Reaction mass of 2,2',2''-nitrilotriethanol and 2,2'-[[2-[(2-hydroxyethyl)amino]ethyl]imino]bisethanol and 2,2'-iminodiethanol

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

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

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

Test material information

Constituent 1

Reference substance name:

2,2',2''-nitrilotriethanol

EC Number:

203-049-8

EC Name:

2,2',2''-nitrilotriethanol

Cas Number:

102-71-6

Molecular formula:

C6H15NO3

IUPAC Name:

2,2',2''-nitrilotriethanol

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

Results

Results 1

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Time point:

24/48/72 h

Score:

0

Reversibility:

fully reversible within: 1 day

Remarks on result:

other: 0.01 mL

Results 2

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Time point:

24 h

Score:

1

Reversibility:

fully reversible within: 3 days

Remarks on result:

other: 0.03 mL

Results 3

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Time point:

24 h

Score:

4

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: 0.1 mL

Results 4

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