Toluene-4-sulphonic acid

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Study period:

July 5-19, 1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline not specified, but with detailed documentation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

no guideline followed

Guideline:

other: no information about guideline provided

Deviations:

not specified

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

ammonium xylene sulfonate

IUPAC Name:

ammonium xylene sulfonate

Details on test material:

- Name of test material (as cited in study report): ammonium xylene sulfonate (AXS)
- Molecular formula (if other than submission substance): no data
- Molecular weight (if other than submission substance): no data
- Substance type:
- Physical state: liquid
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: no data
- Lot/batch No.: 8694K
- Expiration date of the lot/batch: no data
- Stability under test conditions: stable
- Storage condition of test material: no data
- Other: specific gravity = 1.121 at 25 degrees Centigrade

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Boswell
- Age at study initiation: young adult
- Weight at study initiation: 2.50-2.98 kilograms
- Fasting period before study: no data
- Housing:individually in metal cages elevated above droppings
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 14 days minimum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr):no data
- Photoperiod (hrs dark / hrs light): no data


IN-LIFE DATES: From: July 5, 1979 To:July 19, 1979

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: trunk
- % coverage: no data
- Type of wrap if used: plastic binder with adhesive tape
- Other: Prior to exposure, the trunks of the animals were clipped free of hair and the skin examined. Only those animals without skin defects or irritation were used for the study. The skin was further prepared by making epidermal abrasions every two or three centimeters longitudinally over the area of exposure. The abrasions were sufficiently deep to penetrate the stratm corneum but not deep enough to disturb the derma.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped with absorbent paper towel
- Time after start of exposure: 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): no data other than enough to cover the treatment site
- Concentration (if solution): undiluted
- Constant volume or concentration used: yes


VEHICLE
- Amount(s) applied (volume or weight with unit): no vehicle

Duration of exposure:

24 hours

Doses:

0.5 and 2.0 g /kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations on day of dosage and daily (5 days per week) for 14 days; weighing on day of dosage and 7 days post treatment
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs including erythema, edema, thickening, dryness, desquamation, papules

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortalities occurred in the study

Clinical signs:

At 24 hours all animals showed a moderate erythema and a minimal to moderate edema at the treatment site. This initial dermal reaction was followed by the usual sequelae of redness, thickening, dryness and desquamation, which persisted in varying degrees through 14 days. No gross signs of test compound induced adverse systemic toxicity were observed in any of the animals following application or during the 14 day observation period.

Body weight:

Body weight records showed a normal weight picture for each of the animals at 7 and 14 days post-treatment. 13 of the 20 animals showed >10% weight gain in 13 days and none showed any weight loss.

Gross pathology:

Two animals (a male at 0.5 g/kg bw and a male at 2.0 g/kg bw) had wrinkling and fissuring of the cortex of both kidneys. All other organs and tissues were not remarkable.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The dermal LD50 on male and female rabbits is greater than 2000 mg/kg body weight.