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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:
From November 13 to 20, 1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given: comparable to standard OECD test guideline No. 405 with the following deviations: 6 animals tested instead of 3. This deviation does not affect the reliability of this study.
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: Section 1500.42 - Hazardous Substances and Articles, Administration and Enforcement Regulations, Federal Register, Vol. 38. No. 187, P. 27019, 27 September 1973
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
(6 animal tested)
Principles of method if other than guideline:
Not applicable
GLP compliance:
no
Remarks:
(pre-GLP)

Test material

Constituent 1
Chemical structure
Reference substance name:
2-pentylcyclopentan-1-one
EC Number:
225-392-2
EC Name:
2-pentylcyclopentan-1-one
Cas Number:
4819-67-4
Molecular formula:
C10H18O
IUPAC Name:
2-pentylcyclopentan-1-one
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): P1078/2

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
Healthy young albino rabbits were used.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
Duration of treatment / exposure:
- Eyes of the animals were not rinsed.
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6 animals
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No

SCORING SYSTEM: According to the "Illustrated Guide for Grading Eye Irritation by Hazardous Substance"

TOOL USED TO ASSESS SCORE: No data

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2, #3, #4, #5 & #6
Time point:
other: mean 24, 48 and 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal: #1, #2, #3, #4, #5 & #6
Time point:
other: mean 24, 48 and 72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal: #1 & #4
Time point:
other: mean 24, 48 and 72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal: #1, #3, #5 & #6
Time point:
other: mean 24, 48 and 72 h
Score:
1.33
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: mean 24, 48 and 72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal: #2 & #5
Time point:
other: mean 24, 48 and 72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 5 days
Irritation parameter:
chemosis score
Basis:
animal: #3 & #4
Time point:
other: mean 24, 48 and 72 h
Score:
2.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
other: mean 24, 48 and 72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 5 days
Irritant / corrosive response data:
- Animals showed conjunctival reactions (redness, chemosis and discharge) which were reversible within 7 days.
Other effects:
None

Any other information on results incl. tables

Table 7.3.2/1: Eye irritation response data for each animal at each observation time

Score at time point

Cornea

Iris

(/2)

Conjunctivae

Opacity

(/4)

Area

(/4)

Redness

(/3)

Chemosis

(/4)

Discharge

(/3)

1 h

0 / 0 / 0 / 0 / 0 / 0

0 / 0 / 0 / 0 / 0 / 0

0 / 0 / 0 / 0 / 0 / 0

3 / 3 / 3 / 3 / 3 / 3

3 / 3 / 3 / 3 / 3 / 3

3 / 3 / 3 / 3 / 3 / 3

24 h

0 / 0 / 0 / 0 / 0 / 0

0 / 0 / 0 / 0 / 0 / 0

0 / 0 / 0 / 0 / 0 / 0

3 / 2 / 2 / 3 / 2 / 2

3 / 2 / 3 / 3 / 2 / 3

3 / 2 / 3 / 3 / 3 / 3

48 h

0 / 0 / 0 / 0 / 0 / 0

0 / 0 / 0 / 0 / 0 / 0

0 / 0 / 0 / 0 / 0 / 0

2 / 1 / 1 / 2 / 1 / 1

2 / 1 / 2 / 2 / 1 / 2

2 / 2 / 2 / 2 / 2 / 2

72 h

0 / 0 / 0 / 0 / 0 / 0

0 / 0 / 0 / 0 / 0 / 0

0 / 0 / 0 / 0 / 0 / 0

1 / 1 / 1 / 1 / 1 / 1

1 / 1 / 2 / 2 / 1 / 0

0 / 1 / 1 / 1 / 1 / 0

Day 5

0 / 0 / 0 / 0 / 0 / 0

0 / 0 / 0 / 0 / 0 / 0

0 / 0 / 0 / 0 / 0 / 0

1 / 0 / 1 / 0 / 0 / 0

2 / 0 / 1 / 0 / 0 / 1

0 / 0 / 1 / 0 / 0 / 0

Day 7

0 / 0 / 0 / 0 / 0 / 0

0 / 0 / 0 / 0 / 0 / 0

0 / 0 / 0 / 0 / 0 / 0

0 / 0 / 0 / 0 / 0 / 0

0 / 0 / 0 / 0 / 0 / 0

0 / 0 / 0 / 0 / 0 / 0

Average 24, 48 and 72 h

0 / 0 / 0 / 0 / 0 / 0

0 / 0 / 0 / 0 / 0 / 0

0 / 0 / 0 / 0 / 0 / 0

2 / 1.33 / 1.33 / 2 / 1.33 / 1.33

2 / 1.33 / 2.33 / 2.33 / 1.33 / 1.67

1.67 / 1.67 / 2 / 2 / 2 / 1.67

Reversibility

 -

 -

-

Completely

reversible

Completely reversible

Completely reversible

Average time (unit) for reversion

-

-

-

7 days

7 days

7 days

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the test conditions, the test material induced mild to moderate irritation being reversible within 7 days. Therefore, the test material is not classified as irritant to the eyes.
Executive summary:

In an eye irritation study performed similarly to OECD guideline No. 405, 0.1 g of undiluted test material was instilled into the right eye of 6 albino rabbits while the left eye remained untreated and served as control. The eyes were not rinsed after the instillation of test material. Animals were observed at 1, 24, 48 and 72 h after instillation of test material into eyes and then on Days 5 and 7. The reactions in the conjunctivae (redness, chemosis and discharge), the iris and the cornea (opacity and area involved) were scored according to the grading system outlined in the “Illustrated Guide for Grading Eye Irritation by Hazardous material”.

The calculated mean score for each animal within 3 scoring times (24, 48 and 72 h) were 2 / 1.33 / 1.33 / 2 / 1.33 / 1.33 for redness, 2 / 1.33 / 2.33 / 2.33 / 1.33 / 1.67 for chemosis, 0/0/0/0/0/0 for iris lesions and for corneal opacity.

The observed conjunctival reactions were fully reversible within 7 days. Under the test conditions, the test material is not classified as irritating to the eyes according to the annex VI of the Regulation EC No. 1272/2008 (CLP).

This study is considered as acceptable and satisfies the requirement for eye irritation endpoint.