Registration Dossier

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals

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

Administration / exposure

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.

Results and discussion

Effect levels
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.

Applicant's summary and conclusion

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.