Nickel(2+) propionate

Acute Toxicity: oral

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:

guideline study

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)

Version / remarks:

2006

GLP compliance:

yes

Test type:

up-and-down procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

nickel(2+);diacetate;tetrahydrate

EC Number:

611-946-4

Cas Number:

6018-89-9

Molecular formula:

C4H14NiO8

IUPAC Name:

nickel(2+);diacetate;tetrahydrate

Specific details on test material used for the study:

Ni content 24 %

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ace Animals, Inc. (Boyertown, PA)
- Females nulliparous and non-pregnant: yes
- Housing: individually in suspended stainless steel cages with mesh floors
- Diet and Water: Purina Rodent Chow #5012 and filtered tap water ad ibitum.
- Acclimation period: 7-30 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-24
- Humidity (%): 15-87
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Doses:

175, 550 and 2000 mg/kg bw

No. of animals per sex per dose:

total number of animals: 8

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, behaviour

Statistics:

The Acute Oral Toxicity (Guideline 425) Statistical Program (Westat, version 1.0, May 2001) was used for all data analyses including: dose progression selections, stopping criteria determinations and/or LD50 and confidence limit calculations. To more accurately determine the LD50, dose progressions were completed based on a sigma equal to 0.0 or 0.1.

Results and discussion

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

LD0

Effect level:

175 mg/kg bw

Based on:

test mat.

Effect levels 2

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

550 mg/kg bw

Based on:

test mat.

95% CL:

>= 192 - <= 1 680

Mortality:

Mortality (number animals dead/surviving) during the 14 day observation period was 0/2, 2/4, and 2/2 for the 175, 550, and 2000 mg/kg dose groups, respectively.

Clinical signs:

Non-specific effects, such as hypoactivity and piloerection, were observed starting at
the 550 mg/kg dose level.

Gross pathology:

Red intestines were noted at necropsy in the two highest dose groups.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The LD50 value of the test substance was determined to be 550 mg/kg bw.