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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Publication, not a full study report, GLP. However, the study has apparently been conducted in accordance with OECD 423 and relevant experimental details and results are reported.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2013

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
2001-12-17
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: nanoform
Details on test material:
- Name of test material (as cited in study report): Ag-NPs (silver nanoparticles)(obtained from ABC Nanotech Co., Ltd. (Daejeon, Korea))
- Product name: SARPU 200KW (nano-sized colloidal silver)
- Physical state: black colloid
- Concentration in stock solution: 20.48%
- Lot No.: SL-132B4DD01
- Viscosity (cps): <15
- Specific gravity (at 25°C): 1.2
- Average particle size: 10.0 nm
- Particle surface area (mean): 3.18 x 10^2 mm^2/particle; 54.88 m^2/g
- pH: 5.80

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Koatec Co. Ltd. (Pyeongtaek, Korea)
- Age at study initiation: 8-week-old
- Weight at study initiation: 300 mg/kg: 159.03 ± 3.84 (1st step) and 164.43 ± 3.02 (2nd step); 2000 mg/kg: 153.00 ± 3.74 (1st step) and 159.40 ± 5.47 (2nd step)
- Housing: three animals were housed per cage, plus during the administration and observation periods, no more than three animals were housed in a wire cage.
- Diet (ad libitum): commercial rodent chow (TEKLAD CERTIFIED GLOBAL 18% PROTEIN RODENT DIET, 2918C Harlan Co. Ltd., Indianapolis, IN, USA
- Water (ad libitum): tap water sterilised by ultra-violet irradiation
- Quarantine and acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature: 23 ± 3°C
- Relative humidity: 55 ± 15%
- Air changes: 10 - 20 air changes per hour
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 1% citric acid
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

DOSAGE PREPARATION:
The AgNPs were dispersed in 1% citric acid.

CLASS METHOD
- Rationale for the selection of the starting dose: due to the absence of any toxicity data on the test substance, the dose level for the first step was 300 mg/kg (dosing volume were 10 mL/kg).
Doses:
300 and 2000 mg/kg
No. of animals per sex per dose:
6 rats (3 rats per step)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days (daily)
- Frequency of observations and weighing: the mortality, clinical signs, body weights and necropsy findings were observed. The body weights were recorded on day 1, 3, 7 and 24.
- Necropsy of survivors performed: yes
Statistics:
The statistical analyses were performed using SPSS 12.1, Chicago, IL, USA and the data expressed as the mean ± SD. A chi-square test and one-way analysis of variance (ANOVA) were applied to test all the data. A value of p < 0.05 indicated statistical significance.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 other: mg/kg
Based on:
test mat.
Mortality:
300 and 2000 mg/kg: no deaths occurred
Clinical signs:
300 and 2000 mg/kg: normal appearance
Body weight:
300 and 2000 mg/kg: there were no significant differences in the body weights during 14 days after administration.
Gross pathology:
300 and 2000 mg/kg: no abnormal gross findings at necropsy.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 (female rats) > 2000 mg/kg
According to the EC-Commission directive 67/548/EEC and its subsequent amendments, the test substance is not classified as acute toxic via the oral route.
According to the EC-Regulation 1272/2008 and subsequent regulations, the test item is not classified as acute toxic via the oral route.