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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: scientifically acceptable study similar to guideline (limit test; non GLP, age of test animals not recorded)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report Date:
1974

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
test substance evaluated at unique 10000 mg/kg dose level
Deviations:
yes
Remarks:
age of test animals not recorded
Principles of method if other than guideline:
BASF-Test
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): chromgelb 62 F (chemical name: lead chromate, -sulfate)
- Physical state: crystal mixture
- Analytical purity: 85% PbCrO4
- Composition of test material, percentage of components: 85% PbCrO4 and 3%, also containing PbSO4, SbF3, Sb2O3 and SiO2 at unspecified percentages

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: SPF breed from WIGA, Sulzfeld
- Age at study initiation: no data
- Weight at study initiation: 205 g for males, 155 for females
- Fasting period before study: no data
- Diet: Altromin-R, Altrogge, Lage/L; ad libitum
- Water: ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
VEHICLE (aquous suspension with 0.5% CMC)
Dose (mg/kg bw) /10000
Concentrationof test substance in vehicle (%) /35
Applied volume (ml/kg) /28.57
Doses:
10000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Daily recording of signs and symptoms from the day of administration till the end of the observation period. Daily check (twice) for moribund and dead animals (once during the weekend).
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, pathology.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Remarks on result:
other: no mortality at this unique dose level
Mortality:
no mortality observed
Clinical signs:
only feces coloration and urin (yellow) up to day 7 after treatment, nothing abnormal afterwards
Body weight:
No adverse effects were reported (see Table 1)
Gross pathology:
nothing abnormal detected

Any other information on results incl. tables

Table 1: Body weight

Mean body weight at)

day after application

0

4

7

14

Males

205

227

246

264

Females

155

170

180

180

Applicant's summary and conclusion