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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:
1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River, Margate, Kent, UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: males 217-246g, females 206-223g
- Fasting period before study: overnight
- Housing: in groups of 3 by sex in solid - nfloor polypropylene cages furnished with wood flakes.
- Diet: Rat and Mouse expanded diet number 1, ad libitum
- Water: mains water, ad libitum
- Acclimation period: minimum of 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-28
- Humidity (%): 49-75
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: suspension in arachis oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 200mg/ml
- Justification for choice of vehicle: Arachis oil BP was used as the test material did not dissolve or suspend in distilled water or other aqueous vehicles


MAXIMUM DOSE VOLUME APPLIED: 10ml/kg

Doses:
2000 mg/kg
No. of animals per sex per dose:
3M initially followed when it appeared the males would  survive by 3F, fasted
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The rats were observed for clinical signs of toxicity and  mortality 30 minutes, 1, 2 and 4 hours after dosing and thereafter daily  throughout the observation period. Body weights were recorded prior to  dosing on day 0 and then at 7 and 14 days. 
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no deaths.
Clinical signs:
No clinical signs of systemic toxicity.
Body weight:
All animals  showed the expected body weight gain over the observation period except  for one female which showed a weight loss during the second observation  week. This was considered unlikely to be a toxicological effect.
Gross pathology:
Unremarkable
Other findings:
None reported (no sex specific differences, no potential target organs identified).

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The rat oral LD50 for Kalcol 220-80 is >2000 mg/kg. There were no signs of intoxication and no remarkable findings on gross necropsy.
Executive summary:

In the acute oral toxicity study, 2000 mg/kg of test material in arachis oil was administered orally to 3 male and 3 female rats. The rats were observed for clinical signs of toxicity at 30 minutes, 1, 2 and 4 hours after dosing and thereafter daily throughout the 14 -day observation period. Body weights were also recorded prior to dosing on day 0 and then at 7 and 14 days. Necropsy of survivors was performed at the end of the 14 -day study period and macroscopic changes were noted.

No deaths were recorded throughout the observation period. No clinical signs of systemic toxicity were noted and there were no macroscopic abnormalities at necropsy. The study reports an LD50 value of > 2000 mg/kg bw. The study was conducted according to an appropriate OECD test guideline, and in complance with GLP.