Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No GLP, relatively poor documentation

Data source

Reference
Reference Type:
publication
Title:
Single oral toxicity of various organic compounds
Author:
Kinkead E.D., Wolfe R.E
Year:
1992
Bibliographic source:
Journal of the American College of Toxicology; 1992; 11:713

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
no details

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
no details
Doses:
2500, 5000, 6300, 7940, 10000
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no

Results and discussion

Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Effect level:
ca. 5 610 mg/kg bw
Based on:
test mat.
Sex:
male
Dose descriptor:
LD50
Effect level:
ca. 4 665 mg/kg bw
Based on:
test mat.

Any other information on results incl. tables

Five male and five female Sprague-Dawley rats were used per dose level. Water soluble compounds were administered in distilled water. Compounds that would not dissolve in water were administered as suspensions in corn oil. All rats were fasted prior to dosing and the gavage volume was maintained: at 0.01 mL/g body weight. All survivors were maintained for a 14-day observation period.

Geometrically spaced doses were administered to determine the LD50. Calculations were by moving average interpolation method of Weil, Biometrics 1952(8) 249-263.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
For lead acetate LD50 values of 4665 (3153 -6900) and 5610 mg/kg bw have been observed for male and female rats, respectively. It is reasonable to assume that the toxicity of lead salts is triggered by the lead cation and not the corresponding anion. Therefore, it is considered justified to use data from lead acetate also for other soluble lead salts like lead dinitrate, and lead dibasic. As the molar mass of lead acetate, lead dinitrate. lead dibasic are almost identical the LD50 value for lead acetate is also applicable for other lead salts.
Executive summary:

Five male and five female Sprague-Dawley rats were used per dose level. Lead acetate was administered in distilled water. All rats were fasted prior to dosing and the gavage volume was maintained: at 0.01 mL/g body weight. All survivors were maintained for a 14 -day observation period.

Geometrically spaced doses were administered to determine the LD50. Calculations were by moving average interpolation method of Weil, Biometrics 1952(8) 249-263.

For lead acetate LD50 values of 4665 (3153 -6900) and 5610 mg/kg bw have been observed for male and female rats, respectively.

It is reasonable to assume that the toxicity of lead salts is triggered by the lead cation and not the corresponding anion. Therefore, it is considered justified to use data from lead acetate also for other soluble lead salts.