Cyclopentadecanone

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

April 1986

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

May 12, 1981

Deviations:

yes

Remarks:

Observation period 72 hours

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: EWG Directive 84/449/EWG, Amtsblatt der Europaeischen Gemeinschaften L 251, Jahrgang 27, 19.9.84 B.5 . Akute Toxizitaet - Augenreizung / 109

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Cyclopentadecanone

EC Number:

207-951-2

EC Name:

Cyclopentadecanone

Cas Number:

502-72-7

Molecular formula:

C15H28O

IUPAC Name:

cyclopentadecanone

Test material form:

other: wax-like mass

Details on test material:

- State of aggregation: wax-like mass

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 6002

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Remarks:

KFM (SPF-quality)

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH 4414 Fuellinsdorf, Switzerland
- Age at study initiation: 15-16 weeks
- Weight at study initiation: 2.4-2.8 kg
- Housing: individually in stainless steel cages equipped with an automatic cleaning and drinking system (Dipl. Ing. W. Ehret GmbH).
- Diet (e.g. ad libitum): pelleted standard Kliba 341, batch 14/B6 rabbit maintenance diet ("Kliba", Klingentalmuehle AG, 4303 Keiseraugst, Switzerland), ad libitum
- Water (e.g. ad libitum): community tap water from Itingen, ad libitum
- Acclimation period: three days under laboratory conditions after veterinary examination

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: April 14, 1986 To: April 17, 1986

Test system

Vehicle:

not specified

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
- Concentration (if solution): 100% (pure substance) or 30% dilution

Duration of treatment / exposure:

Single instillation

Observation period (in vivo):

1, 24, 48 and 72 hours post-administration

Number of animals or in vitro replicates:

3 (2 males, 1 female)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not performed

SCORING SYSTEM: Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Remarks:

100% pure substance

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no corneal effects observed in any animal at any time point

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

iris score

Remarks:

100% pure substance

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: no effects on iris observed in any animal at any time point

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Remarks:

100% pure substance

Basis:

mean

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Remarks on result:

probability of weak irritation

Results 4

Irritation parameter:

chemosis score

Remarks:

100% pure substance

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 hours post-instillation

Remarks on result:

probability of weak irritation

Results 5

Irritation parameter:

cornea opacity score

Remarks:

30% dilution

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no corneal effects noted in any animal at any time point

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

iris score

Remarks:

30% dilution

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: no iris effects observed in any animal at any time point

Remarks on result:

no indication of irritation

Results 7

Irritation parameter:

conjunctivae score

Remarks:

30% dilution

Basis:

mean

Time point:

24/48/72 h

Score:

0.11

Max. score:

3

Reversibility:

fully reversible within: 48 hours post-instillation

Remarks on result:

probability of weak irritation

Results 8

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects observed in any animal at any time point

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

100% pure substance:
After 1 hour, erythema (general, severe in one animal) and ventral edema (slight in one animal) of the conjunctiva was observed in all three rabbits. Severe discharge and erythema of the sclera (slight in one animal) were observed in all animals. Furthermore, test article remains, partly white mass, were observed in one out of three animals.
After 24 hours, conjunctival and scleral erythema were observed in all animals.
After 48 and 72 hours, no abnormal changes were noted in any animal.

30% dilution:
After 1 hour, ventral conjunctival erythema was observed in 2 out of 3 animals. Furthermore, test article remains, ventral erythema of the sclera and slight discharge were observed in 1 out of 3 animals.
After 24 hours, slight, hardly perceptible erythema of conjunctivae and ventral erythema of the sclera, as well as test article remains were noted in one out of three animals.
After 48 and 72 hours, no abnormal changes were noted in any animal.

Other effects:

- Lesions and clinical observations: in the area of application no discoloration of the cornea and conjunctivae was observed which could be related to the color to the test article.
- Other observations: the body weight gain of all rabbits was similar. Due to the results obtained, no macroscopic organ examination was indicated.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In the reliable guideline study with rabbits, cyclopentadecanone administered as a pure substance and at 30% dilution was not irritating to rabbit eyes.

Executive summary:

In a reliable study performed according to OECD Guideline 405, 0.1 g cyclopentadecanone was instilled into eyes of three rabbits either as a pure substance or at 30% dilution. The average scores over 24, 48 ad 72 hours in case of pure substance were 0 for corneal opacity, 0 for iritis, 0.33 for conjunctival erythema and 0 for chemosis. In case of 30% dilution, the average scores over 24, 48 and 72 hours were 0 for corneal opacity, 0 for iritis, 0.11 for conjunctival erythema and 0 for chemosis. All observed effects were fully reversible within max. 48 hours. Based on these results, classification of cyclopentadecanone for eye irritation is not required.