Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline with acceptable restrictions (mostly due to reduced reporting in times before GLP)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test-item: Golpanol SC 9269 = Golpanol ALS
- Batch identification: 04749356P0
- Purity: 25 % in aqua dest.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Gassner
- Mean weight at study initiation: 180 g (male), 160 g (female)

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: dest. water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 25 %
- Amount of vehicle (if gavage): 10000 µl/kg

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw
Doses:
100, 1000, 10000 µl/kg
No. of animals per sex per dose:
5 for the highest dose
2 females for the other doses
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Weighing was prior the beginning of the study for dose calculation, on day 3, 7 and 13. Observation of clinical signs was several times on the day of administration and once daily afterwards with exception of weekends.
- Necropsy of survivors performed: yes

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 10 mL/kg bw
Based on:
test mat.
Remarks on result:
other: 1/10 animals died at the highest dose tested
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: 1/10 animals died. at the highest dose tested (ca. 12300 mg/kg bw)
Mortality:
1/10 animals died one day after application of 10000 µl/kg bw. No mortality was observed in the other dose groups.
Clinical signs:
Sporadic dyspnoea, apathy and diarrhoea the first hours after administration of the test substance at the highest dose level.
Body weight:
The mean body weights of the animals were in the normal range throughout the study period.
Gross pathology:
Sporadic pneumotic areals in lungs were noted in the animals examined at termination of the study.

Applicant's summary and conclusion