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other: Non-GLP similar to guideline study, available as unpublished report, limitations in design and/or reporting buth otherwise adequate for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
Five Wistar rats per sex per dose were exposed via oral gavage. After an exposure period of 14 days, in which documentation on clinical signs was performed, all animals were necropsied.
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): MBDA

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dr. K.Thomae GmbH. D-7950 Biberach, FRG
- Weight at study initiation: mean 172 and 176 g, for males and females respectively
- Fasting period before study: 16 h
- Housing: 5 animals per cage, stainless steel wire mesh cages, type DK-III (Becker & Co., Castrop-Rauxel, FRG)
- Diet: ad libitum, Kliba-Labordiaet 343 (Klingentalmuehle AG CH-4303 Kaiseraugst, Switzerland)
- Water: ad libitum, tap water
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Air: air-conditioned rooms
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
olive oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 40 g/ 100 mL (w/v)
- Amount of vehicle (if gavage): 5 mL/kg
- Justification for choice of vehicle: test substance is insoluble in water
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 weighing: at day 0, 7 and 13
- Frequency of observations: Signs and symptoms several times on the day of administration, at least once each workday. Check for moribund and dead animals twice each workday and once on holidays.S
- 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:
No mortality observed in all exposed animals.
Clinical signs:
Diarrhea was observed 4 hours after exposure in male and female rats
Body weight:
Mean weight males: 172, 215, and 261g before exposure, at day 7, and at day 13, respectively.
Mean weight females: 176, 201, and 220g before exposure, at day 7, and at day 13, respectively.
Gross pathology:
No pathologic findings were noted in sacrificed animals.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information
Conclusions:
Under the conditions of this test, the LD50 was determined to be >2000 mg/kg bw.
Executive summary:

In an oral acute toxicity study performed similar to OECD 401, five Wistar rats per sex were exposed to 2000 mg/kg bw of the test substance dissolved in olive oil via oral gavage. After an observation period of 14 days the surviving animals were necropsied. Diarrhea was observed 4 hours after exposure. No mortality was observed. No pathologic findings were noted in sacrificed animals. The LD50 was determined to be > 2000 mg/kg bw.