Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
liquid: viscous

Test animals

Species:
rat
Strain:
Wistar
Remarks:
Bor:WISW
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Breeding Centre for Laboratory Animals, F. Winkelmann GmbH, Borchen, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: ca. 14 weeks
- Weight at study initiation: 230-298 gram (males) and 172 - 208 gram (females)
- Fasting period before study: not specified
- Housing: The rats were housed in groups of five, males and females separated in stainless steel
cages with wire-screen bottom and front.
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: 9 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±2 ºC
- Humidity (%): 40-70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: January 22, 1987 To: February 5, 1987

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 10.0 mL per kg body weight (similar to 9300 mg/kg)
Doses:
10.0 mL per kg body weight (similar to 9300 mg/kg)
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: weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 9 400 mg/kg bw
Based on:
test mat.
Mortality:
No mortality observed during the observation period
Clinical signs:
After treatment none of the test animals showed any signs of intoxication
Body weight:
The individual body weights on day 7 and 14 were normal for rats of this strain and age
Other findings:
Not performed

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The oral LC50 was found to exceed 10.0 mL per kg body weight (equivalent to 9400 mg/kg, considering a relative density of 0.94 g/cm3)
Executive summary:

The acute oral toxicity of Ketimine resin was examined in rats. The test substance was given undiluted by gavage, in one single dose of 10.0 mL per kg body weight to 5 male and 5 female rats. After treatment none of th rats showed any sign of intoxication. No deaths occured and all rats looked quite healthy throughout the observation period. The oral LD50 of ketimine resin was found to exceed 10.0 mL per kg body weight (equivalent to 9400 mg/kg, considering a relative density of 0.94 g/cm3).