Potassium perchlorate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Sodium perchlorate

EC Number:

231-511-9

EC Name:

Sodium perchlorate

Cas Number:

7601-89-0

Molecular formula:

ClHO4.Na

IUPAC Name:

sodium perchlorate

Details on test material:

- Name of test material (as cited in study report): Anhydrous Sodium Perchlorate
- Physical state: white powder
- Analytical purity: 98.21%
- Impurities (identity and concentrations): H2O 1.67%, ClO3 0.081%
- Purity test date: 10 January 2008
- Lot/batch No.: 10/01/08; Sponsor's filing No. GRL 0005/08
- Expiration date of the lot/batch: February 2010
- Storage condition of test material: Room temperature, keep hermatically closed. Store away from heat and ignition sources

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: 8 weeks
- Weight at study initiation: Males 367 ± 12g; Females 237 ± 7g
- Housing:
Acclimation period: 1 - 7 of same sex in polycarbonate cages with stainless steel lid (48x27x20cm).
Treatment period: individually housed in polycarbonate cages with stainless steel lid (35.5x23.5x19.3cm). Each cage contained autoclaved sawdust (SICSA, Alfortville, France).
- Diet: SSNIFF R/M-H pelleted maintenance diet (ad libitum); SSNIFF Spezialdiaten GmbH, Soest, Germany).
- Water: drinking water filtered by a FG Millipore memmbrane (0.22µm) ad libitum.
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 30-70%
- Air changes (per hr): 12 cycles/hr of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12h/12/h (7:00-19:00)


IN-LIFE DATES: From: 10 April 2008 To: 24 April 2008

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: Males approx. 5x7cm; Females approx. 5x6cm
- % coverage: approx. 10%
- Type of wrap if used: adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage.


REMOVAL OF TEST SUBSTANCE
- Removed using a dry cotton pad
- Time after start of exposure: 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): as a single dose at 2000mg/kg adjusted according to the bodyweight determined on the day of
treatment
- Concentration (if solution): Applied as its original formbut purified water was used in order to moisten the test item and ensure a good contact with the skin
- Constant volume or concentration used: yes
- For solids, paste formed: no


VEHICLE
Not applicable

Duration of exposure:

24 hours

Doses:

A single dose (2000 mg/kg bw)

No. of animals per sex per dose:

5 animals/sex/dose

Control animals:

not required

Statistics:

no

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD0

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths during the study

Clinical signs:

other: No systemic clinical signs were observed during the study. Crusts were noted in 1/5 males (No. 5) from day 10 until day day 15 (end of the observation period)

Gross pathology:

When compared to CIT historical control animals, a slightly lower bodyweight gain was noted in 1/5 females (No. 7) between day 1 and day 8; it returned to normal thereafter

Other findings:

None

Any other information on results incl. tables

No deaths and no systemic clinical signs were observed during the study . Crusts were noted in 1/5 males from day 10 until day 15. When compared to CIT historical control animals, a slightly lower body weight gain was noted in 1/5 females between day 1 and day 8; it returned to normal thereafter. The body weight gain of the other animals was not affected by treatment with the test item. No apparent abnormalities were observed at necropsy in any animal.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the experimental conditions of this study, the dermal LD50 of the test item was higher than 2000mg/kg in rats.

Executive summary:

The acute dermal toxicity of the test item ANHYDROUS SODIUM PERCHLORATE (batch No. lot moyen du 10/01/08 test) was evaluated in rats according to OECD (No. 402, 24th February 1987) and EC (92/69/EEC, B.3, 31st July 1992) guidelines. The study was conducted in compliance with the principles of Good Laboratory Practice Regulations. Under the experimental conditions of this study, the dermal LD0 of the test item ANHYDROUS SODIUM PERCHLORATE (batch No. lot moyen du 10/01/08 test) was higher than 2000 mg/kg in rats.