3,5-DIMETHOXY-4-(1-METHYLPROPOXY)BENZALDEHYDE

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

27 January 2004 to 06 February 2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: guideline study under GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4-(butan-2-yloxy)-3,5-dimethoxybenzaldehyde

EC Number:

607-081-7

Cas Number:

224586-49-6

Molecular formula:

C13H18O4

IUPAC Name:

4-(butan-2-yloxy)-3,5-dimethoxybenzaldehyde

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): v175023
- Physical state: brown liquid
- Analytical purity: 99.05%
- Lot/batch No.: v175023/P8B
- Expiration date of the lot/batch: 15 Dec 2004
- Storage condition of test material: at room temperature protected from light

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 1834 to 2747 g
- Housing: individual in cages with perforated floors (56X44X37.5 cm)
- Diet: ca 100 g/ day, Charles River breeding and Maintenance Diet for Rabbits (Altromin, Lage, Germany)
- Water: tap water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17.4-23.3 °C
- Humidity (%): 40-77 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied : 0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3 males

Details on study design:

TEST SITE
- Area of exposure: 2X3 cm cm
- Type of wrap if used: semi-occlusive, metaline patch wrapped with micropore tape secured with elastic bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes with water/ethanol
- Time after start of exposure: after 4 hours (at removal of the dressing)

SCORING SYSTEM: Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24-72 h

Score:

0.44

Max. score:

2

Reversibility:

fully reversible

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24-72 h

Score:

0.11

Max. score:

1

Reversibility:

fully reversible

Other effects:

No effects on mortality, clinical signs and body weight

Any other information on results incl. tables

Individual scores

animal	1		2		3
	erythema	oedema	erythema	oedema	erythema	oedema
0 h	2	1	1	1	1	1
24 h	1	1	1	0	1	0
48 h	1	0	0	0	0	0
72 h	0	0	0	0	0	0

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The substance is not irritating to the skin

Executive summary:

Three male rabbits were exposed to the substance (0.5 mL) during 4 hours under a semi-occlusive dressing. Only limited and reversible signs of irritation (oedema and erythema) were seen. The substance is not irritating to the skin.