Perchloric acid

Endpoint summary

Description of key information

Oral LD50 between 200 and 2000 mg/kg

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from 23 may 2003 to 02 dec 2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study, OECD 423 compliant

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

yes

Remarks:

Temperature sometimes outside the range defined in guideline, but without incidence on the study.

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

no

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS: rat, Sprague-Dawley Rj: SD (IOPS Han).
- Source: Janvier, Le Genest-Saint-Isle, France.
- Age at study initiation: 6 weeks old
- Weight at study initiation: mean body weight ± standard deviation of 186 ± 9 g for the males and 168 ± 3 g for the females.
- Fasting period before study: The animals were fasted for an overnight period of approximately 18 hours before dosing, but had free access to water. Food was given back approximately 4 hours after administration of the test item.
- Housing: The animals were housed in polycarbonate cages with stainless steel lid (48 cm x 27 cm x 20 cm). Each cage contained one to seven animals of the same sex during the acclimation period and three rats of the same sex and group during the treatment period.
Each cage contained autoclaved sawdust (SICSA, Alfortville, France). Sawdust is analysed by the supplier for composition and contaminant levels.
- Diet: free access to A04 C pelleted diet (SAFE, Villemoisson, Epinay-sur-Orge, France)
- Water: Drinking water filtered by a FG Millipore membrane (0.22 micron) was provided ad libitum.
- Acclimation period: at least 5 days before the beginning of the study.

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

IN-LIFE DATES: From 02 sept 2003 to 25 sept 2003

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

purified water

Details on oral exposure:

VEHICLE
- Concentration in vehicle:
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: most appropriate
- Purity: purified water prepared at CIT by reverse osmosis.

DOSAGE PREPARATION: the test item preparation was made freshly on the morning of administration by the CIT Pharmacy and any unused material was discarded that same day.

CLASS METHOD
- Rationale for the selection of the starting dose: As no information on the toxic potential of the test item was available, for animal welfare
reasons, the starting dose of 200 mg/kg was chosen.

Doses:

200 and 2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed frequently during the hours following administration of the test item, for detection of possible treatment-related clinical signs. Thereafter, observation of the animals was made at least once a day.
Type, time of onset and duration of clinical signs were recorded for each animal individually.
Time of death was recorded individually, in terms of the number of hours or days after dosing.
- Necropsy of survivors performed: yes
- Other examinations performed:
Clinical signs: yes
Body weight: The animals were weighed individually just before administration of the test item on day 1 and then on days 8 and 15.
Individual weights of animals found dead during the study were measured at necropsy when survival exceeded 24 hours and if no signs of "cannibalism" were present.
The body weight gain of the treated animals was compared to that of CIT control animals with the same initial body weight.
Macroscopic necropsy examination: All study animals were subjected to a macroscopic examination as soon as possible after death.
After opening the thoracic and abdominal cavities, a macroscopic examination of the main organs (digestive tract, heart, kidneys, liver, lungs, pancreas, spleen and any other organs with obvious abnormalities) was performed.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

200 - 2 000 mg/kg bw

Based on:

test mat.

Mortality:

At the 200 mg/kg dose-level, no mortality occurred.
At the 2000 mg/kg dose-level, all males died on day 1.

Clinical signs:

other: At the 200 mg/kg dose-level, no clinical signs occurred. At the 2000 mg/kg dose-level, hypoactivity or sedation, piloerection, dyspnea and unsteady gait were observed prior to death.

Gross pathology:

At necropsy, on day 1, a white coloration of the stomach, liver, spleen, kidneys and intestines was noted in all males given 2000 mg/kg.
On day 15, macroscopic examination of the main organs of the animals given 200 mg/kg revealed no apparent abnormalities.

Interpretation of results:

harmful

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Perchloric acid is harmful according to DSD 67/548/EC and CLP 1272/2008/EC criteria.

Executive summary:

In a study (CIT, 2003), the acute oral toxicity of the test item Perchloric acid was evaluated in rats according to OECD 423 (22 March 1996) guideline.

The test item was prepared in purified water and was administered by gavage, under a volume of 10 mL/kg, to groups of fasted Sprague-Dawley rats, at doses of 200 and 2000 mg/kg bw.

Clinical signs, mortality and body weight gain were checked for a period of up to 14 days following the single administration of the test item. All animals were subjected to necropsy.

At the 200 mg/kg dose-level, no clinical signs and no mortality occurred. At the 2000 mg/kg dose-level, all animals died on day 1; hypoactivity or sedation, piloerection, dyspnea and unsteady gait were observed prior to death. The overall body weight gain of the animals given 200 mg/kg was not affected by treatment with the test item. At necropsy, on day 1, a white coloration of the stomach, liver, spleen, kidneys and intestines was noted in all males given 2000 mg/kg. On day 15, no apparent abnormalities were observed in the animals given 200 mg/kg.

Under these experimental conditions, the oral LD50 of the test item Perchloric acid is comprised between 200 and 2000 mg/kg in male and female rats.

Perchloric acid is harmful according to DSD 67/548/EC and CLP 1272/2008/EC criteria.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Quality of whole database:

GLP study, OECD 423 compliant

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

In a study (CIT, 2003), the acute oral toxicity of the test item Perchloric acid was evaluated in rats according to OECD 423 (22 March 1996) guideline.

At the 200 mg/kg dose-level, no clinical signs, no effect on body weight gain and no mortality were observed.

At the 2000 mg/kg dose-level, all animals died on day 1; hypoactivity or sedation, piloerection, dyspnea and unsteady gait were observed prior to death. Necropsy showed a white coloration of the stomach, liver, spleen, kidneys and intestines.

Under these experimental conditions, the oral LD50 of the test item Perchloric acid is comprised between 200 and 2000 mg/kg in male and female rats.

As perchloric acid is a very strong acid (pH < 1), no study is required nor has been performed for acute dermal toxicity or inhalation.

Justification for selection of acute toxicity – oral endpoint
Study following the standard guidelines and GLP.

Justification for classification or non-classification

Based on the available study, Perchloric acid is harmful if swallowed according to DSD 67/548/EC and CLP 1272/2008/EC criteria.