Reaction product of soluble nickel salt, cobalt salt, manganese salt with alkalines

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

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

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Hypothesis for read-across: Cobalt dihydroxide and nickel dihydroxide are the main components of the target UVCB-substance, and considered the major drivers for adverse effects based on its properties and relative quantity in the substance. For read-across purpose, data from the constituents (cobalt dihydroxide and nickel dihydroxide) of the target UVCB-substance is used in the REACH registration. A well described guideline study for cobalt dihydroxide.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1952

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Cobalt dihydroxide

EC Number:

244-166-4

EC Name:

Cobalt dihydroxide

Cas Number:

21041-93-0

Molecular formula:

CoH2O2

IUPAC Name:

cobalt(2+) dihydroxide

Details on test material:

No further details given.

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: not stated
- Age at study initiation: "young"
- Weight at study initiation:200-300g
- Fasting period before study: yes, no period given
- Housing: not stated
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: not stated

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

propylene glycol

Doses:

250, 500, 1000, 2000, 4000, 8000mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: no

Statistics:

nmot reported

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD0

Effect level:

500 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 060 mg/kg bw

Based on:

test mat.

95% CL:

> 680 - 1 660

Effect levels 3

Sex:

male/female

Dose descriptor:

LD100

Effect level:

4 000 mg/kg bw

Based on:

test mat.

Mortality:

yes

Clinical signs:

other: diarrhea, ruffled fur, debilitation

Gross pathology:

not conducted

Any other information on results incl. tables

Cobalt hydrate powder

fasted male and female albino rats

weights 200 -300 grams

vehicle: polypropylene glycol

Dose level	No. animals	Number of days and deaths														total
		1	2	3	4	5	6	7	8	9	10	11	12	13	14	survivals	Deaths
250	5															5	0
500	5															5	0
1000	5					1				1	1					2	3
2000	5					1	1			1	1					1	4
4000	5				4						1					0	5
8000	5		2		2	1										0	5

 

Justification for read-across: Cobalt dihydroxide and nickel dihydroxide are the main components of the target UVCB-substance, and considered the major drivers for adverse effects based on its properties and relative quantity in the substance. For read-across purpose, data from the constituents (cobalt dihydroxide and nickel dihydroxide) of the target UVCB-substance is used. According to section 1.5, annex XI of regulation (EC) 1907/2006, such studies do not need to be conducted, since adequate data from structurally analogous substances are available. Therefore read-across from these compounds is justified.

Applicant's summary and conclusion

Interpretation of results:

Toxicity Category IV

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The following LD50 value was determined for cobalt dihydroxide:
LD50 (combined male and female rats): 1060 mg/kg bw
According to the criteria specified by Directive 67/548/EEC and subsequent regulations, the test item is classified as harmful.
According to the EC Regulation No. 1272/2008 and subsequent regulations, the test item is classified as Category 4.