Methoxycyclododecane

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

01-09 Nov 1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

Feb 1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Version / remarks:

Jan 1997

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Methoxycyclododecane

EC Number:

221-053-8

EC Name:

Methoxycyclododecane

Cas Number:

2986-54-1

Molecular formula:

C13H26O

IUPAC Name:

methoxycyclododecane

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: 2.4 - 3.0 kg
- Housing: during a pre-period of at least one week and throughout the experiment the rabbits were caged individually in PPO cages (floor area: 2576 cm²) with perforated floor.
- Diet: Altromin 2123, Lage, Lippe, Germany, ad libitum
- Water: ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The right eye remained untreated and served as control

Amount / concentration applied:

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

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

Reading time points: 1, 24, 48, 72 hours and 7 days after treatment

Number of animals or in vitro replicates:

4 females

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, the treated eye was rinsed with 20 mL 0.9% sodium chloride solution
- Time after start of exposure: 24 hours

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of 4 animals

Time point:

other: mean after 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

of 4 animals

Time point:

other: mean after 24, 48 and 72 h

Score:

0

Max. score:

2

Reversibility:

other: reversibility: not applicable

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

of 4 animals

Time point:

other: mean after 24, 48 and 72 h

Score:

1.3

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of 4 animals

Time point:

other: mean after 24, 48 and 72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritant / corrosive response data:

One hour after application of the test material one animal showed some conjunctival vessels definitely injected, some swelling above normal and discharge with moistening of the lids and hairs just adjacent to lids. A diffuse, crimson red conjunctiva, individual vessels were not easily discernible, obvious swelling with partial eversion of lids and discharge with moistening of the lids and hairsjust adjacent to lids were seen in three animals.
After 24 and 48 hours 2 animals showed some conjunctival vessels definitely injected. A diffuse, crimson red conjunctiva, individual vessels were not easily discernible, and some swelling above normal were observed in 2 animals.
After 72 hours all animals showed some conjunctival vessels definitely injected.
On Day 7 after application of the test material all animals were free of any signs of eye irritation.

Any other information on results incl. tables

Table: Scores for ocular lesions

Rabbit #	Time	conjunctivae		iris	cornea
		redness	swelling
1	1 h	1	1	0	0
	24 h	1	0	0	0
	48 h	1	0	0	0
	72 h	1	0	0	0
	7 d	0	0	0	0
	average	1.0	0.0	0.0	0.0
2	1 h	2	2	0	0
	24 h	1	0	0	0
	48 h	1	0	0	0
	72 h	1	0	0	0
	7 d	0	0	0	0
	average	1.0	0.0	0.0	0.0
3	1 h	2	2	0	0
	24 h	2	1	0	0
	48 h	2	1	0	0
	72 h	1	0	0	0
	7 d	0	0	0	0
	average	1.67	0.67	0.0	0.0
4	1 h	2	2	0	0
	24 h	2	1	0	0
	48 h	2	1	0	0
	72 h	1	0	0	0
	7 d	0	0	0	0
	average	1.67	0.67	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:

Based on the mean scores over 24, 48 and 72 h for conjunctival erythema, chemosis, cornea and iris determined after single ocular instillation of the neat test substance to 4 female rabbits, the test substance is not expected to be irritating to the eye.