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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2001
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP study according to OECD Guideline 423 and EU Method B.1 tris Considering the lack of information on purity and particle size, a reliablility of 2 is assigned

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Lot/batch number: not provided
Specification: no information was provided on the specification of the sample used in this study
Purity: not provided
Stability: Test substance: not provided. Test preparations: Not assessed, however, test substance preparations were freshly prepared.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Source: charles river (UK) Ltd, Margate, Kent, UK
At the start of the study the males weighed 271 to 299 g and the females weighed 198 to 218g, and were approximately eight weeks of age.
3 animals per group

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
arachis oil
Details on oral exposure:
the test material was administered orally as a suspension inarachis oil BP.
Doses:
200 and 2000 mg/kg bw
concentration in vehicle: 20 and 200 mg/ml at 200 and 2000 mg/kg bw, respectively
Total volume applied: 10 ml/kg
No. of animals per sex per dose:
A group of three fasted females was treated with 2000 mg/kg bw.
Further groups of 3 male and 3 female fasted animals were treated at a dose level of 200 mg/kg bw.
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
300 - 500 mg/kg bw
Mortality:
Two animals treated with 2000 mg/kg bw were found dead five days after dosing.
One animal treated with 2000 mg/kg bw was killed in extremis eight days after dosing.
There were no deaths noted at a dose level of 200 mg/kg bw.
Clinical signs:
Signs of systemic toxicity noted in animals treated with 2000 mg/kg bw were hunched posture, lethargy, pilo-erection, diarrhoea, decreased respiration rate, laboured respiration, ataxia, pallor of the extremities, emaciation, tiptoe gait and faeces stained green. Hunched posture was noted during the day of dosing and one day after dosing in one mail treated with 200mg/kg bw. No other signs of systemic toxicity were noted in animals treated with 200 mg/kg bw.
Body weight:
the surviving animals showed expected gains in bodyweight over the study period
Gross pathology:
abnormalities noted at necropsy of the animals treated with 2000 mg/kg bw that died during the study were abnormally red lungs, dark liver, dark kidneys, copper-coloured material present in the stomach, haemorrhagic gastric mucosa, sloughing of the non-glandular epithelium of the stomach and haemorrhagic small and large intestines.

No abnormalities were noted at necropsy of animals treated with 200 mg/kg bw.
Other findings:
The LD50 of the test material was estimated to be in the range of 300-500 mg/kg bw

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material from the manufacturere corresponds to the composition of “ coated copper flakes” .
The acute oral LD50 of the test material in the rat was estimated to be in the range of 300 - 500 mg/kg bw. Coated copper flakes therefore meet the criteria for classification as harmful according to Annex VI of Commission Directive 2001/59/EC. Copper coated flakes should be attributed the symbol Xn: harmful and the Risk Phrase R22: Harmful if swallowed.
The results are considered as applicable to the "coated copper flakes" .
Executive summary:

The test material identity was not provided in details. Considering the information from the reports on the same material, the tested material falls in the composition category of "coated copper flakes" (see– section 1.2), consistent with a biocidal product use (PBD notification was the reason for doing the test).

The acute oral LD50 of the test material in the rat was estimated to be in the range of 300 - 500 mg/kg bw.

The test material meets the criteria for classification as harmful according to Annex VI of Commission Directive 2001/59/EC. The test substance should be attributed the symbol Xn: harmful and the Risk Phrase R22: Harmful if swallowed.