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Diss Factsheets

Toxicological information

Eye irritation

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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: see 'Remark'
Remarks:
The study is comparable to OECD Guideline 405 with acceptable restrictions (partly limited documentation, e.g. no details about the test substance; 50 μl instead of 100 μl test substance instilled; scoring system not according to OECD405). Study sufficient for evaluation of this endpoint.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1970

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
scoring system; application volume
Principles of method if other than guideline:
Before OECD Guideline 405 was established, eye irritation was tested using an internal method (BASF test). White Vienna rabbits were used. Usually 50µl or mg of the test substance were applied to the conjunctival sac of one eye of 4 animals. The non- or saline-treated adjacent eye served as a control.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Propyl chloroformate
EC Number:
203-687-7
EC Name:
Propyl chloroformate
Cas Number:
109-61-5
Molecular formula:
C4H7ClO2
IUPAC Name:
propyl carbonochloridate
Details on test material:
- Name of test material (as cited in study report): n-Propyl-chlorkohlensaeureester
- Physical state: liquid
- Purity: approx. 95%
- Expiration date of the lot/batch: not reported
- Stability under test conditions: not reported
- Storage condition of test material: not reported

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Breeder
- Weight at study initiation: 2.0 - 2.74 kg

ENVIRONMENTAL CONDITIONS
not reported

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: one drop of saline into the other eye
Amount / concentration applied:
50 µl
Duration of treatment / exposure:
Treatment was once. The eye was left unwashed.
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
4 (2 animals in two trials)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
1.8
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not reversible

Any other information on results incl. tables

Descriptive scores of the raw data have been converted to Draize numerical scores. Reading differed slightly between the two trials; however, two readings were performed between 24 and 72 h in each trial.

Animal

Reading

Opacity

Iritis

Redness

Chemosis

Comment

1

24 h

3

2

2

2

 

2

24 h

3

2

2

2

bad feeding behaviour, lid detached, nictitating membrane with white layer

3

24 h

3

2

2

2

 

4

24 h

3

2

1

2

ulceration

1

48 h

3

2

2

2

 

2

48 h

3

2

2

2

 

3

72 h

3

2

2

2

severe ulceration

4

72 h

3

2

1

2

severe ulceration

1

5 d

3

2

2

2

 

2

5 d

3

2

2

2

 

3

4 d

3

2

2

2

severe ulceration, scare on upper lid

4

4 d

3

2

1

2

severe ulceration

1

7 d

3

2

2

2

haemorrhage

2

7 d

3

2

2

2

haemorrhage

3

7 d

3

2

1

1

scare on upper lid, ingrowing vessels, starting staphyloma, blood

4

7 d

3

2

1

2

severe ulceration, starting staphylom

1

8 d

3

2

2

2

haemorrhage

2

8 d

3

2

2

2

haemorrhage

3

8 d

3

2

1

1

scare on upper lid, ingrowing vessels, starting staphyloma, blood

4

8 d

3

2

1

2

severe ulceration, starting staphylom

mean

24 - 48/72 h

3.00

2.00

1.75

2.00

 

Applicant's summary and conclusion

Executive summary:

The study is comparable to OECD Guideline 405 with acceptable restrictions (partly limited documentation, e.g. no details about the test substance). The study is however sufficient for evaluation of this endpoint.

Conclusions

Due to the irreversible cornea opacity and staphyloma formation the test substance is classified as risk of serious damage to eyes (R41 according to EU classification criteria; eye irritation/corrosion Cat. 1 according to GHS criteria).