Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well performed OECD study with GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
purity: 99.7 %

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Kastengrund, SPF-Zucht strain: Hoe: WISKf(SPF71)
- Age at study initiation: males: about 7 weeks; females: about 8 weeks.
- Weight at study initiation: males: 197 - 201 gr; femals: 180 - 195 gr
- Fasting period before study: 16 hours
- Housing:in completely air conditioned rooms in macrolone cages in groups of 5 animals
- Diet: Rattendiät Altromin 1324, (Altromin-GmbH, Lage/Lippe), ad libitum (e.g. ad libitum):
- Water: tap water out of plastic bottles ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+-3
- Humidity (%): 50+-20
- Photoperiod: 12 hrs dark / 12 hrs light

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 2% starch
Details on oral exposure:
dose: 2000 mg/kg bw
concentration in vehicle: 20% (w/v)
application volume: 10 ml/kg bw
Doses:
2000 mg(kg bw
No. of animals per sex per dose:
5 males, 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: daily and weighing: once a week
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Preliminary study:
Doses: 500, 1000 and 2000 mg/kg bw
1 male and 1 female per dose
no letality, no impact on the developmnent of the body weight
Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD0
Effect level:
2 000 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
LD0
Effect level:
2 000 mg/kg bw
Based on:
test mat.
Mortality:
no
Clinical signs:
squatting posture, hollow flanks,decreased spontaeous activity,bristling coat, irregular respirate, uncoordinated gait.
Body weight:
no impact on the development of the body weight

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Since LD50>2000 mg/kg bw the substance is not subject for classification for acute oral toxicity.
Executive summary:

The substance was tested for acute oral toxicity accordng to OECD guideline 401. 5 male and 5 female Wistar-rats got a single dose of 2000 mg/kg bw by gavage. After the application no mortality occured. Only at the day of application the animals showed unspecific symptoms such as impact on the respiration and the movement. But these symptoms were reversible on the next day The development of the body weight was also normal. The LD50 for acute oral toxicity is therefore greater than 2000 mg/kg bw.