Decan-4-olide

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Study period:

16-20 August 1999

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

GLP study conducted in compliance with OECD Guideline 405 (1987) with minor deviations: no certificate of analysis of the test substance; age of animals at start of study not reported. γ-Nonalactone, as aliphatic γ-lactone, is considered adequate for read-across purpose (see §"Toxicokinetics").

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

no certificate of analysis of the test substance; age of animals at start of study not reported; non-ocular local and systemic adverse effects not followed

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Nonan-4-olide

EC Number:

203-219-1

EC Name:

Nonan-4-olide

Cas Number:

104-61-0

Molecular formula:

C9H16O2

IUPAC Name:

5-pentyldihydrofuran-2(3H)-one

Test material form:

liquid

Details on test material:

- Name of test material (as cited in study report): 2(2H)-Furanone, Dihydro-5-pentyl; ALDEHYDE C18 SO-CALLED
- Physical state: Colourless to slight yellowish
- Date received: 16 August 1999
- Storage condition of test material: Cool and dry
- Stability: At least 1 year

Specific details on test material used for the study:

- Storage condition of test material: Approximately 4 °C in the dark
- Physical state: Colourless slightly viscous liquid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Charles River, Deutschland GmbH, Kißlegg, Germany
- Weight at study initiation: 2.1-2.3 kg
- Housing: Animals were housed individually in PPO cages with perforated floor
- Diet: Pelleted complete rabbit diet "Altromin 2123" (Altromin, Lage, Germany), ad libitum
- Water: Domestic quality drinking water acidified with hydrochloric acid to pH 2.5, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3 °C
- Humidity: 55 ± 15 %
- Air changes: 10/h
- Photoperiod: 12 h dark / 12 h light

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): Undiluted

Duration of treatment / exposure:

24 h

Observation period (in vivo):

72 h

Number of animals or in vitro replicates:

4 females

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: After the first 24 h reading fluorescein was instilled. After rinsing with 20 mL 0.9% sodium chloride solution, the eyes were examined again using UV -light to detect possible corneal damage.

SCORING SYSTEM: Draize (1977) scoring system

TOOL USED TO ASSESS SCORE: Eyes of the animals were examined with a hand held inspection lamp fitted with white and UV -light and magnifying glass with 2 X magnifications. The examination was performed before and after instillation of fluorescein.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

4 animals

Time point:

other: Average 24, 48 and 72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

4 animals

Time point:

other: Average 24, 48 and 72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

4 animals

Time point:

other: Average 24, 48 and 72 h

Score:

0.17

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

4 animals

Time point:

other: Average 24, 48 and 72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

- One hour after application of the test article, 2 animals showed some conjunctival vessels definitely injected, some swelling above normal and some amount of discharge different from normal. Diffuse, crimson red conjunctiva with individual vessels not easily discernible and some swelling above normal was seen in one animal. One animal showed some conjunctival vessels definitely injected and some amount of discharge different from normal.
- After 24 h, 2 animals showed some conjunctival vessels definitely injected. Remaining 2 animals were free of any signs of eye irritation.
- After 48 and 72 h all animals were free of any signs of eye irritation.

Other effects:

No data

Any other information on results incl. tables

Table 7.3.2/1: Scores for ocular lesions

Rabbit no./ Body weight (kg)	Region of eye	Scores
		1 h	24 h	48 h	72 h	Individual mean score
1546 / 2.1	Corneal opacity	0	0	0	0	0
	Iris	0	0	0	0	0
	Conjunctivae: Redness	1	1	0	0	0.33
	Conjunctivae: Chemosis	1	0	0	0	0
1550 / 2.2	Corneal opacity	0	0	0	0	0
	Iris	0	0	0	0	0
	Conjunctivae: Redness	2	0	0	0	0
	Conjunctivae: Chemosis	1	0	0	0	0
1552 / 2.3	Corneal opacity	0	0	0	0	0
	Iris	0	0	0	0	0
	Conjunctivae: Redness	1	1	0	0	0.33
	Conjunctivae: Chemosis	1	0	0	0	0
1566 / 2.2	Corneal opacity	0	0	0	0	0
	Iris	0	0	0	0	0
	Conjunctivae: Redness	1	0	0	0	0
	Conjunctivae: Chemosis	0	0	0	0	0

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, γ-Nonalactone is not classified as irritating to eyes according to the Directive 67/548/EEC and the Regulation (EC) No 1272/2008 (CLP).

Executive summary:

In an eye irritation study conducted according to the OECD Guideline 405 and in compliance with GLP, 4 healthy female rabbits of the New Zealand White strain were exposed to 0.1 mL of γ-Nonalactone in their left eye, while the right eye remained untreated and served as control. The eyelids were then gently held together for 1 second to avoid any loss of the test material. Eyes were examined 1 and 24 h after the instillation of test material. After the 24 h reading, fluorescein was instilled. After rinsing with 20 mL 0.9 % sodium chloride solution, the eyes were examined again using UV-light to detect possible corneal damage. Eyes were also examined 48 and 72 h after the treatment. Ocular reactions were graded according to the method of Draize (1977).

One hour after application of the test material, all animals showed some conjunctival redness, chemosis and discharge different from normal. After 24 h, two animals showed some conjunctival vessels definitely injected. After 48 and 72 h all animals were free of any signs of eye irritation. The calculated mean scores for each individual lesions for all animal within three scoring times (24, 48 and 72 h) were as follow: 0.00 for cornea score; 0.00 for iris score; 0.17 for conjunctivae score and 0.00 for chemosis score, respectively. In this study, γ-Nonalactone is not an eye irritant on female rabbits.

Under the test conditions, γ-Nonalactone is not classified as irritating to eyes according to the Directive 67/548/EEC and the Regulation (EC) No 1272-2008 (CLP).

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

γ-Nonalactone, as aliphatic γ-lactone, is considered adequate for read-across purpose (see §"Toxicokinetics").