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 study with acceptable restrictions (e.g. rel. low purity of test substance 86.3%)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
purity: 86.3%, white, odorless solid

Test animals

Species:
rat
Strain:
other: Bor: WISW (SPF Cpb)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:
- Age at study initiation: 6 to 8 week old
- Fasting period before study: 16 h
- Housing:separated by sex, max. 5 animals per Makrolon type III cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period:at least 5 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 30-70%
- Photoperiod: 12hrs dark / 12hrs light


I

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 30g/100cm3
- Amount of vehicle (if gavage):6.67 cm3/kg body weight
- Justification for choice of vehicle: corn oil was chosen because of low water solubility of test substance


Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5/sex
Control animals:
no
Details on study design:
- Duration of observation period following administration: 1/2, 1, 2, 3, 4, 5, and 6 h post application, once daily during the following 14 days
- Frequency of observations and weighing: day 0, day 7, day 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Preliminary study:
preliminary study: 2 males and 2 females were orally administered with 2000 mg/kg bw test substance
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels:
5 - 6 h post applicationem bei drei von fünf männlichen
Tieren kurzzeitig Diarrhoe. Ein weibliches Tier zeigte zu
diesem Zeitpunkt Hockhaltung und ein gesträubtes Fell. 24
und 48 h post applicationem wurde lediglich bei einem Tier
noch ein gesträubtes Fell beobachtet, 72 h post
applicationem war das Tier symptomfrei. Zwei männliche und
vier weibliche Tiere zeigten während der gesamten
Beobachtungsperiode keine Vergiftungssymptome. Die
Körpergewichtsentwicklung der Tiere während der gesamten
Versuchsdauer war normal.

"ENGLISH"

5 up to 6 hours after the application three of five male
test animals showed diarrhoe for a short time. A female
animal showed crouched posture and piloerection. 24 and 48
hours after the application only one animal showed
piloerection and 72 hours after the application the animal
was free of all symptoms. Two male as well as four female
animals showed no symptoms of toxicity during the whole
observation period. The body weight gain of the animals
developped normally during the whole test period.
Gross pathology:
Effects on organs:
Die Sektionen und makroskopischen Untersuchungen der Organe
am Versuchsende ergaben keine Hinweise auf substanzbedingte
Organveränderungen. Es wurden keine geschlechtsspezifischen
Toxizitätsunterschiede festgestellt.

"ENGLISH"

The sections and macroscopic investigations of the organs at
the end of the test showed no indications of substance
related changes of the organs and no sex-specific
differences in toxicity.

Any other information on results incl. tables

Mortality: males: 0/5, females 0/5

Clinical signs:

Five and six hours after the application three of five males showed diarrhea. A female animal showed squatting position and rough coat 5 and 6 h after application, and rough coat after 48 h. After 72 hours the animal was free of all symptoms. Two males as well as four females showed no symptoms of toxicity during the whole observation period.

The body weight gain of the animals developed normally during the whole test period.

Necropsies and gross pathology: no evidence of substance-related organ changes was found

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
LD50 was >2000 mg/kg bw.
Executive summary:

In a rat study, which was done under GLP and according to OECD guideline 401, the oral LD50 was >2000 mg/kg bw (Hüls AG 1992a). No effects were observed with regard to mortality, body weight gain and gross examinations. Three male rats showed diarrhoea five and six hours after application. One female showed squatting position and rough coat 5 and 6 hours after the application. After 48 hours only the rough coat was still present and no effects were seen after 72 hours. The other animals showed no symptoms of toxicity during the whole observation period.