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Diss Factsheets

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From January 01, 1984 to February 14, 1984
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:
1984

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Reference substance name:
Benzenesulfonic acid, C10-13-alkyl derivs., sodium salts
EC Number:
270-115-0
Cas Number:
68411-30-3
IUPAC Name:
Benzenesulfonic acid, C10-13-alkyl derivs., sodium salts
Test material form:
solid: particulate/powder

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
Source: F. Winkelmann
Weight at study initiation: 123 g female, 146 g male
Housing: 1-5 animals in Makrolon cages
Diet (e.g. ad libitum): R10 Alleidiaet fuer Ratten, ad libitum
Water (e.g. ad libitum): tap water, ad libitum
Acclimation period: 4-8 d
Temperature (°C): 20 +/- 1
Humidity (%): 60 +/- 5
Air changes (per hr): 15/hr
Photoperiod (hrs dark / hrs light): 12 hrs light/12 hrs dark

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
Concentration in vehicle: 12.5-19.9% in water
Maximum dose volume applied: 10 mL/kg
Doses:
0, 1250, 14515, 1580 and 1990 mg/kg bw (equivalent to 0, 1075, 1220, 1360 and 1710 mg/kg bw - corrected for 86% purity)
No. of animals per sex per dose:
5
Control animals:
yes
Details on study design:
Body weight and other signs were measured on Days 7 and 14. Animals were observed for 14 d after dosing. Necropsies were performed at the end of the study.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 080 mg/kg bw
Based on:
act. ingr.
Mortality:
Almost all animals died at doses of 1220 mg/kg bw and above.
Clinical signs:
Symptoms beginning about 30 min post application included diarrhea, squatting attitude, breathing difficulties, nose bleeding, ataxia, and lethargy. These symptoms had disappeared in surviving animals by 120 h.
Body weight:
No effects on body weight were seen.
Gross pathology:
In the animals that died before the end of the study, red mucous was seen in the stomach and intestine. In the surviving animals, hyperemia of the stomach was noted, along with abnormalities of the stomach, liver, spleen, kidneys, and the peritoneum.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
Under the study conditions, the acute oral LD50 of the substance was determined to be 1080 mg/kg bw in rats.
Executive summary:

A study was conducted to determine the acute oral toxicity of the test substance according to OECD Guideline 401. The test substance was administered to male and female rats by oral gavage at doses of 0, 1075, 1220, 1360 or 1710 mg/kg bw (active ingredient). Animals were observed for 14 d after dosing. Body weights were measured on Days 7 and 14. Necropsies were performed at the end of the study. Almost all animals died at doses of 1220 mg/kg bw and above. Symptoms beginning about 30 min post administration included diarrhea, squatting, breathing difficulties, nose bleeding, ataxia, and lethargy. These symptoms disappeared in surviving animals by 120 h. No effects on body weight were seen. In the animals that died before the end of the study, red mucous was seen in the stomach and intestine. In the surviving animals, hyperemia of the stomach was noted, along with abnormalities of the stomach, liver, spleen, kidneys, and the peritoneum. Under the study conditions, the acute oral LD50 of the substance was determined to be 1080 mg/kg bw in rats (Murmann, 1984).