Registration Dossier

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
limited data to test substance, read across substance

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Principles of method if other than guideline:
according to BASF-internal standard(s)
GLP compliance:
no
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: WILHELM GASSNER, SULZFELD
- Age at study initiation: 12 weeks
- Weight at study initiation: no data
- Housing: groups of 5
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 1 weeks
- Fasting: 16h before application

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-26
- Humidity (%): 45-75
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
0.5 % CMC solution + 1-2 drops of castor oil
Details on exposure:
2000 mg/kg bw
10 ml/kg bw

single injection intraparitoneal
Doses:
2000 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: immediately, days 2, 7 and 13
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
Dyspnea, apathy, staggering, ruffled fur, exsiccosis, poor general state
Gross pathology:
Sacrificed animals: intraabdominal substance incorporations; liver: truncated borders

Applicant's summary and conclusion