Dibutylamine

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:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Dibutylamine

EC Number:

203-921-8

EC Name:

Dibutylamine

Cas Number:

111-92-2

Molecular formula:

C8H19N

IUPAC Name:

N-butylbutan-1-amine

Details on test material:

Di-n-butylamine

Test animals / tissue source

Species:

rabbit

Strain:

not specified

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml

Duration of treatment / exposure:

no data

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

4

Details on study design:

not rinsed

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24 h

Score:

2.3

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24 h

Score:

>= 0.8 - <= 2

Max. score:

2

Reversibility:

fully reversible within: 8 days

Results 3

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24 h

Score:

2.3

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Results 4

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Any other information on results incl. tables

The test substance produced severe ocular irritation which persisted through Day 7 in two of the four animals. Responses seen at 24 hours included severe conjunctival irritation (redness, chemosis, discharge, necrosis), iridial changes or iritis and corneal opacity, stippling and ulceration and corneal bulging (indicative of increased intraocular pressure). By Day 7, two of the four animals still exhibited conjunctival irritation, iridial changes and corneal opacity, stippling and/or ulceration, corneal bulging and pannus (neovascilarization of the corneal surface). The other two animals exhibited only slight conjunctival irritation and/or iridial changes and stippling which were reversible after 7 d.

Applicant's summary and conclusion

Interpretation of results:

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

Conclusions:

4 rabbits were treated with 0.1 ml of the unchanged test substance (without rinsing) and observed for 7 days. The test substance produced severe ocular irritation which persisted through Day 7 in two of the four animals.

Executive summary:

4 rabbits were treated with 0.1 ml of the unchanged test substance (without rinsing) and observed for 7 days.

The test substance produced severe ocular irritation which persisted through Day 7 in two of the four animals. Responses seen at 24 hours included severe conjunctival irritation (redness, chemosis, discharge, necrosis), iridial changes or iritis and corneal opacity, stippling and ulceration and corneal bulging (indicative of increased intraocular pressure). By Day 7, two of the four animals still exhibited conjunctival irritation, iridial changes and corneal opacity, stippling and/or ulceration, corneal bulging and pannus (neovascilarization of the corneal surface). The other two animals exhibited only slight conjunctival irritation and/or iridial changes and stippling which were reversible after 7 d.