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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
19 Oct 2004 - 16 Dec 2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Meets national standard methods; GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Remarks:
Product Safety Laboratories
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): AgSil TM 25 Potassium silicate solution
- Physical state: claer to hazy white, thick liquid
- Composition of test material, percentage of components: 70% water, 30% silicic acid, potassium salt, potassium silicate
- Lot/batch No.: C052804K1
- Stability under test conditions: stable for the duration of testing
- Storage condition of test material: at room temperature
- Other: ratio: 2.47; specific gravity: 1.231 g/mL

Test animals

Species:
rat
Strain:
other: Sprague-Dawley derived albino
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Ace Animals Inc., Boyertown
- Age at study initiation: 8 -9 weeks
- Weight at study initiation: 251 - 280 g (males) and 175 - 210 g (females)
- Housing: sngly in stainless steel cages
- Diet (e.g. ad libitum): Purina Rodent Chow #5012
- Water (e.g. ad libitum): filtered tap water
- Acclimation period: 8 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 22
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 20 Oct To: 3 Nov 2004

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsal area and the trunk
- % coverage: 10 (2 inches x 3 inches)
- Type of wrap if used: Durapore tape


REMOVAL OF TEST SUBSTANCE
- Washing (if done): the test sites were gently cleansed
- Time after start of exposure: 24 h


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.71 - 1.1 mL depending on body weight
- Concentration (if solution): 30%
Duration of exposure:
24 h
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: frequently during the first sevral hours after application and at least once daily thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw

Any other information on results incl. tables

All animals survived, gained body weight and appeared healthy and active. Apart from the dermal irritation (erythema) and alopecia noted at the application site of five animals (4 females and 1 male) between days 1 and 8, there were no other signs of toxicity. No gross lesions were observed at final necropsy in any animal.

Applicant's summary and conclusion