Benzenesulfonic acid, C10-24-branched and linear alkyl derivs., magnesium salts, overbased

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Study period:

1984

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:

1984

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:

Sulfonic acids, petroleum, calcium salts, overbased

EC Number:

272-213-9

EC Name:

Sulfonic acids, petroleum, calcium salts, overbased

Cas Number:

68783-96-0

Constituent 2

Reference substance name:

petroleum derived calcium salt, overbased

IUPAC Name:

petroleum derived calcium salt, overbased

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

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 mg/kg bw

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:

No clinical signs of toxicity were observed.

Body weight:

No significant change in bodyweights occurred in treated animals.

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	0/5	0/10

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Mortality did not occur at doses of 5000 mg/kg bw, therefore, the LD50 > 5000 mg/kg.

Executive summary:

In an acute oral toxicity study, groups of Sprague-Dawley rats (5/sex) were given a single oral dose of petroleum derived calcium salts at 5000 mg/kg bw and observed for 14 days.

No mortality occurred in this limit test, therefore the LD50 > 5000 mg/kg.

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