2-bromo-5-hydroxy-4-methoxybenzaldehyde

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1997-12-03 to 1998-12-18

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Study followed Method B4 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC) and OECD Guildelines 404.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Good Laboratory Practice (GLP) in Switzerland, Procedures and Principles, March 1986.

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

426-540-0

EC Name:

-

Cas Number:

2973-59-3

Molecular formula:

C8 H7 Br O3

IUPAC Name:

2-bromo-5-hydroxy-4-methoxybenzaldehyde

Test material form:

solid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 002 65786
- Expiration date of the lot/batch: 1998-07-01
- Purity test date: no data

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature (ca. 20 deg C) away from direct sunlight
- Stability under test conditions: no data
- Solubility and stability of the test substance in the solvent/vehicle: not specified; excluded from the Statement of Compliance

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: As a solid, approximately 0.5 g (per animal) of test item was weighed and then moistened with bidistilled water before application. Prior to the application the pH of the test item was determined with pH-Test Strip (E. Merck, D-64271 Darmstadt, Germany) and was found not be assessable.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Birkendorferstrasse 65, D-88397 Biberach/Riss
- Age at study initiation: 15 weeks
- Weight at study initiation: 2765-3255 g
- Housing: Individually in stainless steel cages with an automatic cleaning system equipped with feed hoppers, drinking water bowls and wood for gnawing.
- Diet (e.g. ad libitum): pelleted standard Kliba 3410 rabbit maintenance diet batch 78/97, ad libitum
- Water (e.g. ad libitum): Itingen community tap water, ad libitum
- Acclimation period: 4 days


ENVIRONMENTAL CONDITIONS
- Temperature (deg C): 20 +/- 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12, with music played approximately 8 hours during light cycle


IN-LIFE DATES: From: 1997-12-03 To: 1997-12-18

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

other: bidistilled water

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g per animal


VEHICLE
- Amount(s) applied (volume or weight with unit): bi-distilled water, enough to moisten the test item

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48, and 72 hours after administration

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: dorsal area
- % coverage: Approximately 6 cm² of the intact skin of the clipped area was covered with 0.5 g moistened test item.
- Type of wrap if used: A 2.5 x 2.5 cm patch of surgical gauze was placed on top, and covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and secured with tape.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): The dressing was removed, and the skin flushed with lukewarm tap water.
- Time after start of exposure: 4 hours


SCORING SYSTEM:
Per EEC Commission Directive 92/69 EEC, July 31, 1992

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritant / corrosive response data:

No staining by the test item of the treated skin was observed.
No irreversible alterations of the treated skin were observed nor were corrosive effects evident on the skin.

Other effects:

The body weights of all rabbits were within the normal range.
No signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality occurred.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of this study, the test item was considered to be non-irritating to rabbit skin.