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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
Chemical structure
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:
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.

Applicant's summary and conclusion