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Diss Factsheets

Toxicological information

Acute Toxicity: dermal

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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

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 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 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.