(xylenes and 4-ethylbenzene)sulfonic acids

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

other: Read across from a member of the Hydrotropes category

Adequacy of study:

weight of evidence

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:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Principles of method if other than guideline:

20 adults (10 male, 10 female); single exposure for 24 hours; two dosage levels; full suite of observations and measures for 14 days.

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sodium (xylenes and 4-ethylbenzene) sulfonates

EC Number:

701-037-1

Molecular formula:

-

IUPAC Name:

Sodium (xylenes and 4-ethylbenzene) sulfonates

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS- Source: no data- Age at study initiation: "young"- Weight at study initiation: 2.49 to 3.01 kg- Fasting period before study: no data- Housing: individually housed in metal cages elevated above the 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 dataIN-LIFE DATES: From: July 18 To: August 1, 1979

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE- Area of exposure: trunk; clipped free of hair and epidermal abraded very two or three centimeters longitudinally over the area of exposure. The abrasions were sufficiently deep to penetrate the stratum corneum but not deep enough to disturb the derma.- % coverage: no data- Type of wrap if used: plastic binder secured with adhesive tapeREMOVAL OF TEST SUBSTANCE- Washing (if done): excess wiped with a paper towel- Time after start of exposure: 24 hoursTEST MATERIAL- Amount(s) applied (volume or weight with unit): no data- Concentration (if solution): undiluted- Constant volume or concentration used: yesVEHICLE- 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:

not specified

Details on study design:

- Duration of observation period following administration: 14 days- Frequency of observations and weighing: observations daily for 5 days/wk; weighing at 7 and 14 days after dosing - Necropsy of survivors performed: yes- Other examinations performed: clinical signs, body weight,organ weights, histopathology

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:

none

Clinical signs:

other: At 72-hour reading, 6 of 20 showed minimal erythema and/or edema of the skin at the treatment site. During the second week of the observation period, 10 of 20 showed minimal to slight fissuring, dryness and/or desquamation of the skin.A wry neck condition

Gross pathology:

19 of the 20 animals showed tissues to be not remarkable. A decrease of visceral fatty tissue and an accumulation of clear watery fluid within the peritoneal cavity were noted in the remaining animal.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 is > 2000 mg/kg bw based on test material.

Executive summary:

The acute dermal toxicity of Sodium (xylenes and 4-ethylbenzene) sulfonates was assessed following official method OECD 402, Acute dermal Toxicity. At 72-hour reading, 6 of 20 showed minimal erythema and/or edema of the skin at the treatment site. During the second week of the observation period, 10 of 20 showed minimal to slight fissuring, dryness and/or desquamation of the skin. 19 of the 20 animals showed tissues to be not remarkable. A decrease of visceral fatty tissue and an accumulation of clear watery fluid within the peritoneal cavity were noted in the remaining animal.