2-ethylhexylamine

Eye irritation

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:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1968

Report date:

1968

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

See "any other information on materials and methods".

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-ethylhexylamine

EC Number:

203-233-8

EC Name:

2-ethylhexylamine

Cas Number:

104-75-6

Molecular formula:

C8H19N

IUPAC Name:

2-ethylhexylamine

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent vehicle

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.05 mL
- Concentration: undiluted

Duration of treatment / exposure:

not applicable because test substance remained in the eye and was not washed out.

Observation period (in vivo):

8 days

Number of animals or in vitro replicates:

2

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: none


SCORING SYSTEM: The original scoring system was converted into Draize scores.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

not reversible

Remarks on result:

probability of severe irritation

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

not reversible

Remarks on result:

probability of severe irritation

Results 3

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

not reversible

Remarks on result:

probability of severe irritation

Results 4

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

not reversible

Remarks on result:

probability of severe irritation

Results 5

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Remarks on result:

not determinable

Remarks:

due to severe effects on the eye

Results 6

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Remarks on result:

not determinable

Remarks:

due to severe effects on the eye

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Remarks on result:

not determinable

Remarks:

due to severe effects on the eye

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Remarks on result:

not determinable

Remarks:

due to severe effects on the eye

Irritant / corrosive response data:

After 8 days severe chemical burnings of eyelids and eye ball, iritis, crust formation on eye lids, secretion of pus and loss of bulbus was observed.

Any other information on results incl. tables

Readings	Animal	Cornea		Iris	Conjunctiva			Additional findings
		op	ar		red	ch	di
1 h	1	3	nd	nd	nd	2	nd	conjunctiva brown colored and burned
	2	3	nd	nd	nd	2	nd	conjunctiva brown colored and burned
24 h	1	3	nd	nd	nd	nd	nd	chemical burnings of eyelids and eye ball
	2	3	nd	nd	nd	nd	nd	chemical burnings of eyelids and eye ball, iritis
48 h	1	3	nd	nd	nd	nd	nd	chemical burnings of eyelids and eye ball
	2	3	nd	nd	nd	nd	nd	chemical burnings of eyelids and eye ball, iritis
72 h	1	3	nd	nd	nd	nd	nd	chemical burnings of eyelids and eye ball, iritis, crust formation on eye lids, secretion of pus
	2
6 d	1	3	nd	nd	nd	nd	nd	chemical burnings of eyelids and eye ball, iritis, crust formation on eye lids, staphyloma
	2							chemical burnings of eyelids and eye ball, iritis, crust formation on eye lids, secretion of pus, staphyloma
8 d	1	3	nd	nd	nd	nd	nd	chemical burnings of eyelids and eye ball, iritis, crust formation on eye lids, loss of bulbus
	2							chemical burnings of eyelids and eye ball, iritis, crust formation on eye lids, secretion of pus, loss of bulbus
Mean 24 -72 h	1	3	nd	nd	nd	nd	nd
	2	3	nd	nd	nd	nd	nd
Mean 24-72 h	1-2	3	nd	nd	nd	nd	nd

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria