Dicopper sulphide

Acute Toxicity: oral

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:

other: Study conducted in compliance with Good laboratory Practice and internationally accepted guidelines.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Dicopper sulphide

EC Number:

244-842-9

EC Name:

Dicopper sulphide

Cas Number:

22205-45-4

Molecular formula:

Cu2S

IUPAC Name:

Copper(I) sulphide

Details on test material:

- Name of test material (as cited in study report): Dicopper sulphide.
- Analytical purity: >99%
- Lot/batch No.: CM25005
- Storage condition of test material: room temperature in the dark

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Oxon, UK.
- Age at study initiation: Eight to twelve weeks.
- Weight at study initiation: 149 - 177 grams.
- Fasting period before study: Overnight.
- Housing: The animals were housed in groups of up to four in suspended solid floor polypropylene cages furnished with woodflakes.
- Diet (e.g. ad libitum): ad libitum.
- Water (e.g. ad libitum): ad libitum.
- Acclimation period: At least five days.

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

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 30 mg/ml and 200 mg/ml
- Amount of vehicle (if gavage): 10 ml/kg
- Justification for choice of vehicle: Arachis oil BP was used because the test item did not dissolve/suspend in distilled water.

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: In the absence of data regarding the toxicity of the test item, 300 mg/kg was chosen as the starting dose.

Doses:

Following a sighting test usng one animal at dose levels of 300 mg/kg and 2000 mg/kg, a further group of four fasted females was given a single oral dose of test item at a dose level of 2000 mg/kg bodyweight.

No. of animals per sex per dose:

See Doses.

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: Clinical observations were made ½, 1, 2, and 4 hours after dosing and then daily for fourteen days. Morbidity and mortality checks were made twice daily. Individual bodyweights were recorded on Day 0 (the day of dosing) and on Days 7 and 14.
- Necropsy of survivors performed: yes.
- Other examinations performed: clinical signs, gross lesions, body weight.

Results and discussion

Preliminary study:

A sighting test at dose levels of 300 mg/kg and 2000 mg/kg resulted in no mortality and no clinical signs of systemic toxicity. All animals showed expected gains in bodyweight and no abnormalities were noted at necropsy.

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths.

Clinical signs:

other: There were no signs of systemic toxicity.

Gross pathology:

No abnormalities were noted at necropsy.

Other findings:

None.

Any other information on results incl. tables

Bodyweights recorded over the course of the study are shown in Tables 1 and 2.

Table 1: Individual Bodyweights and Bodyweight Changes -300mg/kg.

Dose Level mg/kg	Animal Number and Sex	Bodyweight (g) at Day			Bodyweight Gain (g) During Week
		0	7	14	1	2
300	1-0 Female	177	208	220	31	12

 

Table 2: Individual Bodyweights and Bodyweight Changes -2000mg/kg.

Dose Level mg/kg	Animal Number and Sex	Bodyweight (g) at Day			Bodyweight Gain (g) During Week
		0	7	14	1	2
2000	2-0 Female	154	171	185	17	14
	3-0 Female	149	160	217	11	57
	3-1 Female	148	161	195	13	34
	3-2 Female	160	173	222	13	49
	3-3 Female	154	169	215	15	46

 

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bodyweight (Globally Harmonised Classification System - Unclassified). The test item was also unclassified according to Appendix 4 of Method B1 bis Acute Toxicity (Oral) of Commission Regulation (EC) No. 440/2008.

Executive summary:

A GLP-compliant study was performed to assess the acute oral toxicity of dicopper sulphide in the Wistar strain rat. The method was designed to be compatible with OECD Guideline 420 and EU Method B.1 bis. Following a sighting test at dose levels of 300 mg/kg and 2000 mg/kg, a further group of four fasted females was given a single oral dose of test item, as a suspension in arachis oil BP, at a dose level of 2000 mg/kg bodyweight. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.

There were no deaths. There were no signs of systemic toxicity. All animals showed expected gains in bodyweight. No abnormalities were noted at necropsy. The acute oral median lethal dose (LD50) of the dicopper sulphide in the female Wistar strain rat was > 2000 mg/kg bodyweight (Globally Harmonised Classification System - Unclassified). The test item was also unclassified according to Appendix 4 of Method B1 bis Acute Toxicity (Oral) of Commission Regulation (EC) No. 440/2008.