Benzenesulfonic acid, C10-16-alkyl derivs., calcium salts

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted according to OECD Guidelines and to GLP, but not fully reported.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

analog of 70024-69-0

IUPAC Name:

analog of 70024-69-0

Constituent 2

Reference substance name:

analog of 274-263-7

IUPAC Name:

analog of 274-263-7

Constituent 3

Reference substance name:

Analogue of Benzenesulfonic acid, mono-C16-24-alkyl derivs., calcium salts

IUPAC Name:

Analogue of Benzenesulfonic acid, mono-C16-24-alkyl derivs., calcium salts

Details on test material:

Test material dosed as received, purity not provided.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

None provided in study report.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 5000 mg/kg bw

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

yes

Details on study design:

Animals were observed for 14 days following administration of the test substance.
Bodyweights were recorded on the day of dosing and at 2, 7 and 14 days after dosing.

Necropsy of survivors performed: yes

Clinical signs were observed and bodyweights measured.

Statistics:

No mortality occurred. Use of statistics not indicated.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000

Remarks on result:

other: 95% CL not indicated. LD50 is greater than 5000 mg/kg bw.

Mortality:

Mortality did not occur in treated animals.

Clinical signs:

other: Diarrhoea and reduced food intake were observed in one treated female on day one of dosing.

Gross pathology:

No treatment related effects were observed on necropsy.

Any other information on results incl. tables

Table 2: Number of animals dead [and with evident toxicity] [and time range within which mortality occurred]

 

Dose (mg/kg bw)	Mortality (# dead/total)			Time range of deaths (hours)	Number with evident toxicity (#/total)
	Male	Female	Combined		Male	Female	Combined
Control	0/5	0/5	0/10		0/5	0/5	0/10
5000	0/5	0/5	0/10		0/5	1/5	0/10

Applicant's summary and conclusion

Interpretation of results:

Toxicity Category IV

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

No mortality has occured at doses of 5000 mg/kg bw. The study has therefore been completed as a limit test and the LD50 is considered to be more than 5000mg/kg

Executive summary:

In an acute oral toxicity study, groups of Sprague-Dawley rats (5/sex) were given a single oral dose of sodium 4-icosylbenzenesulfonate at doses of  0 or 5000  mg/kg bw and observed for 14 days.

 

No mortality occurred in this limit test, therefore an LD50 has not been determined.

This acute oral study is classified as acceptable. It satisfies the guideline requirement for an acute oral study OECD 401 in the rat.