4-(4-Allyloxy-benzenesulfonyl)-phenol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

17 June to 01 July 2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study undertaken at GLP accredited laboratory to internationally accepted guidelines.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

BPS-MAE

IUPAC Name:

BPS-MAE

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): BPS-MAE
- Physical state: White powder
- Lot/batch No.: G140421
- Storage condition of test material: Room temperature in the dark.
- Other: Date received 19 may 2004

Test animals

Species:

rat

Strain:

other: Sprague-Dawley CD (Cd: CD® (SD) IGS BR)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Commercial laboratory animal supplier.
- Age at study initiation: 8 to 12 weeks
- Weight at study initiation: >= 200g
- Fasting period before study: No
- Housing: The animals were housed in suspended solid-floor polypropylene cages furnished with woodflakes.
- Diet: Free access to food (Certified Rat and Mouse Diet (Code 5LF2) supplied by BCM IPS Limited, London, UK) was allowed throughout the study.
- Water: Free access to mains drinking water was allowed throughout the study.
- Acclimation period: >= 5 days

ENVIRONMENTAL CONDITIONS
- Temperature): 19 to 25°C
- Humidity: 30 to 70%
- Air changes: The rate of air exchange was at least fifteen changes per hour
- Photoperiod: The lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

arachis oil

Details on dermal exposure:

TEST SITE
- Area of exposure:
- % coverage: 10
- Type of wrap if used: A piece of surgical gauze was placed over the treatment area and semi-occluded with a piece of self-adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treated skin and surrounding hair wiped with cotton wool moistened with arachis oil BP to remove any residual
test material.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount applied 10 ml/kg
- Concentration: 200 mg/ml
- For solids, paste formed: no

VEHICLE
- Amount applied: No data

Duration of exposure:

24 h

Doses:

One

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 1/2 hour, 1 hour, 2 hours, 4 hours and 14 days
- Frequency of observations and weighing: At 0, 7 and 14 days.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,rgan weights, histopathology. All animals were subjected to gross necropsy. This consisted of an external examination and opening of the abdominal and thoracic cavities.

Results and discussion

Preliminary study:

No study undertaken

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0

Clinical signs:

Signs of toxicity related to dose levels: There were no signs of systemic toxicity throughout the study.

Body weight:

All animals showed expected gains in bodyweight over the study period.

Gross pathology:

Effects on organs: No abnormalities were noted at macroscopic examination at study termination.

Other findings:

Signs of toxicity (local): There were no deaths and no clinical signs of dermal irritation.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute dennal median lethal dose (LD50) ofthe test material in the Sprague-Dawley CD strain rat was found to be greater than 2000 mgIkg bodyweight.