Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2007-07-02 to 2007-09-23
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Guideline Study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
December 2001
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland GmbH; D-97633 Sulzfeld
- Age at study initiation: no data
- Weight at study initiation: 166 - 177 g
- Fasting period before study: over night
- Housing: transparent macrolon cages (type 3-180, floor area 810 sq.cm), two or three animals in each cage;
- Diet: pelleted complete rodent diet, Altromin 1314; Altromin GmbH, D-32791 Lage, Lippe, Germany
- Water: domestic quality drinking water, acidified with hydrochloric acid to pH 2.5 in order to prevent microbial growth
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity: at least30 %; not exceeding 70 %
- Air changes: 10 times per hour
- Photoperiod: 12 hours light, 12 hours dark from 6 am to 6 pm

IN-LIFE DATES: From: 2007-07-03 To: 2007-07-24

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
The test item was administered orally by gavage to rats fasted over night prior to dosing. After dosing diet was witheld for 4 more hours. Dosing in the study took place on July 4th, 2007 between 7:10 and 7.20 am and on July 10th, 2007 between 9:00 and 9.10 am.
The study was carried out with two groups consisting of three female animals each given a dose of 2000 mg/kg bw. The start of the first group was on July 3rd, 2007. The start of the second group was on July 9th, 2007.
The dose volume administered was 10 mL/kg bw.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
2 dose groups of 3 females per dose group
Control animals:
no
Details on study design:
- Duration of observation period following administration: Each rat was observed 30 min, 2, 4 and 6 hours after administration of the test item and thereafter daily for aperiod of 14 days
- Frequency of observations and weighing: observations: daily; weighing : on day 0, 7, and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Statistics:
NA

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
Neither animals of the first group nor of the second group died on account of the treatment nor did they show severe signs of toxicosis.
Clinical signs:
First group; female: Animals No.1, No.2 and No. 3 showed piloerection 30 min and 2 hours after the application of the test item. After 4 hours and 6 hoursas well as from day 1 to the end of the observation period on day 14 no abnormalities were observed.
Second group; female: Animals No.4, No.5 and No. 6 showed piloerection 30 min and 2 hours after the application of the test item. After 4 hours and 6 hours as well as from day 1 to the end of the observation period on day 14 no abnormalities were observed.
Body weight:
The rats had a normal body weight gain during the study period.
Gross pathology:
The gross necropsy revealed no pathological abnormalities.
Other findings:
None

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance was not toxic after oral application.
Executive summary:

The test substance was investigated for its oral toxicity in accordance with OECD guideline 423 in female rats. No deaths occured until the end of the 14 day observation period. Only minimal and transient indisposition was observed during the first 4 hours after application. the test substance is not toxic after oral application.