Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1984
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Laboratory study from experienced laboratory.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
other: not specified
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Benzenesulfonic acid, C10-13-alkyl derivatives (85536-14-7)

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
Male and female WISW rats averaging 143 g (male) and 117 g (female) in weight. Animals were marked on the fur and held in groups. They were acclimated for 4 to 8 days prior to testing. Standard diet and water was provided ad libitum. Room temperature was held at 20 ± 1°C, humidity at 60 ± 5%, with a 12/12 hour light/dark cycle.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
The test duration was 14 days.
Doses:
Doses were 1250, 1415, 1580 and 1990 mg/kg.
No. of animals per sex per dose:
10 - Five of each sex per dose level were tested.
Control animals:
not specified
Details on study design:
Animals were weighed immediately before treatment and at 1, 7 and 14 days. At 6 hours and then daily thereafter all animals were observed for symptoms of toxicity. Autopsies were conducted at test termination.
Statistics:
LD50 by Litchfield and Wilcoxon.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 1 470 mg/kg bw
95% CL:
> 1 361 - < 1 588
Mortality:
9 animals in the 1580 and 1990 mg/kg dose died. In the other doses, the number of animals that died were 0 and 3 of 10 for the 1250 and 1415 mg/kg doses, respectively.
Clinical signs:
Within approximately 30 minutes of application, symptoms observed included dry skin, diarrhea, squatting attitude, small dark red eyes, ataxia, hypothermia, diuresis, occasional trembling, tumbling, and prone position.
Gross pathology:
Post mortem sections showed strong hyperemias and swelling, as well as partial damage to the stomach and intestinal mucosae. Also, effects to the stomach, liver, and peritoneum were seen. The tissue sections showed swelling of the gastric mucosa in 3 animals, as well as the growing together of organs of the abdominal cavity with the diaphragm in 2 animals.

Applicant's summary and conclusion

Conclusions:
The test material is slightly toxic to rats following acute oral exposure.
Executive summary:

Ten rats per dose (five of each sex) were given oral gavage doses of the test material ranging from 1250 to 1990 mg/kg. The resulting LD50 value was 1470 mg/kg.