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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
Study period:
1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Dioctyl ether
EC Number:
211-112-6
EC Name:
Dioctyl ether
Cas Number:
629-82-3
Molecular formula:
C16H34O
IUPAC Name:
1-(octyloxy)octane
Test material form:
liquid
Details on test material:
- State of aggregation: Colorless, clear liquid
Specific details on test material used for the study:
- Name of test material (as cited in study report): di-n-octylether
- Physical state: colorless liquid
- Purity: >99.9%
- Stability: stable at temperatures up to 40°C

Test animals / tissue source

Species:
rabbit
Strain:
other: Kleinrussen Chbb:HM
Details on test animals or tissues and environmental conditions:
according to guideline

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
application volume: 0.1 mL undiluted
Duration of treatment / exposure:
24 h
Observation period (in vivo):
72 h after instillation
Number of animals or in vitro replicates:
3
Details on study design:
according to guideline

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0.3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
>= 2 - < 3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
>= 1 - <= 1.5
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Remarks:
erythema
Basis:
mean
Time point:
24/48/72 h
Score:
>= 2.5
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Remarks:
edema
Basis:
mean
Time point:
24/48/72 h
Score:
> 2
Reversibility:
fully reversible within: 72 h

Any other information on results incl. tables

Table 1: Evaluation of the eye reactions

Animal No.

Hours after application

1

24

48

72

A

B

C

D

L

A

B

C

D

L

A

B

C

D

L

A

B

C

D

L

1270

1272

1273

0

0

0

0

0

0

1

2

1

1

1

0

1

1

0

0

0

0

0

0

0

1

1

0

0

1

0

0

0

0

0

0

0

0

0

0

0

1

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

A effects on cornea (turbidity degree)

B effects on iris (intensity)

C erythema (conjunctival reaction)

D edema (conjunctival reaction)

L lacrimation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Only mild effects were observed that were fully reversible within 3 days. Therefore, the substance is considered to be slightly irritating.
Executive summary:

An aliquot of 0.1 ml aqueous solution of the test article was instilled by a single application for a 24h contact into the eyes of 3 rabbits. The eyes were scored 24, 48 and 72 hours after application. The 24/48/72 hours mean scores were 0 for the cornea, 0 for the iris, 0.33 for the conjunctival erythema and 0.11 for the conjunctival oedema. The conjunctiva reactions abated completely within 72 hours. In summary, only mild effects were observed that were fully reversible. Therefore, the substance is considered to be slightly irritating. GHS criteria for classification and labelling are not fulfilled.