Propyl 4-hydroxybenzoate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

.

Justification for type of information:

see read-acorss justification attached in chapter 13.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Ethyl 4-hydroxybenzoate

EC Number:

204-399-4

EC Name:

Ethyl 4-hydroxybenzoate

Cas Number:

120-47-8

Molecular formula:

C9H10O3

IUPAC Name:

ethyl 4-hydroxybenzoate

Details on test material:

- Name of test material (as cited in study report): Solbrol A
- Physical state: solid
- Analytical purity: no data

Test animals

Species:

rabbit

Strain:

other: HC:NWZ

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hacking & Churchill Ltd., Huntingdon, UK
- Weight at study initiation: 3500 g
- Housing: Animals were housed individually
- Diet: ssniff K, ad libitum
- Water: tap water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 40 - 60
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: Not required, the untreated sites of the same animal served as control.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 g test substance, moistened with water

Duration of treatment / exposure:

4 h

Observation period:

7 d
reading time points: 1, 24, 48, 72 h and 7 d

Number of animals:

3 males

Details on study design:

TEST SITE
- Area of exposure: approximately 6 cm² on the back of the animal
- Type of wrap if used: The test substance was applied to a gauze patch, held in place by elastic tape that was permeable to air.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated skin sites were washed with water.
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

out of all 3 animals

Time point:

24/48/72 h

Score:

0

Reversibility:

other: reversibility: not applicable

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

out of all 3 animals

Time point:

24/48/72 h

Score:

0

Reversibility:

other: reversibility: not applicable

Irritant / corrosive response data:

Dermal application of the test substance did not result in erythema or edema in any of the animals tested at any observation time point.

Other effects:

no data on body weight and clinical observations

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified