[No public or meaningful name is available]

Acute Toxicity: oral

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

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

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 or test system 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:

other: 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.

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