Isopropylamine

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

Remarks:

only one animal

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Isopropylamine

EC Number:

200-860-9

EC Name:

Isopropylamine

Cas Number:

75-31-0

Molecular formula:

C3H9N

IUPAC Name:

propan-2-amine

Test material form:

liquid

Details on test material:

Isopropylamine [CAS No. 75-31-0], batch C-899, not further specified
purity > 99%, for further details, please see statement on test material purity for older studies on isopropylamine, attached in IUCLID section 13

Test animals / tissue source

Species:

rabbit

Strain:

not specified

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.1 ml undiluted applied

Duration of treatment / exposure:

24 h

Observation period (in vivo):

24 h

Number of animals or in vitro replicates:

1

Details on study design:

not rinsed

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

animal #1

Time point:

24 h

Score:

80

Max. score:

110

Reversibility:

not reversible

Remarks on result:

other: corrosive

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Remarks on result:

not determinable

Remarks:

animal was killed at 24 hours, for humane reasons

Results 3

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Remarks on result:

not determinable

Remarks:

animal was killed at 24 hours, for humane reasons

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Remarks on result:

not determinable

Remarks:

animal was killed at 24 hours, for humane reasons

Results 5

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Remarks on result:

not determinable

Remarks:

animal was killed at 24 hours, for humane reasons

Any other information on results incl. tables

At 24 h the animal exhibited moderate to severe conjunctival irritation (redness, chemosis, discharge, and necrosis) and corneal opacity, stippling and ulceration (The iris could not be evaluated). The animal was killed after 24 h, for humane reasons. The total score was 80 (Draize score system).

Applicant's summary and conclusion

Interpretation of results:

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

Conclusions:

Under the conditions of this study, the test substance was corrosive to the eye. For human reasons, the animal was sacrificed after 24 h. Therefore no 24/48/72 h scores could be calculated.

Executive summary:

The test substance (0.1 mL) was applied to the eye of one rabbit. At 24 h the animal exhibited moderate to severe conjunctival irritation (redness, chemosis, discharge, and necrosis) and corneal opacity, stippling and ulceration (The iris could not be evaluated). The animal was killed after 24 h, for humane reasons. The total score was 80 (Draize score system). No 24/48/72 h scores could be calculated.