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Description of key information

The study was performed on a tested substance with a higher content of active ingredient. 

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:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
fixed dose procedure
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS- Weight at study initiation: average male weight 196 g, average female weight 158 g- Age: 7 weeks- Fasting period before study: 22 h - Housing: single animale per cage- Diet: commercial pelleted diet (Oakes Special Diet with added Vit. C) ad libitum- Water: tap water ad libitum ENVIRONMENTAL CONDITIONS- Temperature (°C): 21 ± 2- Photoperiod (hrs dark / hrs light): 12 h light / 12 h dark
Route of administration:
oral: gavage
Vehicle:
water
Doses:
Single dose: 25% of solution of teh compound in tap water was administrated with a single dose by gavage to rate which had been fasted for 18 hours at a rate of 20ml/kg equivalent to 5000 mg/kg of the compound.
Control animals:
not specified
Statistics:
Not applicable.
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
act. ingr.
Mortality:
No mortality
Clinical signs:
Compound passed through the gastro intestinal tract within 12 hours of administration and some was still visible in the faeces after 24 hours.
Body weight:
No data.
Gross pathology:
No change in any organs and tissues.
Interpretation of results:
GHS criteria not met
Conclusions:
LD50 > 5000 mg/kg bw.
Executive summary:

The results show no toxicity with a LD 50 value > 5000 mg/kg.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Type of information:
other: read across from similar substance
Adequacy of study:
key study
Study period:
1994
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
according to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Version / remarks:
Reference from study report: OECD Guideline for Testing of Chemicals, 1981
GLP compliance:
yes
Remarks:
GLP declaration
Test type:
traditional method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: VELAZ Praha
- Females (if applicable) nulliparous and non-pregnant: yes
- Microbiological status of animals, when known:
delivered with veterinary attest “QUALITY STATUS” – no parazites, pathogen microorganisms, viruses or mold
- Age at study initiation: 8 weeks
- Weight at study initiation: tested animals; males: 170.8 ± 7.12 g; females: 161.2 ± 4.22 g
- Housing: 5 animals in 1 polypropylene cage T4 type, separated male/female
- Diet (e.g. ad libitum): granulated mixture Altromin 1320 (VELAZ Praha) 12g/animal/day
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 week as minimum
ENVIRONMENTAL CONDITIONS
Automatically controlled temperature, humidity and lighting
- Temperature (°C): 22±3
- Humidity (%): 40 – 60%
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12 /12
Route of administration:
inhalation: aerosol
Type of inhalation exposure:
head only
Vehicle:
air
Remark on MMAD/GSD:
Before starting the exposure a particle size of the initial sample was measured microscopically.
The size of the majority of particles was between 2- 4 µm.
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
6 h
No. of animals per sex per dose:
5 male/5 female
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
immediately after end of exposure, after 1st and 2nd hour, then daily
body weight was measured immediately before exposure, then on the 7th and 14th day


- Necropsy of survivors performed: yes
- Other examinations performed:
clinical signs, body weight, food and water intake, appearance of hair, skin and visible mucous membranes, somatomotor and mental activity, reaction to stimuli, focusing on sensibility and reactivity, lacrimation, functional assessment of the respiratory, circulatory, digestive and urogenital system


Key result
Sex:
male/female
Based on:
test mat.
Exp. duration:
6 h
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
no
Clinical signs:
other: Health condition clinical detection suggests mechanical irritation due to test substance on exposed mucous membranes of the upper respiratory tract, reduced airway patency and insufficient oxygen supply to vital organs.
Body weight:
see attached document
Gross pathology:
The results of the pathological-anatomical examination revealed a P-deposition of inhaled material particles without local or general response of the organism of animals tested.
Differences depending on the sex of the animals were not recorded. Reactions and autopsy findings were the same.
Interpretation of results:
GHS criteria not met
Conclusions:
No toxic effects observed.
Executive summary:

A limit test for acute inhalation toxicity with the tested substancewas conducted. The assay was performed according to OECD methodology No. 403. Experimental animals (10 rats Wistar) were exposed to an aerosol inhalation of the pulverized test substance for 4 hours in the inhalation chamber of "head only" type.

During the exposure and even during the 14 day observation period there was no death among tested animals.

Signs of intoxication were clinically determined and give an evidence of mechanical irritation of dust aerosols on exposed mucous membranes of the upper respiratory tract and decreased airway patency and insufficient oxygen supply to vital organs.

Pathological examination had demonstrated a focal infiltration of pulmonary tissues by test substance particles.

Health condition clinical detection suggests mechanical irritation due to test substance on exposed mucous membranes of the upper respiratory tract, reduced airway patency and insufficient oxygen supply to vital organs.

The results of the pathological-anatomical examination revealed a P-deposition of inhaled material particles without local or general response of the organism of animals tested.

Differences depending on the sex of the animals were not recorded. Reactions and autopsy findings were the same.

Limit test results revealed the P-deposition with test substance particles but showed no adverse effects on the health of experimental animals.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

No Adverse Effect level for acute toxicity oral is LD50 > 5000 mg/kg.
NOAEL value for acute inhalation was not determined due to the absence of effects during the test.

Justification for classification or non-classification

According to the CLP Regulation (EC n. 1272/2008), table 3.1.1, Acute toxicity hazard categories and acute toxicity estimates (ATE) defining the respective categories:

For Acute toxicity oral route:

Category 1: ATE <= 5 mg/kg bw

Category 2: 5 < ATE <= 50 mg/kg bw

Category 3: 50 < ATE <= 300 mg/kg bw

Category 4: 300 < ATE <= 2000 mg/kg bw

The LD50 of the test substance was determined to be > 2000 mg/kg bw in the chosen reference test, which is outside the above criteria.
There were no effects in the acute inhalation toxicity test.

Therefore, the test substance is not classified for Acute toxicity by oral exposure and inhalation.

No classification for acute toxicity oral is warranted under Regulation 1272/2008.

No classification for acute toxicity inhalation is warranted under Regulation 1272/2008.

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