Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Tests commenced on 19 September 1985 and completed on 29 October 1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study was conducted to internationally recognised guidelines but not to GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other:
Deviations:
yes
Remarks:
See notes in section " Principles of method if other than guideline"
Principles of method if other than guideline:
The study design differs from current OECD Test Guideline methods for acute oral toxicity (400, 423, 425), however, meets all data needs for hazard classification and labelling in the EU. Review of the study report revealed minor deviations from current scientific and technical standards.
The following minor deviations from current scientific and technical standards were noted:
- Test substance purity was not reported,
- Age of test animals was not reported.
These deviations are not considered to have influenced the outcome or the integrity of the study.
GLP compliance:
no
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
A test material in a container labelled Cuprous Thiocyanate CuSCN, Batch No. 8571 (gross weight 554g) was received on 07 August 1985.

Storage conditions: The test material was stored in the dark under ambient conditions.
Purity: Not provided.
Stability: Not provided.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River (U.K.) Limited
- Age at study initiation: No information was given on the age of the animals.
- Weight at study initiation: At the start of the study the males weighed 205 to 221 g and the females weighed 148 to 160 g.
- Fasting period before study: Deprived of food for 16-18h before dosing.
- Housing: Rats were housed in suspended plastic cages with mesh floors with a maximum of 5 animals per cage.
- Diet (e.g. ad libitum): Special Diet Services Expanded Rat and Mouse Maintenance Diet No. 1, allowed ad libitum.
- Water (e.g. ad libitum): Available ad libitum.
- Acclimation period: 9 days before test commencement

ENVIRONMENTAL CONDITIONS
- Temperature: Mean environmental temperature was 20°C (extremes of 19°C-22°C)
- Humidity: Mean relative humidity was 55% (extremes of 42 - 66%).
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light):

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
1%
Details on oral exposure:
Cuprous Thiocyanate was administered orally in a single dose by means of a gavage. The test material was prepared in 1% carboxymethyl cellulose before administration and each group was dosed at a constant dose volume of 20ml per kg body weight.
Doses:
Concentration: 5000 mg/kg bw
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of clinical observations: The rats were observed frequently on the day of dosing and for 14 days following dosing.
- Weighing: Animals were weighed immediately prior to dosing, 7 days after dosing and at the end of the 14 day observation period.
- Necropsy of survivors performed: Each animal was subjected to a gross post mortem examination.
Statistics:
Method of determination of LD50: Not applicable, limit dose study.

Results and discussion

Preliminary study:
Dose Range Finding Test
In the dose range finding test cuprous thiocyanate was administered to one male and one female at each of 7 dose levels. The dose levels investigated were 100, 500, 1000, 2000, 3000, 4000 and 5000 mg/kg bw.
The rats were observed frequently on the day of dosing and for 14 days following dosing. They were weighed immediately prior to dosing and at the end of the observation period. Each animal was subjected to a gross post mortem examination.
There were no deaths during the 14 day observation period.
There were no clinical signs recorded at any time during the 14 day observation period.
No abnormalities were noted after post mortem examination.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no deaths during the 14 day observation period.
Clinical signs:
No clinical signs were recorded at any time during the observation period.
Body weight:
All animals gained weight during the study.
Gross pathology:
At post mortem, gross examination revealed no abnormalities.
Other findings:
The LD50 was greater than 5000 mg/kg bw for both males and females.

Applicant's summary and conclusion

Conclusions:
The acute oral LD50 in the rat was greater than 5000 mg/kg bw for males and females.
In this study, copper thiocyanate does not meet the criteria for classification for acute oral toxicity according to Annex VI of Commission Directive 2001/59/EC.
Executive summary:

The execution of this type of short-term study is not individually inspected by the Quality Assurance Department. The processes involved are inspected at intervals according to a pre-determined schedule.

The report has been audited by IRI Quality Assurance Personnel according to the appropriate Standard Operating Procedures and is considered to describe the methods and procedure used in the study. The reported results accurately reflect the original data of the study.

The acute oral LD50 in the rat was greater than 5000 mg/kg bw for males and females.

In this study, copper thiocyanate does not meet the criteria for classification for acute oral toxicity according to Annex VI of Commission Directive 2001/59/EC.