Reaction mass of (3aR,5aS,9aS,9bR)-3a,6,6,9a-Tetramethyldodecahydronaphtho[2,1-b]furan and (3aS,5aR,9aR,9bS)-3a,6,6,9a-Tetramethyldodecahydronaphtho[2,1-b]furan

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 1989-02-10 to 1989-02-21

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Study performed according to OECD test guideline No. 405 and in compliance with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

[3aR-(3aα,5aβ,9aα,9bβ)]-dodecahydro-3a,6,6,9a-tetramethylnaphtho[2,1-b]furan

EC Number:

229-861-2

EC Name:

[3aR-(3aα,5aβ,9aα,9bβ)]-dodecahydro-3a,6,6,9a-tetramethylnaphtho[2,1-b]furan

Cas Number:

6790-58-5

Molecular formula:

C16H28O

IUPAC Name:

(3aR,5aS,9aS,9bR)-3a,6,6,9a-Tetramethyldodecahydronaphtho[2,1-b]furan

Constituent 2

Reference substance name:

(3aS,5aR,9aR,9bS)-3a,6,6,9a-Tetramethyldodecahydronaphtho[2,1-b]furan

Cas Number:

234431-64-2

Molecular formula:

C16H28O

IUPAC Name:

(3aS,5aR,9aR,9bS)-3a,6,6,9a-Tetramethyldodecahydronaphtho[2,1-b]furan

Constituent 3

Reference substance name:

(3aR,5aS,9aS,9bS)-3a,6,6,9a-tetramethyldodecahydronaphtho[2,1-b]furan

Cas Number:

68365-89-9

Molecular formula:

C16H28O

IUPAC Name:

(3aR,5aS,9aS,9bS)-3a,6,6,9a-tetramethyldodecahydronaphtho[2,1-b]furan

Constituent 4

Reference substance name:

(3aS,5aR,9aR,9bR)-Dodecahydro-3a,6,6,9a-tetramethylnaphtho[2,1-b]furan

Cas Number:

2006270-65-9

Molecular formula:

C16H28O

IUPAC Name:

(3aS,5aR,9aR,9bR)-Dodecahydro-3a,6,6,9a-tetramethylnaphtho[2,1-b]furan

Test material form:

solid

Details on test material:

- Physical state: pale yellow liquid or white solid
- Stability under test conditions: stable

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, Fuellinsdorf, Switzerland
- Age at study initiation: M: 15 weeks; F: 16 weeks
- Weight at study initiation: M: 2.7 kg; F: 2.6-2.9 kg
- Housing: individually in stainless steel cages
- Diet (e.g. ad libitum): Pelleted standard Kliba 341, Batch 42/88 rabbit maintenance diet ad libitum
- Water (e.g. ad libitum): community tap water from Itingen ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 +/- 3 °C
- Humidity (%): 40-70 %
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From:1989-02-10 To: 1989-02-21

Test system

Vehicle:

other: undiluted or in Neantine

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Left eye: 0.1 g (undiluted) / Right eye: 0.1 mL (diluted into 30 % in Neantine)

Duration of treatment / exposure:

Eyes were not rinsed

Observation period (in vivo):

Eyes were observed 1, 24, 48, 72 hours and 7 days after administration

Number of animals or in vitro replicates:

1 male and 2 females

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not done
- Time after start of exposure:

SCORING SYSTEM: Draize scale according to the OECD test guideline No. 405

TOOL USED TO ASSESS SCORE: slit-lamp and diagnostic-lamp

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: #1, #2 and #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

animal: #1, #2 and #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal: #1 and #2

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:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.67

Max. score:

3

Reversibility:

fully reversible within: 7 days

Remarks on result:

probability of weak irritation

Results 5

Irritation parameter:

chemosis score

Basis:

animal: #1 and #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

probability of weak irritation

Irritant / corrosive response data:

See Table 7.3.2/1

Other effects:

none

Any other information on results incl. tables

Table 7.3.2/1: Mean irritant/corrosive response data of each animal at each observation time up to removal from the test

 

Score at time point / Reversibility	Cornea opacity(/4)	Iris (/2)	Conjunctivae
			Redness (/3)	Chemosis (/4)
1 h	0/0/0	0/0/0	2/2/2	1/0/1
24 h	0/0/0	0/0/0	1/1/2	0/0/1
48 h	0/0/0	0/0/0	0/0/2	0/0/1
72 h	0/0/0	0/0/0	0/0/1	0/0/0
Mean 24-48-72 hrs	0.0/0.0/0.0	0.0/0.0/0.0	0.33/0.33/1.67	0.00/0.00/0.67
Reversibility*)	-	-	c.	c.
Average time (unit) for reversion			7 days	72 hours

*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions, the test material is not classified as irritating to eyes according to the criteria of the Regulation (EC) No 1272/2008 (CLP) and to the GHS.

Executive summary:

In an eye irritation study performed according to the OECD guideline No. 405, and in compliance with GLP, 0.1 g of undiluted Fixambrene was instilled into the left eye of 3 New Zealand White Rabbit. The eyes were not rinsed after the instillation of the test item.The left eye of each rabbit was instilled with 0.1 mL Fixambrene diluted at 30 % in Neantine. Animals were observed at 1, 24, 48 and 72 hours after dosing under a standard light source. The reactions in the conjunctiva (redness, chemosis and discharge), the iris and the cornea (opacity and area involved) were scored according to the Draize scale. 

 

The calculated mean score for each individual lesion for each animal treated with undiluted Fixambrene within 3 scoring times (24, 48 and 72 h) were as follows: 0.0/0.0/0.67 for chemosis; 0.33/0.33/1.67 for redness; 0.0/0.0/0.0 for iris and corneal lesions.

The effects observed were all reversible within 7 days.

 

Under the test conditions, Fixambrene is not classified as irritating to eyes according to the criteria of the Regulation (EC) No 1272/2008 (CLP) and to the GHS.

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