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Toxicological information

Acute Toxicity: oral

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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted according to Guidelines and to GLP, but not fully reported.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: FHSA 16CFR1500.3
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
test material purity quoted as 46% active.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
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 7 and 14 days after dosing.

Necropsy of survivors performed: yes

Clinical signs were observed daily and bodyweights measured. Histopathological examination was performed on grossly abnormal tissues.
Statistics:
Use of statistics not indicated.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: 95% CL not indicated. LD50 is greater than 2000 mg/kg bw.
Mortality:
One treated female died on day 5.
Clinical signs:
Ruffled fur in treated animals was observed 3 hours post dosing. Urine staining was observed 24-48 hours following dosing, but was normal after 72 hours.
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

2000

 0/5

1/5

0/10 

 120

 5/5

5/5 

10/10 

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Only one death in female animals occurred at 2000 mg/kg bw, therefore, and LD50 was not determined.
Executive summary:

In an acute oral toxicity study, groups of Sprague-Dawley rats (5/sex) were given a single oral dose of petroleum derived barium salts at 2000 mg/kg bw and observed for 14 days.

One mortality occurred in this limit test, therefore the LD50 > 2000 mg/kg.

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