Trinickel dicitrate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

04 Sep - 12 Nov 2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Secrétariat général du GIPC, DGE-Simap, 12 rue Villiot, 75572 Paris cedex 12, France

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Nickel(2+) hydrogen citrate

EC Number:

242-533-3

EC Name:

Nickel(2+) hydrogen citrate

Cas Number:

18721-51-2

Molecular formula:

C6H8O7.Ni

IUPAC Name:

hydrogen nickel(2+) citrate

Details on test material:

- Name of test material (as cited in study report): Nickel Hydrogencitrat
- Physical state: green powder
- Analytical purity: > 99%
- Lot/batch No.: WRG 09012701037
- Expiration date of the lot/batch: 26 Jan 2011
- Storage condition of test material: room temperature, in darkness

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage JANVIER, 53940 Le Genest St Isle, France
- Age at study initiation: males: 7 weeks; females: 8 weeks
- Weight at study initiation: males: 225-247 g; females: 202-237 g
- Housing: During treatment, animals were caged individually. On day 2, two or three animals were put per cage.
- Diet (e.g. ad libitum): M20-rat/mouse maintenance
- Water (e.g. ad libitum): tap water from public distribution
- Acclimation period: at least five days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 15 Sep 2009 To: 29 Sep 2009

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: at least 10% of body surface area (25 cm2)
- Type of wrap if used: porous gauze dressing


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 mL/kg bw
- Concentration (if solution): 2000 mg/10 mL
- Constant volume or concentration used: no
- For solids, paste formed: no


VEHICLE
- Purity: distilled

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

other: control study

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observations; weighing was performed on day 0 just before substance administration and on days 2, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Effect levels 2

Sex:

male/female

Dose descriptor:

other: LOAEL local

Effect level:

19 other: mg/cm2

Mortality:

No mortality occured during the study.

Clinical signs:

other: No systemic clinical signs related to the administration of the test item were observed. Concerning the cutaneous reactions, a moderate erythema associated with red spots was noted on the treated area of treated females only (5/5) on day 1. Between day 2

Gross pathology:

The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.

Any other information on results incl. tables

The dose of 2000 mg/kg bw corresponds to 474 mg/animal. Sincethe treated area was 25 cm2, a local LOAEL of 19 mg/cm2 can be deduced.