Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
(1996)
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
The test substance was tested in solution approx. in 75 % in 2−Methoxy−1−methylethylacetate/Solventnaphtha 100 (8:17)
Appearance: colourless to yellowish liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Strain: Hsd Cpb:WU, SPF-bred
- Source: Harlan Winkelmann, Borchen, Germany
- Age at study initiation: 7-8 weeks old
- Weight at study initiation: mean weight 199 g for males and 170 g for females
- Fasting period before study: yes, from 16 hours (over night) prior to at least 4 hours after application
- Housing: in goups of 3 animals in Makrolon® Type-III cages on low-dust wood granules
- Diet and Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 5
- Air changes (per hr): 15 to 20
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Details on oral exposure:
Application volume: 10 mL/kg bw
The test substance was formulated in the application vehicle (polyethylene glycol 400) immediately prior to treatment.
Doses:
2000 mg/kg bw test item, which is 75 % in solvent. Thus, based on the active ingredient the dose was 1500 mg/kg bw.
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: several times on the day of administration, and at least once daily during the observation period.
- Frequency of weighing: directly before administration, after one week and at the end of the observation period or after death.
- Necropsy of survivors performed: yes
Statistics:
Statistical evaluation of the data related to body weights was performed using SAS® routines. The variables are described by sex, dose group and date using appropriate measures of central tendency (mean) and general variability (standard derivation). An estimation of the median lethal dose (LD50) on the basis of the flow charts given in the guideline was done.

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 1 500 mg/kg bw
Based on:
act. ingr.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: 75 % substance in solvent
Mortality:
No animal died after administration of the substance.
Clinical signs:
After administration of the substance no clinical signs were observed.
Body weight:
Body weight development of male and female rats was not affected.
Gross pathology:
None of the animals sacrificed at the end of study showed any noticeable gross pathological findings.
Other findings:
None

Applicant's summary and conclusion

Executive summary:

An acute oral toxicity study according to OECD TG 423 was conducted with a limit dose of 2000 mg/kg test item administered to 3 male and 3 female rats. The content of the substance in the test item was 75 %, therefore the actual limit dose was 1500 mg/kg bw based on active ingredient.

No animal died in the course of the study and no clinical signs were observed after administration of the test item. Body weight development was not affected. The animals sacrificed at the end of study showed no noticeable gross pathological findings. The LD50 was estimated to be > 2000 mg/kg bw for the test item, correlating to > 1500 mg/kg bw for the active ingredient.