Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

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:
other: Acceptable study report which meets generally accepted scientific principles. Study is well documented, before OECD TG and GLP existed. The study is fully sufficient for endpoint evaluation.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
; observation period was 8 days (OECD: 21)
GLP compliance:
no
Remarks:
; GLP was not compulsory at the time the study was conducted

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Diisopropylamin
- Physical state: liquid
- Analytical purity: >= 99.0 %

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 3.10 kg, 3.44 kg, 3.3 kg

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the second eye of the same rabbit was untreated and served as control.
Amount / concentration applied:
undiluted
Amount applied: 0.1 ml
Duration of treatment / exposure:
24 h; the substance was not washed out
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
3 animals (2 males and 1 female)
Details on study design:
100 µl of the undiluted test substance was applied to the right conjuntival sac of one male and one female Vienna White rabbit. The left eye was left untreated and served as a control. The substance was not washed out.
Ocular reactions were recorded after 1, 24, 48 and 72 hours, as well as 6 and 8 days after instillation using a BASF-scoring system, which is convertible into the current OECD Draize scheme. For the evaluation, the BASF scores given in the raw data were converted to Draize scores. The reading time points used for assessment were 24, 48 and 72 hours after application.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24-48-72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 8 d
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24-48-72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 8 d
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24-48-72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 d
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24-48-72 h
Max. score:
2
Remarks on result:
other: Not readable
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24-48-72 h
Score:
0
Max. score:
2
Reversibility:
not fully reversible within: 8 d
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24-48-72 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 8 d
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24-48-72 h
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 8 d
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24-48-72 h
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 8 d
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24-48-72 h
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 8 d
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24-48-72 h
Score:
2.66
Max. score:
2
Reversibility:
not fully reversible within: 8 d
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24-48-72 h
Score:
2.66
Max. score:
3
Reversibility:
not fully reversible within: 8 d
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24-48-72 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 8 d
Other effects:
Autopsy revealed the following findings: infestation with parasites in the liver and sanious rhinitis.

Any other information on results incl. tables

Individual scores for eye irritation of the animals treated with the test material for 24 h

 

24 h

48 h

Rabbit No.

1

2

3

1

2

3

Cornea

4

4

2

4

4

2

Iris

-

0

1

-

0

1

Conjunctiva redness

2 Na

2

2 Na

2 Na

2 Na

2 Na

Conjunctiva chemosis

2 B

2 B

2 B

3 B

3

2 B

 

72 h

8 d

Rabbit No.

1

2

3

1

2

3

Cornea

4

4

2

-

4

2

Iris

-

0

1

-

-

1

Conjunctiva redness

2 Na

2 Na

2 Na

-

-

2 Na

Conjunctiva chemosis

3 B

3

2 B

2

3

2

Na = cicatrice

B = blood

Discharge was seen at any reading time point.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: other: REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 December 2008
Executive summary:

The potential of Diisopropylamine (DIPA) to induce ocular irritation was evaluated in rabbits according to a protocol similar to OECD 405 guideline. Hundred µl of the undiluted DIPA was applied to the right conjuntival sac to 3 Vienna White rabbits (2 males and 1 female) for 24 h; the substance was not washed out and the animals were observed during 8 days.

Corneal scores were 4, 4, 2 for animals 1, 2 and 3. Iris scores were 0 and 1 for animals 2 and 3 (animal 1 was unreadable). Conjunctivae scores were 2, 2, 2 for animals 1, 2 and 3. Chemosis scores were 2.66, 2.66, 2 for animals 1, 2 and 3.

Under these experimental conditions, DIPA was corrosive when administered by ocular route to rabbits.