Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline Study under GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

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

Test material

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

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hoechst Aktiengesellschaft, Kastengrund, SPF breeding colony
- Species: Wistar Rat
- Strain: Hoe: WISKf(SPF71)
- Age at study initiation:
male animals approximately 7 weeks
female animals approximately 8 weeks
- Weight at study initiation:
males: mean = 178 g, SD = 7, xmin = 171, xmax = 188, n=5
females: mean = 173 g, SD = 7, xmin = 155, xmax = 186, n=20
Animal maintenance: in fully air-conditioned rooms in macrolon cages (type 4) on soft wood granulate in groups of 5 animals
Room temperature: 22 ± 3 °C
Relative humidity: 50 ± 20 %
Lighting time: 12 hours daily
Food: ad libitum
Withdrawal of food: from about 16 hours before to 3 - 4 hours after treatment
Water: tap water in plastic bottles, ad libitum
Animal identification: fur marking and cage numbering

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
deionized
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 20%
- Amount of vehicle (if gavage): sesame oil
- Doses applied:
2000 mg/kg bw (males)
2000 - 1600 - 1250 - 1000 mg/kg bw (females)
MAXIMUM DOSE VOLUME APPLIED:
10 ml (20% solution) = 2000 mg/kg bw
Doses:
4
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: daily
- Necropsy of survivors performed: yes
Statistics:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 481 mg/kg bw
Based on:
test mat.
Mortality:
Lethality occurred up to day 4 of the study.
Clinical signs:
The following unspecific clinical signs of intoxication were noted: irregular respiration, decreased and increased spontaneous activity, prone position, trembling, uncoordinated gait, narrowed palpebral fissure, increased fright reaction, decreased body surface temperature, clear colourless lacrimation, swollen abdomen and diarrhea.
Body weight:
Not impaired
Gross pathology:
Necropsy of the decedent animals revealed light discoloured liver and kidneys, lobular demarcation of the liver, stomach with petechial bleedings and detachment of the mucosa, red or orange discoloured lungs, urinary bladder taut with dark yellowish fluid, and blood and yellowish mucous in the small intestine.
The animals killed at the end of the observation period showed no macroscopically visible changes.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The acute oral toxicity testing of the test material in the Wistar rat yielded the following median lethal dose (LD50):
Female animals: 1481 mg/kg body weight
Male animals did not show a higher sensitivity to the test substance.
Executive summary:

The acute oral toxicity testing of the test material in the Wistar rat yielded the following median lethal dose (LD50):

Female animals: 1481 mg/kg body weight

Male animals did not show a higher sensitivity to the test substance.

The observation period following application was 14 days. Lethality occurred up to day 4 of the study. The following unspecific symptoms were observed: impairments of respiration, motility, consciousness and reflexes, prone position, trembling, narrowed palpebral fissure, increased fright reaction, decreased body surface temperature, clear colourless lacrimation, swollen abdomen and diarrhea. On day eight of the study the clinical symptoms had reversed in the surviving animals.

Development of body weight was not impaired.

Necropsy of the decedent allimals revealed light discoloured liver and kidneys, lobular demarcation of the liver, stomach with petechial bleedings and detachment of the mucosa, red or orange discoloured lungs, urinary bladder taut with dark yellowish fluid, and blood and yellowish mucous in the small intestine.

The animals killed at the end of the observation period showed no macroscopically visible changes.