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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: Well documented publication which meets basic scientific principles

Data source

Reference
Reference Type:
publication
Title:
Dose-Response Studies with Chemical Irritants in the Albino Rabbit 1 Eye as a Basis for Selecting Optimum Testing Conditions for Predicting Hazard to the Human Eye
Author:
Griffith JF, et al.
Year:
1980
Bibliographic source:
Toxicology and Applied Pharmacology 55, 501-513 (1980)

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
Draize Test according to Draize JH, Woodard G and Galvery HO. J. Pharmacol. Exp. Ther. 82:377, 1944. and
CEPA (Corneal Epithelial Plasminogen Activator) Test
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
- Name of test material (as cited in study report): Triethanolamine
- Analytical purity: 98 %

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.01, 0.03, and 0.1 ml.
- Concentration (if solution): unchanged
Duration of treatment / exposure:
not applicable (eyes were not washed out)
Observation period (in vivo):
21 day
Number of animals or in vitro replicates:
6 per dose

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 1, 3, 7, 14, 21 days
Score:
0
Reversibility:
fully reversible within: 1 day
Remarks on result:
other: 0.01 mL
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 1 day
Score:
1
Reversibility:
fully reversible within: 3 days
Remarks on result:
other: 0.03 mL
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 1 day
Score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: 0.1 mL
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 3, 7 days
Score:
2
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: 0.1 mL

Any other information on results incl. tables

Rabit eye irritation scores and days to clear with different dose volumes

Maximum Draize score (mean ±SE) Dose (ml)

Number of days to return to normal Dose (ml)

0.01

0.03

0.1

0.01

0.03

0.1

0 ± 0

1 ± 1

4 ± 1

1

1

3

 

Rabbit eye irritation scores at various times after instillation of TEA (Draize score (mean +/- SE)

Test material

Dose volume

Number of animals tested

Day

Maximum

Median day to clear

1

3

7

14

21

TEA

0.01

6

0 ± 0

0 ± 0

0 ± 0

0 ± 0

0 ± 0

0 ± 0

1

0.03

6

1 ± 1

0 ± 0

0 ± 0

0 ± 0

0 ± 0

1 ± 1

1

0.10

6

4 ± 1

2 ± 2

2 ± 2

0 ± 0

0 ± 0

6 ± 1

3

* Each value is the average ± SE for 6 animals.

 

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information