Methoxycarbonyloxycyclooct-4-ene

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

August 05 - 12, 1985

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

not in compliance with GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

no

Remarks:

Study performed around/just before the time GLP was introduced in Europe, but internal QA statement.

Test material

Test material information

Constituent 1

Reference substance name:

Methoxycarbonyloxycyclooct-4-ene

EC Number:

401-620-8

EC Name:

Methoxycarbonyloxycyclooct-4-ene

Cas Number:

87731-18-8

Molecular formula:

C10H16O3

IUPAC Name:

(1R,3aS,6aS)-octahydropentalen-1-yl methyl carbonate; (1S,3aS,6aS)-octahydropentalen-1-yl methyl carbonate; (3Z)-cyclooct-3-en-1-yl methyl carbonate; (4Z)-cyclooct-4-en-1-yl methyl carbonate; bicyclo[3.2.1]octan-8-yl methyl carbonate

Test material form:

liquid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Rosemead Rabbits, Rosemead, Essex, UK
- Age at study initiation: 9 to 11 weeks
- Weight at study initiation: 2.0 to 2.6 kg
- Housing: individually housed in metal cages with perforated floors
- Diet: free access to SDS Standard Rabbit Diet
- Water: free access to tap water
- Acclimation period: no data available

ENVIRONMENTAL CONDITIONS
- Temperature (°C): approximately 19
- Humidity (%): 30 - 70
- Air changes (per hr): approximately 19
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The contralateral eye remained untreated and served as a control.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.1 mL

Duration of treatment / exposure:

One single application

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

1 female, 2 males

Details on study design:

TREATMENT
The test substance was placed into the lower everted lid of one eye of each animal. The eyelids were then gently held together for one second before releasing.

REMOVAL OF TEST SUBSTANCE
- Washing: No

SCORING SYSTEM:
Observation of the eyes was aided by the use of a handheld torch. The irritation was assessed according to OECD 405. Any other lesion not covered by the scoring system, will be described. Examination 1 hour, 1, 2, 3, 4 and 7 days after application.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

other: All animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

other: All animals

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

other: All animals

Time point:

24/48/72 h

Score:

0.67

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Results 4

Irritation parameter:

chemosis score

Basis:

other: All animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

No corneal damage or iridial inflammation was observed.
A diffuse crimson red colouration of the conjunctivae was observed in all three animals at the 1 hour reading only. Slight conjunctival inflammation was observed on the following two days. All eyes were normal three days after instillation.

Applicant's summary and conclusion

Interpretation of results:

other: Not an eye irritant in accordance with EU CLP (EC no. 1272/2008 and its amendments)

Conclusions:

The substance is not an eye irritant in the in vivo eye irritation test (OECD TG 405).

Executive summary:

The substance was tested in an in vivo acute eye irritation study (OECD TG 405). Three female rabbits were exposed to the substance for a duration of 1 hour using a single application of 0.1 mL. The treatment was followed by an observation period of 14 days. No corneal damage or iridial inflammation was observed. Conjunctival inflammation was observed in all three animals, but eyes had returned to normal three days after instillation. Average scores for conjunctival irritation (redness) were 0.67 for all animals over the 24/48/72 -hour observations. Iris, opacity and chemosis scores were 0 for all animals over the entire observation period. Based on these results, the substance is not an eye irritant.