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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1993
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Reference
Reference Type:
publication
Title:
Oral toxicity
Year:
1993
Bibliographic source:
Echa website

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS:
- Source: Dr. K. Thomae GmbH, 7950 Biberach, FRG
- Age at study initiation: young adults
- Weight at study initiation: mean 220 g (males), 191 g (females)
- Fasting period before study: 16 hours before administration, but water was available ad libitum
- Housing: five per cage in stainless steel wire mesh cages, type DK III (Becker & Co., Castrop-Rauxel, FRG)
- Diet (e.g. ad libitum): Kliba-Labordiät,Klingentalmühle AG, CH-4303 Kaiseraugst, Switzerland; ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS:
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Doses:
5000 mg/Kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: recording of signs and symptoms several times on the day of administration, then at least once each workday. Check for moribund and dead animals twice each workday and once daily at weekends and on holidays. Body weights were recorded shortly before administration and on day 3,7 and 13
- Necropsy of survivors performed: yes
- Other examination performed: clinical signs, body weights

Statistics:
LD50 was calculated according to Probit or other suitable methods.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occured
Clinical signs:
Black feces on days 1-3
Body weight:
Mean body weights (g) on days 0/3/7/13:
- Males: 220/260/289/325
- Females: 191/208/222/232
Gross pathology:
No abnormalities detected

Applicant's summary and conclusion

Interpretation of results:
other: Pratically non toxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance was tested for acute toxicity oral following OECD 401. This limit test study shows that the LD50 (rat/oral) is > 5000 mg/kg bw.No mortality or gross pathological changes were observed.