(2-hydroxyethyl)ammonium nitrate

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: Acceptable non-GLP study, comparable to guideline

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

not applicable

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Principles of method if other than guideline:

Before OECD Guideline 405 was first adopted in 1981, eye irritation was tested using a BASF test.
The methods were based on Draize (Federal Register 38, No. 187, § 1500.42, p. 27019 (1973-09-27)).

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-hydroxyethylammonium chloride

EC Number:

217-900-6

EC Name:

2-hydroxyethylammonium chloride

Cas Number:

2002-24-6

IUPAC Name:

2-hydroxyethanaminium chloride

Details on test material:

- Name of test material: Härter 421 flüssig; Äthanolaminhydrochlorid 45 % (German)
- Physical state: liquid

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

no data

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 100 µL

Duration of treatment / exposure:

single treatment

Observation period (in vivo):

not reported (the standard duration of the observation period in the BASF test on eye irritation was 7 or 8 days)

Number of animals or in vitro replicates:

6 rabbits (4 males, 2 females)

Details on study design:

SCORING SYSTEM:
Draize scoring system
Based on the Draize scores, a primary irritation index was calculated (max. score: 110).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

(animals #1, #3, #4, #6)

Time point:

other: 24/48/72 hours

Score:

0

Max. score:

4

Results 2

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

(animal #2)

Time point:

other: 24/48/72 hours

Score:

0.33

Max. score:

4

Reversibility:

not specified

Remarks on result:

other: finding noted at 72 hours only (score 1)

Results 3

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

(animal #5)

Time point:

other: 24/48/72 hours

Score:

0.33

Max. score:

4

Reversibility:

not specified

Remarks on result:

other: finding noted at 72 hours only (score 1)

Results 4

Irritation parameter:

iris score

Basis:

mean

Remarks:

(all animals)

Time point:

other: 24/48/72 hours

Score:

0

Max. score:

2

Results 5

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

(animal #1)

Time point:

other: 24/48/72 hours

Score:

0

Max. score:

3

Results 6

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

(animal #2)

Time point:

other: 24/48/72 hours

Score:

1

Max. score:

3

Reversibility:

not fully reversible within: 72 hours

Results 7

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

(animal #3)

Time point:

other: 24/48/72 hours

Score:

1

Max. score:

3

Reversibility:

not fully reversible within: 72 hours

Results 8

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

(animal #4)

Time point:

other: 24/48/72 hours

Score:

1

Max. score:

3

Reversibility:

not fully reversible within: 72 hours

Results 9

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

(animal #5)

Time point:

other: 24/48/72 hours

Score:

0.67

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Results 10

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

(animal #6)

Time point:

other: 24/48/72 hours

Score:

1.33

Max. score:

3

Reversibility:

not fully reversible within: 72 hours

Results 11

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

(animals #1, #2, #3, #4, #5)

Time point:

other: 24/48/72 hours

Score:

0

Max. score:

4

Results 12

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

(animal #6)

Time point:

other: 24/48/72 hours

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: finding noted at 24 hours only (score 2)

Irritant / corrosive response data:

Slight conjunctival redness was the main test substance-related finding noted in 5/6 rabbits with mean scores (24/48/72 hours) ranging from 0.67 to 1.33. In 1/6 animals chemosis was observed after 24 hours resulting in a mean chemosis score of 0.67 for this rabbit. In 2/6 rabbits a very slight corneal opacity was noted at the 72-hours reading resulting in a mean score (24/48/72 hours) of 0.33 for each of the two rabbits. Reversibility was not assessed in this study (no 8-day observation reported); however there was a general trend towards reversibility within the 72-hour observation period.

The primary irritation index was calculated to be 3.0.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU