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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

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 levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Sex:
male/female
Dose descriptor:
other: LOAEL local
Effect level:
19 other: mg/cm2
Mortality:
No mortality occured during the study.
Clinical signs:
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 and day 4, these cutaneous reactions were associated with dryness and on day 5, red spots and outbreak of a scab were noted on the treated area. No cutaneous reactions were noted from day 6.
Body weight:
The body weight evolution of the animals remained normal throughout the study.
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.

Applicant's summary and conclusion