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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
other information
Study period:
2008
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report date:
2008

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
GLP compliance:
yes (incl. QA statement)
Remarks:
see report
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water

Results and discussion

Preliminary study:
No mortality at 2000 mg/kg b. w. either for males or for females.
Mortality:
No mortality
Clinical signs:
No signs of systemic toxicity
Body weight:
All animals showed expected gains in bodyweight
Gross pathology:
No abnormalities were noted at necropsy

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
The acute oral median lethal dose (LD50) of the organic part of PACTT, 2 Na in the female Sprague-Dawley CD strain rat was estimated to be greater than 2000 mg/kg body weight. As the mineral part of PACTT, 2 Na, Sodium Bromide is not either classified for acute oral toxicity, the multi constituent substance is not classified for acute oral toxicity according to GHS criteria.