Benzenesulfonic acid, mono-C11-13-branched alkyl derivs., sodium salts

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Well documented journal article.

Data source

Reference

Reference Type:

publication

Title:

Toxicologic Studies with Branched and Linear Alkyl Benzene Sulfonates in Rats

Author:

Oser, BL, and Morgareidge, K

Year:

1965

Bibliographic source:

Toxicology and Applied Pharmacology 7, 819-25

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Hagan, EC (1959). Acute toxicity. In: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. pp. 17-25. Assoc. of Food and Drug Officials of the US, Bureau of Food and Drugs, Texas State Dept. of Health, Austin, Texas.

GLP compliance:

no

Remarks:

Study performed in 1965 prior to implementation of GLP.

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

BABS Na salt

IUPAC Name:

BABS Na salt

Constituent 2

Reference substance name:

LAS

IUPAC Name:

LAS

Details on test material:

This study compared the toxicity of branched alkyl benzene sulfonates (BABS Na salt) to that of linear alkyl benzene sulfonates (LAS).

BABS Na salt:
- Physical state: off-white powder
- Impurities (identity and concentrations): petroleum ether-soluble 0.9%, sodium sulfate 10.5%, water 2.2%
- Composition of test material, percentage of components: 87.1% active ABS, average molecular weight 347, average chain length 12

LAS:
- Physical state: yellow viscous liquid
- Impurities (identity and concentrations): free alkali 0.05%, sodium sulfate 8.8%, water 50.9%
- Composition of test material, percentage of components: 39.5% active ABS, average molecular weight 346, average chain length 12

Test animals

Species:

rat

Strain:

other: FDRL

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: young adult
- Fasting period before study: overnight

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 10% dispersion in water, LAS was also given in a 40% dispersion
- Purity: distilled water

Doses:

graded doses
LAS: 0.6, 1.58 g/kg

No. of animals per sex per dose:

3 rats of each sex per dose

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations for behaviour, appearance and survival were made daily; weighings were performed on days 0, 7, and 14
- Necropsy of survivors performed: yes

Statistics:

LD50 calculated by the method of Miller, LC, and Tainter, ML. (1994). Estimation of the ED50 and its error by means of logarithmic-probit graph paper. Proc. Soc. Exptl. Biol. Med. 57, 261-264.

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

0.52 other: g/kg

Based on:

act. ingr.

95% CL:

0.424 - 0.614

Remarks on result:

other: BABS Na salt

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

0.65 other: g/kg

Based on:

act. ingr.

95% CL:

0.587 - 0.713

Remarks on result:

other: LAS

Mortality:

No effects.

Clinical signs:

other: At the high LAS dose, a high incidence of diarrhea was noted. Animals that died during the study showed weakness and reduced activity prior to death.

Gross pathology:

No effects.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Remarks:

Migrated information

Conclusions:

The acute oral LD50 for BABS Na salt in rats is 520 mg/kg bw. This places BABS Na salt in toxicity category 4.

Executive summary:

Groups of 3 male and 3 female rats were administered various doses of BABS Na salt or LAS. The animals were oberseved for 14 days for survival, behaviour, and appearance. In addition, body weights were taken on days 0, 7, and 14. The LD50 for BABS Na salt was 520 mg/kg, and the LD50 for LAS was 650 mg/kg. The LD50s for LAS and BABS Na salt were not statistically different. This demonstrates that LAS is a suitable analog for BABS Na salt regarding toxicity.