Dicopper chloride trihydroxide

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:

1998

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Dicopper chloride trihydroxide

EC Number:

215-572-9

EC Name:

Dicopper chloride trihydroxide

Cas Number:

1332-65-6

Molecular formula:

ClCu2H3O3

IUPAC Name:

dicopper chloride trihydroxide

Details on test material:

- Name of test material (as cited in study report): Copper oxychloride
- Composition of test material, percentage of components: 57.3% w/w copper
- Lot/batch No.: 19872

Test animals

Species:

mouse

Strain:

other: Hsd:ICR(CD-1)

Sex:

male/female

Details on test animals or test system and environmental conditions:

The mice were acclimatised, housed in groups of up to five by sex and fasted overnight prior to dosing. Food was returned immediately after dosing.
Initial body weights were 26 to 33 g (males) and 23 to 28 g (females).

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Alembicol D (fractionated coconut oil)

Details on oral exposure:

VEHICLE
- Amount of vehicle (if gavage): 10ml/kg bw.

Doses:

Dose levels (based on a range-finding study) were 200, 400 and 800 mg/kg bw.

No. of animals per sex per dose:

Groups of five males and five females.

Control animals:

no

Details on study design:

Animals were observed frequently on the day of dosing and then daily for the 14 day post-dosing period. Animals were weighed prior to administration and after 7 days (on Day 8) and after 14 days (on Day 15) or at death. Decedents and animals surviving to 14 days were subject to gross necropsy.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

299 mg/kg bw

Based on:

test mat.

95% CL:

215 - 414

Mortality:

There was one male and one female mortality at 200 mg/kg bw. At 400 mg/kg bw all males and three females died, and at 800 mg/kg bw all males and four females died. The deaths occurred between Day 1 and Day 7. Refer to Table 1.

Clinical signs:

other: There was a variety of clinical signs recorded including reduced activity, salivation, partly-closed eyes, matted fur, staining of skin/fur in the urogenital region, liquid faeces, hunched posture, pallor, lethargy and unconsciousness. Males treated at 4

Gross pathology:

No gross findings were recorded in surviving animals. The most notable necropsy finding in animals that died during the study was green coloured material in the digestive tract. Staining of the skin/fur particularly the urogenital areas was also recorded in most animals.

Other findings:

None.

Any other information on results incl. tables

Table 1. Summary of Mortalities

Dose (mg/kg bw)	Males		Females
	Mortality	Time of death	Mortality	Time of death
200	1/5	Day 3	1/5	Day 2
400	5/5	Day 3; Day 4; Day 5 (2); Day 7	3/5	Day 2; Day 3 (2)
800	5/5	Day 1; Day 2 (3); Day 3	4/5	Day 1; Day 2; Day 4 (2)
Figures in parenthesis are the number which died on the day specified if more than one.

Applicant's summary and conclusion

Interpretation of results:

toxic

Remarks:

Migrated information Cat. 3 Criteria used for interpretation of results: EU

Conclusions:

The acute oral LD50 (calculated by probit analysis) of dicopper chloride trihydroxide to the mouse was 299 mg/kg bw for the sexes combined (with 95% confidence limits of 215 to 414 mg/kg bw). This study has been disregarded for classification and labelling purposes as the mouse is not a preferred species under REACH.

Executive summary:

A GLP-compliant acute oral toxicity study was conducted in accordance with the requirements of EU Guideline B.1 and OECD 401 without significant deviation. Dicopper chloride trihydroxide was administered as a suspension in Alembicol D.  Groups of five male and five female Hsd:ICR(CD-1) mice weighing 26 to 33 g (males) and 23 to 28 g (females) were used.  The mice were acclimatised, housed in groups of up to five by sex and fasted overnight prior to dosing. Food was returned immediately after dosing.  Dose levels (based on a range-finding study) of 200, 400 and 800 mg/kg bw were administered by single oral administration by metal cannula at 10 mL/kg on Day 1.  Animals were observed frequently on the day of dosing and then daily for the 14‑day post-dosing period.  Animals were weighed prior to administration and after 7 days (on Day 8) and after 14 days (on Day 15) or at death.  Decedents and animals surviving to 14 days were subject to gross necropsy.

There was one male and one female mortality at 200 mg/kg bw.  At 400 mg/kg bw all males and three females died, and at 800 mg/kg bw all males and four females died.  The deaths occurred between Day 1 and Day 7.  There was a variety of clinical signs recorded including reduced activity, salivation, partly-closed eyes, matted fur, staining of skin/fur in the urogenital region, liquid faeces, hunched posture, pallor, lethargy and unconsciousness.  Males treated at 400 and 800 mg/kg bw, and females treated at 800 mg/kg bw, produced faeces coloured blue, thought to be unabsorbed test substance.  Some of the symptoms became apparent on the day of treatment and others on Day 2 or later.  Surviving animals recovered within the first week after treatment.  All surviving animals showed expected weight gain during the study.  No gross findings were recorded in surviving animals at necropsy.  The most notable necropsy finding in animals that died during the study was green coloured material in the digestive tract.  Staining of the skin/fur particularly the urogenital areas was also recorded in most animals. The acute oral LD50 (calculated by probit analysis) of dicopper chloride trihydroxide to the mouse was 299 mg/kg bw for the sexes combined (with 95% confidence limites of 215 to 414 mg/kg bw).

This study has been disregarded for classification and labelling purposes as the mouse is not a preferred species under REACH.