Cyclopentanone

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:

other: The used protocol was the method published by the OECD. However, the purity of the test substance was not noted and the GLP were not mentioned. The number of scores were not detailed.

Data source

Reference

Reference Type:

publication

Title:

Evaluation of the ocular-irritation potential of 56 compounds

Author:

Guillot JP, Gonnet JF, Clement C, Caillard L, Truhaut R

Year:

1982

Bibliographic source:

Food Chem Toxicol, 20, 573-582

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

not specified

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Cyclopentanone

EC Number:

204-435-9

EC Name:

Cyclopentanone

Cas Number:

120-92-3

Molecular formula:

C5H8O

IUPAC Name:

cyclopentanone

Details on test material:

no data

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS:
- Source: Roucher SA, Couhé
- Weight at study initiation: about 2.5 kg
- Age at study initiation, housing, diet, water, acclimation period data not available

ENVIRONMENTAL CONDITIONS (temperature, humidity, air changes, photoperiod): data not available

IN-LIFE DATES: data not available

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the other eye served as control

Amount / concentration applied:

undiluted
Amount applied: 0.1 ml

Duration of treatment / exposure:

not rinsed or rinsed after 4 and 30 s

Observation period (in vivo):

observation at 1 h, 1, 2, 3, 4 and 7 days after instillation and, in case where lesion persisted, also at later stages

Number of animals or in vitro replicates:

6

Details on study design:

- Removal of test system: washing with Dacryoserum after 4 or 30 s (or not rinsed)

- Scoring system: at each observation time, lesions of the conjonctiva, iris and cornea were recorded separately using a numerical system based on that of Kay & Calandra (1962), the sum of these scores being the individual ocular irritation index (IOI) of each animal. Calculation of the mean of the IOI values (over six rabbits) gave the mean ocular irritation index (MOI). The greatest MOI obtained over the range of observation times was identified as the acute ocular irritation index (AOI; corresponding to the OECD approach) which was used for the classification of the substance in one of six categories between "non-irritant" and "extremely irritant" (AFNOR scale). The maximum value of index is 110.

- Tool used to assess score: data not available

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: AOI

Score:

54.33

Max. score:

110

Reversibility:

not specified

Remarks on result:

other: see results below

Results 2

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Results 3

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Results 4

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Results 5

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Any other information on results incl. tables

- Irritation score: 
Rinsing        AOI (*)                MOI                IOI
procedure
None                54.33                43.67 [d7]         > 30 (d4)
30 sec              49.67                17.50 [d7]         > 30 (d1)
4 sec                54.66                20.67 [d7]
*: the AOI was the 24-hr MOI

- Remarks: Cyclopentanone is considered as "severely irritant" according to the AFNOR quotation since: 
        -  IOI at day 7 was > 30 without rinsing (for 4 rabbits / 6 rabbits) and with rinsing at 30 seconds (1 rabbit / 3 rabbits).
        - MOI after 7 days was 43.67 without rinsing, 17.50 after rinsing at 30 seconds and 20.67 after rinsing at 4 seconds.
        - AOI = 54.33 of the OECD approach without rinsing procedure. After rinsing at 30 or 4 seconds, AOI (at 24 hours) was 49.67 or 54.66 respectively. 

Rinsing reduced the severity of the eye lesions and even affected a significant reversibility by day 14 or 21, although rinsing at 4 or 30 seconds did not change the classification.

Applicant's summary and conclusion

Interpretation of results:

other: Irritating to the eye. Classified as irritant in the annex VI 3.2 of the CLP regulation 1272/2008

Conclusions:

Irritating to the eye.
Classified as irritant in the annex VI 3.2 of the CLP regulation 1272/2008

Executive summary:

In a primary eye irritation study [Guillot, 1982], 0.1 mL of undiluted cyclopentanone (purity unknown) was instilled into the conjunctival sac of the eye of New Zealand White rabbits (6/group). The eyes were not rinsed, or rinsed after 4 or 30 sec. Animals then were observed for at least 7 days.  Irritation was scored by the method of Kay & Calandra, and using the AFNOR scale.

In this study, cyclopentanone was irritating to the eye.