4-trans-propenylveratrole

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From October 16 to 20, 2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

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 (incl. QA statement)

Remarks:

(inspected on June 14, 1999 / signed on December 01, 1999)

Test material

Test material information

Constituent 1

Reference substance name:

4-trans-propenylveratrole

EC Number:

228-958-7

EC Name:

4-trans-propenylveratrole

Cas Number:

6379-72-2

Molecular formula:

C11H14O2

IUPAC Name:

(E)-1,2-Dimethoxy-4-prop-1-en-1-ylbenzene

Test material form:

liquid

Details on test material:

- Physical state: Yellowish liquid
- Storage condition of test material: 7°C, protected from light and moisture

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, Stolzenseeweg 32-36, 88353 Kißlegg
- Weight at study initiation: 2.5-2.7 kg
- Housing: Animals were housed individually in PPO cages (floor area: 2576 cm2) with perforated floor.
- Diet: Pelleted complete rabbit diet (‘Altromin 2123’ from Altromin, D-32791 Lage, Lippe), ad libitum
- Water: Drinking water, ad libitum
- Acclimation period: 7 days

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

IN-LIFE DATES: From: October 16, 2000 To: October 20, 2000

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 h

Observation period (in vivo):

1, 24, 48 and 72 h after instillation of test material

Number of animals or in vitro replicates:

4 females

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Fluorescein was instilled into eyes of test animals after 24 h reading. Then eyes were rinsed with 20 mL of 0.9 % sodium chloride solution.
- Time after start of exposure: 24 h

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

TOOL USED TO ASSESS SCORE: Eyes (before and after instillation of fluorescein) were examined using hand held inspection lamp fitted with white and UV-light and magnifying glass with 2 x magnification.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: #1, #2, #3 & #4

Time point:

other: Mean 24, 48 and 72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

animal: #1, #2, #3 & #4

Time point:

other: Mean 24, 48 and 72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal: #1 & #4

Time point:

other: Mean 24, 48 and 72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: Mean 24, 48 and 72 h

Score:

0

Max. score:

3

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: Mean 24, 48 and 72 h

Score:

0.67

Max. score:

3

Reversibility:

not fully reversible within: 72 h

Results 6

Irritation parameter:

chemosis score

Basis:

animal: #1, #2, #3 & #4

Time point:

other: Mean 24, 48 and 72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

- 1 h after test material instillation, two animals showed conjunctival vessels definitely injected and a swelling above normal. A diffuse, crimson red conjunctiva with individual vessels not easily discernible as well as a swelling above normal was observed in one animal. One animal showed an iris with markedly deepened folds, congestion swelling, moderate circumcorneal injection and existence of reaction to light, a diffuse, crimson red conjunctiva with individual vessels not easily discernible as well as a swelling above normal was observed.
- 24 h after test material instillation, three animals showed some conjunctival vessels definitely injected. One animal showed no signs of eye irritation.
- 48 h after test material instillation, one animal showed some conjunctival vessels definitely injected. No eye irritation was observed in other animals.
- None of the four animals showed any sign of eye irritation at 72 h.

Other effects:

None

Any other information on results incl. tables

Table 7.3.2/1: Eye irritation response data for each animal at each observation time

Score at time point	Cornea		Iris (/2)	Conjunctivae
	Opacity (/4)	Area (/4)		Redness (/3)	Chemosis (/4)	Discharge (/3)
1 h	0/0/0/0	0/0/0/0	0/0/0/1	1/1/2/2	1/1/1/1	0/0/0/0
24 h	0/0/0/0	0/0/0/0	0/0/0/0	1/0/1/1	0/0/0/0	0/0/0/0
48 h	0/0/0/0	0/0/0/0	0/0/0/0	0/0/1/0	0/0/0/0	0/0/0/0
72 h	0/0/0/0	0/0/0/0	0/0/0/0	0/0/0/0	0/0/0/0	0/0/0/0
Average 24, 48 and 72 h	0/0/0/0	0/0/0/0	0/0/0/0	0.33/0/0.67/0.33	0/0/0/0	0/0/0/0
Reversibility	-	-	Completely reversible	Completely reversible	Completely reversible	-
Average time (unit) for reversion	-	-	24 h	72 h	24 h	-

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 the eyes according to the annex VI 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 mL of undiluted test material was instilled into one eye of 4 female New Zealand White rabbits. The other eye remained untreated and served as control. The upper and lower eyelids were held together for about one second immediately after instillation. The eyes were examined and the changes were observed at 1, 24, 48 and 72 h after treatment and graded according to the Draize method.

1 h after test material instillation, two animals showed conjunctival vessels definitely injected and a swelling above normal. A diffuse, crimson red conjunctiva with individual vessels not easily discernible as well as a swelling above normal was observed in one animal. One animal showed an iris with markedly deepened folds, congestion swelling, moderate circumcorneal injection and existence of reaction to light, a diffuse, crimson red conjunctiva with individual vessels not easily discernible as well as a swelling above normal was observed. 24 h after test material instillation, three animals were observed some conjunctival vessels definitely injected. 48 h after test material instillation, one animal showed some conjunctival vessels definitely injected. None of the four animals showed any sign of eye irritation at 72 h.

The calculated mean score for each animal within 3 scoring times (24, 48 and 72 h) were 0.33/0.0/0.67/0.33 for redness, 0/0/0/0 for chemosis, 0/0/0/0 for iris lesions and 0/0/0/0 for corneal opacity. The effects observed were all reversible within 72 hours.

Under the test conditions, the test material is not classified as irritating to the eyes according to the annex VI 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.