Pentalead tetraoxide sulphate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

August-December 2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well-documented and corresponded to the requirements of the recommended Annex V test guidelines.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

Lead monoxide

EC Number:

215-267-0

EC Name:

Lead monoxide

Cas Number:

1317-36-8

Molecular formula:

OPb

IUPAC Name:

lead monoxide

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

Lead Oxide
- Name of test material (as cited in study report): Litharge-Lead Oxide
- Molecular formula (if other than submission substance): PbO
- Physical state: fine, yellow powder
- Analytical purity: 99.8%
- Composition of test material, percentage of components: PbO:99.8%; metallic Pb: <0.01; Pb3O4:0.003; Cu: <0.0001; Fe: 0.0008
- Lot/batch No.: 210213
- Expiration date of the lot/batch: May 2005
- Storage condition of test material: At room temperature.

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Winkelmann GmbH
- Age at study initiation:
- Weight at study initiation: males:286-317 g: females: 192-199 g
- Fasting period before study:
- Housing: The rats were housed collectively at 3 animals per cage. Before animals arrived study room and cages were cleaned and disinfected. During study, room and cages were cleaned at regular intervals.
- Diet (e.g. ad libitum): Teklad Global 18% Rodent Diet offered ad libitum
- Water (e.g. ad libitum): Tap water as for human consumption was continuously available ad libitum via drinking water. Water subject to periodic bacteriological tests and to chemical analyses.
- Acclimation period: 23 days (females); 28 days (males)


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3
- Humidity (%): 30-70
- Air changes (per hr): Air was changed about 16 times per hour and filtered adequately
- Photoperiod (hrs dark / hrs light): Artificia light was set to give a cyle of 12 hours light and 12 hours dark with light on at 7:00 AM.


IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

peanut oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20% formulation of the test article
- Amount of vehicle (if gavage):10 ml/kg
- Justification for choice of vehicle:
- Lot/batch no. (if required): 072K0107 SIGMA
- Purity:


MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg


DOSAGE PREPARATION (if unusual):


CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Initially the dose of 2000 mag/kg was administered to 3 male rats. Since no mortality was observed within a few days, the test article was administered subsequently to 3 male rats at the same dose of 2000 mg/kg.

Doses:

2000 mg/kg

No. of animals per sex per dose:

3 females and 3 males

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:The animals were examined 1 hr, 2 hr, 6 hr and 24 h after treatment and thereafter once daily up to day 14 of the study. Body weights were recorded immediately before treatment and days 7 and 14 p.a. (termination).
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, necropsy

Results and discussion

Preliminary study:

Initially, the dose of 2000 mg/kg was administered to 3 female rats. Since no mortality was observed within a few days, the test article was administered subsequently to 3 male rats at the same dose of 2000 mg/kg.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No male or female animal treated orally at the dose of 2000 mg/kg died prematurely

Clinical signs:

other: No clinical observations were observed in male and female animals during the 14-day observation period following the treatment at the dose of 2000 mg/kg.

Gross pathology:

Gross pathological examinations on day 14 p.a. (terminal necropsy) did not reveal test article-related findings.

Other findings:

spontaneous death n=0
killed in extremis n=0
terminal sacrifice 14 days p.appl. n=6

Animal no. Specific Findings
1-5 no specific findings
6 uterus: hydrometra

Applicant's summary and conclusion

Interpretation of results:

other: LD50 > 2000 mg/kg may be classified as "non-toxic" under EU (CLP) criteria. However, a conclusion cannot be made on GHS criteria.

Conclusions:

LD 50 >2000 mg/kg When administered by the oral route the test article may therefore be classified as "non-toxic."

Executive summary:

The acute oral toxicity of "LITHARGE lead oxide was investigated according to ATC method in one step using 3 male and 3 female rats. Three female animals were given a single oral administration of the test article Litharge lead oxide at a dose of 2000 mg/kg. Clinical observations were carried out at regular intervals during the 14-day observation period. Body weights were determined immediately before treatment and on 7 days and 14 p.a. Gross pathological examinations were carried out immediately at termination on all animals.

The following results were obtained:

-No animals died during the course of the 14-day observation period following the dose of 2000 mg/kg.

-No abnormal clinical signs were observed

-There was no influence of the treatment on the body weight development in all male and female animals during the 14-day observation period.

-Gross pathological examinations on day 14 p.a. did not reveal test article-related findings.

According to the EEC Directive 2001/59, 6 August 2001 and the Gefahrstoffverordnung (GefStoffV) of 15 November 1999 (BGB1. I, p.2233), the test article LITHARGE lead oxide can be classified as "non-toxic", since the oral LD50 value after 24 h and 14 days is expected to be higher than 2000 mg/kg in male and female Wistar rats.