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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study (OECD)
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
yes
Test type:
other:
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Nickel sulfide
EC Number:
234-349-7
EC Name:
Nickel sulfide
IUPAC Name:
Nickel sulfide
Details on test material:
- Name of test material (as cited in study report): Nickel sulfide
- Substance type: amorphous nickel sulfide, aqueos slurry
- Elemental composition: 52.4% Ni, 31.85% S

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc., Wilmington, MA
- Age at study initiation: adult
- Weight at study initiation: ~ 292 g (males); ~199 (females)
- Fasting period before study: night before study
- Housing: Animals were individually housed in wire mesh bottom cages in environment controlled rooms.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 5000 mg/kg



CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:
used a range finder
Doses:
Range Finding Study: 100, 266, 707, 1880, 5000 mg/kg
Mortality Study: 5000 mg/kg
No. of animals per sex per dose:
5 male; 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: "frequently" on the day of exposure; twice daily thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
Not reported.

Results and discussion

Preliminary study:
No mortality in rat groups (n=10) exposed to 5000 mg/kg at 15 days post-exposure.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
None.
Clinical signs:
other: Diarrhea (1/5 males; 0/5 females)
Gross pathology:
No noteworthy findings.
Other findings:
None.

Applicant's summary and conclusion

Conclusions:
Based on the data obtained from this study, the acute oral LD50 is considered to be greater than 5000 mg/kg bodyweight.