Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1996-10-02 to 1996-12-02
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
- Date of receipt: 1996-08-12
- Name of the test substance: Puramex Zn (zinc lactate)
- General appearance: fine white powder
- Storage conditions: ambient temperature

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga, Germany
- Age at study initiation: 5-6 weeks old upon arrival
- Weight at study initiation: not specified
- Fasting period before study: prior to dosing, the animals were fasted overnight
- Housing: five animals per cage (stainless steel cages, fitted with wire-screen floor and front)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 to 23 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 50-85
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg bw
Doses:
500 and 2000 mg/kg bw
No. of animals per sex per dose:
2000 mg/kg bw: 5 males; 5 females
500 mg/kg bw: 5 males, 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: All visible reactions to treatment were recorded including severity, onset and duration. Observations were made within 1 hour and within 4 hours after dosing, and subsequently at least once daily throughout an observation period of 14 days.
- Frequency of weighing: The body weight of each animal was recorded immediately before dosing on day 0 and of the surviving animals on day 3, 7 and 14 of the study.
- Termination of the study: At the end ot the observation period on day 14 of the study, all surviving animals were killed with carbon dioxide and examined for external changes. The abdomen and the thorax of each animal was opened and examined for
gross pathological changes. The animals found dead were also examined for gross pathological changes.
Statistics:
None

Results and discussion

Preliminary study:
A screening was carried out with two males treated with a dose level of 2000 mg kg body weight to check for mortality. Since both animals survived it was decided to continue the study with that dose level.
Effect levels
Sex:
male/female
Dose descriptor:
approximate LD50
Effect level:
> 500 - < 2 000 mg/kg bw
Mortality:
The first two males treated with the 2000 mg/kg bw dose level survived treatment, whereas the other three males and five females were found dead within 3 days after dosing. All five males and five females treated with the 500 mg/kg dose level survived.
Clinical signs:
Sluggishness, blepharospasm, piloerection, soiled fur and diarrhoea were generally observed during the first day after dosing.
Body weight:
All animals gained weight during the 14-day test period.
Gross pathology:
Macroscopic examination of the animals at the end of the observation period did not reveal treatment-related gross alterations.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
In conclusion, the oral LD50 of Puramex Zn is considered to be between 500 and 2000 mg/kg bw; most likely value 1190 mg/kg bw (linear interpolation).
Executive summary:

In an acute oral toxicity study in accordance with OECD 401 the oral LD50 is considered to be between 500 and 2000 mg/kg bw; most likely value 1190 mg/kg bw (linear interpolation).