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Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
other: experimental study on simlar substance
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:
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 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

Endpoint conclusion
Endpoint conclusion:
no study available

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.