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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
well performed study according to GLP and OECD 423

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report date:
2000

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Version / remarks:
(directive 96/54/EEC)
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
[1,3-dihydro-5,6-bis[[(2-hydroxy-1-naphthyl)methylene]amino]-2H-benzimidazol-2-onato(2-)-N5,N6,O5,O6]nickel
EC Number:
255-965-2
EC Name:
[1,3-dihydro-5,6-bis[[(2-hydroxy-1-naphthyl)methylene]amino]-2H-benzimidazol-2-onato(2-)-N5,N6,O5,O6]nickel
Cas Number:
42844-93-9
Molecular formula:
C29H18N4NiO3
IUPAC Name:
Nickel, [1,3-dihydro-5,6-bis[[[2-(hydroxy-kO)-1-naphthalenyl]methylene]amino-kN]-2H-benzimidazol-2-onato(2-)]-, (SP-4-2)-
Test material form:
solid: nanoform

Test animals

Species:
rat
Strain:
other: Hanlbm: WIST (SPF)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: RCC Ltd, Biotechnology & Breeding Division, Füllinsdorf, Switzerland
- Age at study initiation: 9 1/2 weeks
- Weight at study initiation: 213.1 - 218.3 g (males); 163.3 - 171.7 g (females)
- Fasting period before study: 17 h
- Housing: Macrolon cages (type 4) in groups of three
- Diet: peletted standard Kliba 3433 rat maintenance diet (batch no. 04/00, Provimi Kliba AG, Kaiseraugst, Switzerland); ad libitum
- Water: community tap water; ad libitum
- Acclimation period: 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+-3
- Humidity (%): 36 - 57 %
- Photoperiod (hrs dark / hrs light): 12/12
- Air changes (per hr): 10 - 15

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
bi-distilled
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 0.2 g/mL (w/v); mixture was prepared shortly before each dosing
- Application volume: 10 mL/kg bodyweight
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3 males and 3 females per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: 1, 2, 3 and 5 hours after administration on day 1; twice daily during days 2 - 15
- Frequency of weighing: on test days 1, 8 and 15
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no animals died within the 14 day observation period
Mortality:
no deaths occurred during the study
Clinical signs:
other: moderate to marked orange coloration of faeces was observed for the females from day 2 to 4.
Gross pathology:
animals killed at the end of the observation period showed no macroscopically visible changes

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Single application of the limit dose of 2000 mg test substance per kg bodyweight did not cause lethality in male and female Wistar rats during the 14 day observation period, resulting in a LD50 > 2000 mg/kg bw.
Executive summary:

Male and female rats were treated orally to test acute oral toxicity according to the acute class method (OECD TG 423, limit test). The test substance was administered by gavage at the limit dose of 2000 mg/kg bw to two groups of 3 animals each. Orange discoloured faeces were observed in the group of female animals from day 2 to 4. The body weight development of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were observed at necropsy.

No animal died within the observation period, resulting in a LD50 > 2000 mg/kg bw.