Benzoic acid, 4-hydroxy-, 1,1'-(1,4-phenylene) ester

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1996-11-20 until 1997-02-24

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study followed OECD Guideline under GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Hydroquinone-bis-p-hydroxybenzoate (OH-Dreikerner)

IUPAC Name:

Hydroquinone-bis-p-hydroxybenzoate (OH-Dreikerner)

Details on test material:

- Name of test material (as cited in study report): Hydroquinone-bis-p-hydroxybenzoate (OH-Dreikerner)
- Physical state: solid
- Analytical purity: >95%
- Stability under test conditions: stable in water for at least 24 h
- Storage condition of test material: in original container, at room temperature, in the dark

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Broekmann Institute, Someren, Netherlands
- Weight at study initiation: 1.3-1.5 kg
- Age: Approx. 7 weeks old
- Housing: Individually in cages; air-conditioned room
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 °C
- Humidity (%): 50 % rel. humidity
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12 h dark, 12 h light

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

other: same animal, adjacent areas

Amount / concentration applied:

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

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3 males

Details on study design:

TEST SITE
- Area of exposure: 2 cm * 3 cm
- Type of wrap if used: Sctchpak non woven patch


REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4 hours


SCORING SYSTEM: as stated in Guideline OECD 404

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

animal: 1-3

Time point:

other: any

Score:

0

Max. score:

0

Remarks on result:

other: no irritant effects in any animal

Results 2

Irritation parameter:

erythema score

Basis:

animal: 1-3

Time point:

other: any

Score:

0

Max. score:

0

Remarks on result:

other: no irritant effects in any animal

Results 3

Irritation parameter:

edema score

Basis:

animal: 1-3

Time point:

other: any

Score:

0

Max. score:

0

Remarks on result:

other: no irritant effects in any animal

Other effects:

no

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Substance is not irritating to the skin of rabbits under the conditions of the test

Executive summary:

Hydroquinone-bis-p-hydroxybenzoate (OH-Dreikerner) was investigated for skin irritating potential according to OECD Guideline 404 under GLP. Three rabbits were exposed to 0.5 g Hydroquinone-bis-p-hydroxybenzoate (OH-Dreikerner), applied onto clipped skin for 4 hours using a semi-occlusive dressing. Observations were made 1, 24, 48 and 72 hours after exposure.

No skin irritation was caused by 4 hours exposure to Hydroquinone-bis-p-hydroxybenzoate (OH-Dreikerner). According to the EEC criteria for classification and labelling requirements Hydroquinone-bis-p-hydroxybenzoate (OH-Dreikerner) does not have to be classified and has no obligatory labelling requirement.