 2 animals (24/48/72 hours) and a score of 1 was assigned at both 24 and 48 hours for the third animal. Based on the corneal opacity score of 4 for one animal at 8 and 15 days and the irreversible damage, the test material is considered to cause serious eye damage (Category 1) according to CLP
Executive summary:

An in vivo eye irriation study was conducted in accordance with OECD 405 with test material N, N, N' Trimethylaminoethyl-Ethanolamin. The eyes of three Vienna white rabbits were instillated with 0.1 mL of test material. The test material was not removed. Observations were made 1, 24, 48 and 72 hours and 8 and 15 days after application. The material showed a mean value of 1.6 (24/48/72 hours) for corneal opacity, 2.0 (24/48/72 hours) for conjunctivae and 1.7 (24/48/72 hours) for chemosis. Due to the extent of corneal damage, iritis readings for 1 animal could not be made at 72 hours, however the mean for the remaining two animals was 0.7 (24/48/72 hours) with readings for the former animal were 1 at 24 and 48 hours. With the exception of chemosis which was reversible within at least 15 days, the damage was irreversible. The severity of cornea opacity increased for all three animals between 72 hours and 8 days and worsened or remained the same by 15 days; the opacity score for one rabbit was 4 at 8 and 15 days after installation. On the basis of the corneal opacity and the irreversible damage, the test material is considered to cause serious eye damage (Category 1).