Ammonium (xylenes and 4-ethylbenzene)sulfonates

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

July 5-19, 1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Ammonium (xylenes and 4-ethylbenzene) sulphonate

EC Number:

943-024-5

Molecular formula:

C8H13NO3S

IUPAC Name:

Ammonium (xylenes and 4-ethylbenzene) sulphonate

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 minimumENVIRONMENTAL 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

Vehicle:

unchanged (no vehicle)

Duration of exposure:

24 hours

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

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortalities occurred in the study

Clinical signs:

other: 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

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:

GHS criteria not met

Conclusions:

LD50 is greater than 2000 mg/kg body weight based on test material.

Executive summary:

The acute dermal toxicity of Ammonium (xylenes and 4-ethylbenzene) sulfonates was assessed following official method OECD 402, Acute dermal Toxicity. No mortalities occurred in the study, 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. 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.