Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
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:
- Name of test material: IUPAC: Hydrogen bis (4-(5-chloro-2-hydroxyphenalazo)-5-methyl-2-phenyl-2H-pyrazol-3-olato)ferrate; CAS: Ferrate(1-), bis(4-(2-(-chloro-2-(hydroxy-.kappa.O)phenyl)diazenyl-.kappa.N1)-2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)-.kappa.O3)-, hydrogen (1:1)
- Substance type: toner additive; charge control agent
- Physical state: solid
- Analytical purity: 98.02% (HPLC)
- Impurities (identity and concentrations): unknown: 0.98% (HPLC); water: 1.0%
- Composition of test material, percentage of components: ---
- Isomers composition: ---
- Purity test date: 5-Oct-07
- Lot/batch No.: 002-2
- Expiration date of the lot/batch: 2-Oct-09
- Stability under test conditions: stable
- Storage condition of test material: dry, cool; under exclusion of light
- Other: ---

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland
- Age at study initiation: approx. 8 weeks
- Weight at study initiation: 163 g
- Fasting period before study: 16 h
- Housing: polycarbonate cages type III
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: 10 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):


IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Doses:
2000 mg/kg
No. of animals per sex per dose:
2x 3 rats
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: twice a day/twice a week
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
no

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
none
Clinical signs:
After treatment, the rats were carefully inspected regarding their general health status.
They showed slight signs of discomfort but no toxicity effects. The general health status was good.
Body weight:
No treatment-related effects observed
Gross pathology:
No abnormalities observed
Other findings:
None

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
UNCLASSIFIED (GHS)
Executive summary:

SUMMARY

·       Six female Wistar rats received a single oral gavage dose of the test item T-126 formulated in corn oil, and administered at a dose of 2000 mg/kg body weight.

·       None of the animals showed any clinical signs of reaction to treatment.

·       All animals showed a continuous increase of body weights throughout the study period.

·       All six animals were killed as scheduled at study termination (after a 14-day observation period).

·       The animals did not show any abnormalities upon macroscopic examination.

·       From the results observed in this acute oral toxicity study the following classification was derived for test item T-126: Unclassified (GHS system).

·       An LD50 was not determined in this study. An experimentally determined LD50 is estimated to be > 2000 mg/kg body weight.

Table 1              Summary of Results

Limit test with T-126

Treatment Group

Number of exposed rats

6

Number of rats showing affected reflexes

0 / 0 / 0

4/24/48 hrs after treatment

Mean of body temperature (° C) (SD)

4 hrs after treatment

37.6 (0.3)

Number of dead animals within 14-day post-observation period

0

Rats showing abnormalities in gross pathology on day 14 of post-observation period

0