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Diss Factsheets

Toxicological information

Acute Toxicity: dermal

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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

Constituent 1
Chemical structure
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.