Registration Dossier

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:
guideline study with acceptable restrictions
Remarks:
used in EU risk assessment report for Zinc metal

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Zinc
EC Number:
231-175-3
EC Name:
Zinc
Cas Number:
7440-66-6
Molecular formula:
Zn
IUPAC Name:
zinc
Details on test material:
- Name of test material (as cited in study report): Zincstaub, superfein 620
- Other: Zinc powder particle diameter was 5 micrometer

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
no further details provided

Administration / exposure

Route of administration:
oral: feed
Vehicle:
maize oil
Details on oral exposure:
In this study very fine zinc powder, labelled as “Zincstaub, superfein 620”, was given as a suspension in maize oil
Doses:
one dose of 2000 mg zinc/kg bw
No. of animals per sex per dose:
no data
Control animals:
not specified
Details on study design:
no further information
Statistics:
no information

Results and discussion

Preliminary study:
no information
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
no mortality observed
Clinical signs:
piloerection in all females, diarrhoea in one female
Body weight:
no adverse effects reported
Gross pathology:
no adverse effects reported
Other findings:
none

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
LD50 >2000 mg/kg bw
Executive summary:

A limit study with Wistar rats was carried out according to OECD guideline no. 401 to assess the oral LD50. Apart from piloerection in all females and diarrhoea in one female, no mortality or clinical signs were observed after dosing of 2000 mg zinc/kg bw during the 14 day observation period. In this study very fine zinc powder, labelled as “Zincstaub, superfein 620”, was given as a suspension in maize oil. The particle size was not given in this study, but according to the accompanying letter from the industry the particle diameter was 5 μm. An LD50-value of > 2000 mg/kg bw was reported