1-(3,5-dihydroxyphenyl)-2-[[2-(4-hydroxyphenyl)-1-methylethyl]amino]ethan-1-one hydrobromide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

29 November 1999 to 03 December

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1992

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

Directive 92/69

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Version / remarks:

1996

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

1-(3,5-dihydroxyphenyl)-2-[[2-(4-hydroxyphenyl)-1-methylethyl]amino]ethan-1-one hydrobromide

EC Number:

222-148-7

EC Name:

1-(3,5-dihydroxyphenyl)-2-[[2-(4-hydroxyphenyl)-1-methylethyl]amino]ethan-1-one hydrobromide

Cas Number:

3371-33-3

Molecular formula:

C17H19NO4.BrH

IUPAC Name:

1-(3,5-dihydroxyphenyl)-2-{[1-(4-hydroxyphenyl)propan-2-yl]amino}ethan-1-one hydrobromide

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: No details on the source of the test material were provided. Batch number: 206.
- Expiration date of the lot/batch: No details reported.
- Purity test date: 15 June 1999.

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature, protected from light.
- Stability under test conditions:Not reported
- Solubility and stability of the test substance in the solvent/vehicle: No details reported.

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test substance was moistened with water to ensure good contact with the site of administration.
- Preliminary purification step (if any):No details reported.
- Final dilution of a dissolved solid, stock liquid or gel:No details reported.
- Final preparation of a solid:No details reported.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Animals: 3 female New Zealand White rabbits
- Housing: individually housed in ABS - plastic rabbit cages, floor 4200 cm2, Semi-barrier in air conditioned rooms.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: adequate acclimatization period. No further details reported.

ENVIRONMENTAL CONDITIONS
- Temperature: 18 +/- 3°C
- Humidity: 55 +/- 10%
- Air changes: at least 10 per hour
- Photoperiod (hrs dark / hrs light): 12 hours dak/12 hours artificial light

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

yes, concurrent no treatment

Amount / concentration applied:

A dose of 0.5 g of the test item was applied to each test site.

Duration of treatment / exposure:

4 hour

Observation period:

1, 24, 48, 72 hours after patch removal

Number of animals:

3 (female)

Details on study design:

TEST SITE
- Area of exposure: 6 cm² of skin on one side of the dorsal area of the animals.
- Type of wrap if used: gauze patch, non-irritating tape

Evaluation of results
- according to the relevant OECD test guideline

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 1/24/48/72 h

Score:

0

Max. score:

4

Reversibility:

not specified

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 1/24/48/72 h

Score:

0

Max. score:

4

Reversibility:

not specified

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 1/24/48/72 h

Score:

0

Max. score:

4

Reversibility:

not specified

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 1/24/48/72 h

Score:

0

Max. score:

4

Reversibility:

not specified

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 1/24/48/72 h

Score:

0

Max. score:

4

Reversibility:

not specified

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: 1/24/48/72 h

Score:

0

Max. score:

4

Reversibility:

not specified

Irritant / corrosive response data:

The test substance showed no irritant/corrosive effects.

Any other information on results incl. tables

The test substance showed no irritant effects on the intact skin after a contact time of 4 hours.

No skin reactions (erythema, oedema) were recorded throughout the observation period of 72 hours as compared to untreated control sites. There were no significant body weight changes during the contact and observation period.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance showed no irritant effects on the intact skin after a contact time of 4 hours. Based on the results of this study, the test substance is classified as not skin irritating according to CLP criteria.