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Toxicological information

Acute Toxicity: oral

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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: 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:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
not specified
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 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 occured. 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:
Diarrhoea and reduced food intake were observed in one treated female on day one of dosing.
Body weight:
No significant change in bodyweight 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

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 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 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.