2-bromo-5-hydroxy-4-methoxybenzaldehyde

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1997-12-17 to 1997-12-25

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

GLP study performed according to OECD Guideline 405 (Acute Eye Irritation / Corrosion) and EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion) without deviation.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1998

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

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 applicable, test item was applied undiluted

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: as a solid, approximately 01. g (per animal) of the test item was weighed applied as undiluted.
Prior to the application the pH of the test article was determined with pH-Test-Strip (E. Merck, D-64271 Darmstadt / Germany) and was found to be not assessable.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Remarks:

Chbb:NZW(SPF)

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Birkendorferstrasses 65, D-88397 Biberach/Riss
- Age at study initiation: 15 weeks
- Weight at study initiation: 2928-2997 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 batch 78/97 rabbit maintenance diet, 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: 1997-12-17 To: 1997-12-25

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g

Duration of treatment / exposure:

72 hours

Observation period (in vivo):

1, 24, 48, and 72 hours after administration

Number of animals or in vitro replicates:

3

Details on study design:

TEST SITE
-On the day of treatment, the test article (undiluted) was placed in the conjunctival sac of the left eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of test article.

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

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

TOOL USED TO ASSESS SCORE:
- hand-slit lamp, Varta Cliptrix

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

3 eyes

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

3 eyes

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 3

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Remarks:

3 eyes

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 hr

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

3 eyes

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hr

Irritant / corrosive response data:

Application of the test item to healthy rabbit conjunctivae resulted in a primary irritation score of 1.33. Slight to moderate reddening and swelling of the conjunctivae were noted in all animals, as was moderate watery discharge. Hyperemia of the scleral blood vessels was seen in one animal. All signs of irritation were reversible after 72 hours.
No corrosion ofthe cornea was observed at any ofthe reading times.

Other effects:

No clinical signs of systemic toxicity were observed in the animals during the test, and no mortality occurred.
No staining of the cornea, conjunctivae or sclera by the test article was observed.
The body weight of all rabbits were considered to be within the normal range of variability.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this study, the test item was considered to be non-irritating to the rabbit eye.