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:
guideline study
Remarks:
In Accordance with GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Purity > 98 %

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Ace Animals, Boyertown, PA, USA.
- Age at study initiation: Not specified.
- Weight at study initiation: Males, 265 - 270 g; females, 205 - 239 g.
- Fasting period before study: 16 - 20 hours.
- Housing: 3/sex/cage.
- Diet (e.g. ad libitum): PMI Rat Chow, ad libitum.
- Water (e.g. ad libitum): Ad libitum.
- Acclimation period: At least 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not specified.
- Humidity (%): Not specified.
- Air changes (per hr): Not specified.
- Photoperiod (hrs dark / hrs light): 12-hours light/dark.
IN-LIFE DATES: From: March 25, 2009 To: April 16, 2009

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 2% methyl cellulose
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3 per sex/dose
Control animals:
no
Details on study design:
Three male and three female Wistar rats were dosed orally with the test item at 2000 mg/kg bw. The animals were observed for 0.5, 1, 2, 3 and 4 hours post-dose and then once daily for 14 days (males) or 19 days (females) for mortality, toxicity and pharmacological effects. Body weights were recorded at intervals to termination. All animals were examined for gross pathology on termination.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
other: Acute Tox Class
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no mortalities.
Clinical signs:
Rigid muscle tone, abnormal gait, ataxia and soiling / wetness of the anogenital area were observed on day 1.
Body weight:

Body weight was unaffected in 4/6 animals. One female lost weight between days 7 and 19 of the observation period, while a second female lost weight between days 14 and 19.
Gross pathology:
All necropsy results were normal.

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 was greater than 2000 mg/kg bw in rats. Accordingly, the test item was considered to be in Acute Toxic Category 5 or unclassified.
Executive summary:

Three male and three female Wistar rats were dosed orally with the test item at 2000 mg/kg bw. The animals were observed for 0.5, 1, 2, 3 and 4 hours post-dose and then once daily for 14 days (males) or 19 days (females) for mortality, toxicity and pharmacological effects. Body weights were recorded at intervals to termination. Body weight changes were normal in 4/6 animals. One female lost weight between days 7 and 19. Another female lost weight between days 14 and 19. All animals were examined for gross pathology on termination. Necropsy results were normal.

The LD50was greater than 2000 mg/kg bw in rats. Accordingly, the test item was considered to be in Acute Toxic Category 5 or unclassified.