GASIR1

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2011-07-20 to 2011-08-03

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Details on test material:

- Name of test material (as cited in study report): GASIR1
- Substance type: active substance
- Physical state: red-brown powder
- Analytical purity: 100%
- Composition of test material, percentage of components: 22% Germanium, 20% Arsenicum, 58% Selenium
- Purity test date:01/07/2011
- Lot/batch No.:3034-2
- Expiration date of the lot/batch: 30 June 2013:
- Stability under test conditions:no data
- Storage condition of test material: Room temperature (15-30°C) under nitrogen

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source:Laboratoire Elevage Janvier, B.P. 4105, Route des Chênes Secs, 53940 Le Genest-St-Isle CEDEX France
- Age at study initiation: Young adult rats
- Weight at study initiation: between 210 and 272g
- Housing: individual caging
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.1-24 °C
- Humidity (%): 42-69%
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12hrs dark/12hrs light

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

other: none

Details on dermal exposure:

TEST SITE
- Area of exposure:10% of the total body surface
- % coverage: 100%
- Type of wrap if used: semi occlusive plastic wrap

REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed after exposure (24h) with water of body temperature
- Time after start of exposure: 24h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000mg/kg bw
- Constant volume or concentration used: yes
- For solids, paste formed: no, the test item was placed onto a gauze pad and moistened with water

VEHICLE
- Amount(s) applied (volume or weight with unit): one gauze pad
- Lot/batch no. (if required): 102/26

Duration of exposure:

24h hours

Doses:

2000mg/kg bw

No. of animals per sex per dose:

5 animals/sex

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:Clinical observation: 1, 5 hours after treatment, then daily for 14 days. Body weighing: day 0, 7, 14
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

approximate LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occured after a 24 hour dermal exposure to GASIR 1 followed by a 14-day observation period

Clinical signs:

other: No clinical signs were observed

Other findings:

Small testes or epididymides, pelvic dilatation of the left kidney and luminal dilatation of the uterine horns were incidentally seen at necropsy.
Local dermal signs: Russet staining was recorded on the skin in all animals after dosing. The discoloration of the skin lasted up to day 4 in the male and day 8 in the female animals. No other local dermal signs were observed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute dermal median lethal dose (LD50) of the test item GASIR was found to be higher than 2000mg/kg body weight in male and female RjHan:(WI) Wistar rats.

Executive summary:

An acute dermal toxicity study was performed with test item GASIR1 in RjHan:(WI) Wistar rats, in compliance with OECD Guideline No.: 402.

A limit test was carried out at 2000mg/kg body weight (bw) in both sexes (5 rats/sex). The test item was applied as supplied, moistened with water, as a single dermal 24-hour exposure followed by a 14-day observation period.

Clinical observations were performed on all animals at 1 and 5 hours after dosing and daily for 14 days thereafter. Body weight was measured prior to dosing on Day 0 and on Days 7 and 14. Rats were euthanized and a gross macroscopic examination performed at the end of the 2-week observation period (Day 14).

The results of the study were summarized as follows:

Mortality

No mortality occurred.

Systemic clinical signs

No clinical signs were observed after the treatment with the test item or during the 14-day observation period.

Local dermal signs

No local dermal signs were observed during the entire study period. However, russet staining was observed on the skin in all animals after dosing from Day 1 to Day 4 in the males and Day 1 to Day 8 in the female animals.

Body weight

The body weight and body weight gain of GASIR1 treated animals did not show any test item-related effect.

Necropsy

There was no evidence of the test item-related observations at a dose level of 2000 mg/kg bw at necropsy. Small testes or epididymides, pelvic dilatation of the left kidney and luminal dilatation of the uterine horns were incidentally seen.

Conclusions

The acute dermal median lethal dose (LD50) of the test item GASIR1 was found to be higher than 2000 mg/kg bw in male and female RjHan:(WI) Wistar rats.