Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
Between 28 February 1972 and 21 March 1972
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study not conducted to guidelines or GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1972
Report date:
1972

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Adult albino male Sprague-Dawley rats were fasted for 24 hours, then given a single dose and placed in screen bottom cages with free access to water and laboratory chow for a two week observation period.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Reference substance name:
Benzenesulfonic acid, mono-C16-24-alkyl derivs., calcium salts
EC Number:
274-263-7
EC Name:
Benzenesulfonic acid, mono-C16-24-alkyl derivs., calcium salts
Cas Number:
70024-69-0
IUPAC Name:
sodium 4-icosylbenzenesulfonate
Details on test material:
the test substance was a similar material to the registered substance (aryl alkyl sulphonate)

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 20000 mg/kg bw
Doses:
5000, 10000, 20000 mg/kg bw
No. of animals per sex per dose:
6 males
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
Statistics:
Use of statistics not indicated.

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 10 000 - < 20 000 mg/kg bw
Remarks on result:
other: 95% CL not indicated
Mortality:
5/6 males died on the third day following dosing in the 20000 mg/kg bw group.
Clinical signs:
No data.
Body weight:
No data.
Gross pathology:
No data.

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

5000

0/6

0/0

0/6

 

unknown

unknown

unknown

 10000 0/6   0/0  0/6    unknown  unknown  unknown
 20000  5/6  0/0  0/6  72  unknown  unknown  unknown

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: EU-GHS
Conclusions:
Mortality occurred at 20000 mg/kg bw. The LD50 is considered to be between 10000 and 20000 mg/kg bw but has not been determined precisely.
Executive summary:

In an acute oral toxicity study, groups of Sprague-Dawley rats (6 males) were given a single oral dose of C14-24 alkaryl calcium salt derivatives at 5,000, 10,000 or 20,000 mg/kg bw and observed for 14 days. Mortality occurred at 20,000 mg/kg bw, therefore the LD50 is considered to be between 10,000 and 20,000 mg/kg bw.