[3aR-(3aα,5aβ,9aα,9bβ)]-dodecahydro-3a,6,6,9a-tetramethylnaphtho[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 September 22 to October 13, 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

GLP study conducted according to the original OECD Guideline 405 (1987).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

(Adopted February 24, 1987)

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-tetramethyl-dodecahydronaphtho[2,1-b]furan

Test material form:

solid

Details on test material:

- Name of test material (as cited in study report): 8α,-11-Oxido-13,14,15,16-tetranorlabdan / Ambroxan
- Physical state: white solid
- Stability under test conditions: stable for at least 2 years
- Storage condition of test material: cool and dark

Test animals / tissue source

Species:

rabbit

Strain:

other: Kleinrussen, Chbb:HM

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Thomae GmbH, D-Biberach
- Age at study initiation: approximately 20 months
- Weight at study initiation: approximately 2470 g
- Housing: individual accommodation
- Diet: Ssniff rabbit diet K4 ad libitum (Ssniff GmbH, D-Soest)
- Water: tap water ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 45-70
- Air changes (per hr): at least 8
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: September 22, 1992 To: October 13, 1992

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye 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):

1, 24, 48, 75 hours after instillation, then on Days 7and 14.

Number of animals or in vitro replicates:

3 males

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with tepid tap water
- Time after start of exposure: 24 hours

SCORING SYSTEM: Draize scale as described in the OECD guideline No. 405.

TOOL USED TO ASSESS SCORE: slit lamp microscope

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, #2 and #3

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 14 days

Remarks on result:

probability of weak irritation

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Remarks on result:

probability of weak irritation

Results 5

Irritation parameter:

chemosis score

Basis:

animal: #2 and #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

The observed conjunctival reactions of the experimental animals were weak and disappeared completely within 14 days.

Other effects:

None

Any other information on results incl. tables

Table 7.3.2/1: Irritant/corrosive response data each animals at each observation time up to removal from the test

 

Score at time point / Reversibility	Cornea	Iris (/2)	Conjunctivae
	Opacity (/4)		Redness (/3)	Chemosis (/4)	Discharge (/3)
1 h	0 / 0 / 0	0 / 0 / 0	1 / 1 / 2	1 / 1 / 1	0 / 1 / 0
24 h	0 / 0 / 0	0 / 0 / 0	1 / 1 / 1	1 / 0 / 0	0 / 0 / 0
48 h	0 / 0 / 0	0 / 0 / 0	1 / 1 / 1	0 / 0 / 0	0 / 0 / 0
72 h	0 / 0 / 0	0 / 0 / 0	1 / 1 / 1	0 / 0 / 0	0 / 0 / 0
Average 24h, 48h, 72h	0 / 0 / 0	0 / 0 / 0	1.0 / 1.0 / 1.0	0.33 / 0.0 / 0.0	0 / 0 / 0
Reversibility*)	-	-	c.	c.	-
Average time for reversion	-	-	14 days	48 h	-

*) 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 induced weak to mild irritation being reversible within 14 days. Therefore the test material is not classified as irritant to the eyes according to the criteria of the Annex I of the Regulation (EC) No. 1272/2008 (CLP).

Executive summary:

In an eye irritation study performed according to the OECD guideline No. 405, and in compliance with GLP, 0.1 mL of undiluted test material was instilled into the right eye of 3 Kleinrussen (Chbb: HM) rabbits. The eyes were rinsed 24 hours after the instillation of the test item. The left eye of each rabbit served as control. Animals were observed at 1, 24, 48 and 72 hours after dosing under a standard light source, and then on Days 7 and 14. 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 observed conjunctival reactions of the experimental animals were weak and disappeared completely within 14 days. 

 

The individual score for each individual lesion for each animal within 3 scoring times (24, 48 and 72 hrs) were 1.00/1.00/1.00 for erythema, 0.33/0.00/0.00 for chemosis and 0.00 for discharge, iris lesions and corneal opacity.

 

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

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