Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented study report which meets basic scientific principles

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar 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
Details on test material:
- Name of test material (as cited in study report): FAT 66031/A
- Analytical purity: > 80%
- Physical state: solid
- Lot/batch No.: Op. 1/81

Test animals

Species:
rat
Strain:
other: Tif:RAif (SPF)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 7 to 8 weeks
- Body weights at study initiation: males - 175 g; females - 176 g
- Fasting period before study; overnight
- Housing: in groups of 5 in Macrolon cages (type 3)
- Diet: rat food NAFAG No. 890 NAFAG Gossau SG; ad libitum
- Water: tap water; ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Details on oral exposure:
VEHICLE
- Amount of vehicle (if gavage): 20 mL/kg body weight
Doses:
5000 mg/kg body weight
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
- Other examinations performed: clinical signs, body weights

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortality
Mortality:
No mortality occurred.
Clinical signs:
Dyspnoea reported at 1, 2, 3, 5, 24 hours and on days 2, 3, 4, 5, 6, 7, and 8.
Exophthalmos reported at 1, 2, 3, 5, 24 hours and on days 2, and 3
Ruffled fur reported at 1, 2, 3, 5, 24 hours and on days 2, 3, 4, 5, 6, and 7
Diarrhoea reported at 2 and 3 hours after dosing
Curved body position reported at 1, 2, 3, 5, 24 hours and on days 2, 3, 4, 5, and 6
Body weight:
Body weights and body weight gains were in the normal range.
Gross pathology:
No compound-related findings were reported.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral LD50 of the test substance in rats of both sexes observed over a period of 14 days is > 5000 mg/kg body weight.