Registration Dossier

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study meets generally accepted scientific standards with restrictions due to the limited documentation.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1972
Report Date:
1972

Materials and methods

Principles of method if other than guideline:
BASF internal standardized test: Aqueous preparations of the test substance were injected into the peritoneal cavity of the mice. Group-wise documentation of clinical signs was performed over the 7-day study period. Body weight was determined before the start of the study only, as it was needed for determination of dose. The clinical signs and findings were reported in summary form.
GLP compliance:
no
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Golpanol BEO = Golpanol SC 9189
- Physical state: liquid
- Analytical purity: no data

Test animals

Species:
mouse
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Kisslegg, Germany
- Mean body weight at study initiation: males 28.9 g, females 23.2 g

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
water
Details on exposure:
VEHICLE
- Concentration in vehicle: 16% (w/v)
- Form of application: aqueous suspension

MAXIMUM DOSE VOLUME APPLIED: 15.6 mL/kg bw


Doses:
729.6, 912.6, 1136, 1422.75, 1824 and 2280 mg/kg bw (conversion of original values (640, 800, 1000, 1250, 1600, 2000 mL/kg bw) using the density of 1.14 g/cm³)
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: Body weight was determined before the beginning of the study for dose calculation.
Observation of clinical signs was several times on the day of administration and once daily afterwards with the exception of weekends and on holidays.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 1 026 mg/kg bw
Based on:
test mat.
Remarks on result:
other: original value 900 µL/kg bw (conversion using the density of 1.14 g/cm³)
Mortality:
729.6 mg/kg bw: no deaths occured (males and females).
912 mg/kg bw: 3/10 animals (males: 3/5 animals died within 24 hours after treatment; females: 0/5 animals died).
1136.35 mg/kg bw: 6/10 animals (males: 4/5 animals died within 24 hours, 5/5 animals were dead at the end of the observation period of 7 days after treatment; females: 1/5 animals died within 24 hours after tretament).
1422.75 mg/kg bw: 7/10 animals (males: 5/5 animals died within 24 hours after treatment; females: 1/5 animals died within 24 hours after tretament and 1/5 within 48 hours, in total 2/5 females were dead at the end of the observation period).
1824 mg/kg bw: males: 8/10 animals (4/5 animals died within 24 hours after treatment, 5/5 animals were dead at the end of the observation period of 7 days; females: 3/5 animals died within 24 hours after treatment).
2280 mg/kg bw: males: 9/10 animals (4/5 animals died within 24 hours after treatment, 5/5 animals were dead at the end of the observation period of 7 days; females: 5/5 animals died within 24 hours after treatment).
Clinical signs:
After treatment accelerated breathing, stagger, scampered gait, shrunken flanks and cloudy eyes were observed. After half a day the animals of the 2280 mg/kg bw and 1824 mg/kg bw dose level showed partly abdominal position. On the following days crouching position, intermittent and accelerated breathing and partly closed eyes were noted. No abnormality was detected in surviving animals between the 4th and 7th day after treatment.
Gross pathology:
sacrificed animals: 1136.35 mg/kg bw: 2/4 females: liver: 2 pinhead sized necrosis
perished animals: 2280 mg/kg bw: 1/3 males: liver: loam-yellow-grey with nutmeg-like pattern indicate congestive hepatopathy.

Applicant's summary and conclusion