Benzenesulfonic acid, C10-13-alkyl derivs., sodium salts

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Jan. 1, 1984-Feb. 14, 1984

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well-documented publication/study report which meets basic scientific principles.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Benzenesulfonic acid, C10-13-alkyl derivs., sodium salts

EC Number:

270-115-0

EC Name:

Benzenesulfonic acid, C10-13-alkyl derivs., sodium salts

Cas Number:

68411-30-3

Molecular formula:

Not applicable for UVCB

IUPAC Name:

sodium 4-undecylbenzenesulfonate

Test animals

Species:

rat

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: F. Winkelmann
- Weight at study initiation: 123 g female, 146 g male
- Fasting period before study:
- 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 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1 degree C
- 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:

VEHICLE
- Concentration in vehicle: 12.5-19.9% in water

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg

Doses:

LAS doses of 1075, 1220, 1360, 1710 or a control
Note that all doses are corrected for 86% activity. The original doses were 1250, 1415, 1580 and 1990 mg/kg.

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 days after dosing.
Necropsies were performed at the end of the study.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 080 mg/kg bw

Based on:

act. ingr.

Mortality:

Virtually all animals died in doses of 1220 mg/kg and above.

Clinical signs:

other: Symptoms beginning about 30 minutes past application included diarrhea, squatting attitude, breathing difficulties, nose bleeding, ataxia, and lethargy. These symptoms had disappeared in surviving animals by 120 hours.

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.

Any other information on results incl. tables

Mortality

Dose (mg/kg)	Sex	Mortality
1075	Male	0
	Female	4
1220	Male	5
	Female	3
1360	Male	4
	Female	5
1710	Male	5
	Female	5

Applicant's summary and conclusion

Interpretation of results:

Toxicity Category IV

Conclusions:

The acute oral LD50 is 1080 mg/kg. According to EU GHS guidelines, the test substance is a Category IV toxicant.

Executive summary:

This study examined the oral toxicity of the test substance in rats. Groups of 5 male and 5 female rats were exposed orally to 0, 1075, 1220, 1360, or 1710 mg/kg of test substance. The animals were then monitored for 14 days for mortality and clinical signs. All animals showed signs of toxicity. Mortality was seen at all dose levels, with 4 of 10 animals at the lowest dose level dying. All animals at the highest dose level died. The acute oral LD50, when adjusted for activity was 1080 mg/kg. According to EU GHS guidelines, the test substance is a Category IV toxicant.