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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
19-OCT-2005 - 17-NOV-200 5
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report date:
2005

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
Dec 2001
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Version / remarks:
Jun 2004
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Version / remarks:
Dec 2002
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method

Test material

Constituent 1
Reference substance name:
-
EC Number:
479-300-2
EC Name:
-
Molecular formula:
unspecified
IUPAC Name:
7,14,25,32-tetraazaundecacyclo[21.13.2.2²,⁵.0³,¹⁹.0⁴,¹⁶.0⁶,¹⁴.0⁸,¹³.0²⁰,³⁷.0²⁴,³².0²⁶,³¹.0³⁴,³⁸]tetraconta-1(36),2(40),3,5(39),6,8(13),9,11,16,18,20,22,24,26(31),27,29,34,37-octadecaene-15,33-dione; 7,14,25,32-tetraazaundecacyclo[21.13.2.2²,⁵.0³,¹⁹.0⁴,¹⁶.0⁶,¹⁴.0⁸,¹³.0²⁰,³⁷.0²⁵,³³.0²⁶,³¹.0³⁴,³⁸]tetraconta-1(36),2(40),3,5(39),6,8(13),9,11,16,18,20,22,26(31),27,29,32,34,37-octadecaene-15,24-dione
Test material form:
solid: nanoform, no surface treatment
Details on test material:
- State of aggregation: solid, powder
- Particle size distribution (TEM): 30.3 nm (D50)
- Mass median aerodynamic diameter (MMAD): not specified
- Geometric standard deviation (GSD): not specified
- Shape of particles: spherical
- Surface area of particles: 16.8 m²/g
- Crystal structure: crystalline
- Coating: no
- Surface properties: not applicable
- Density: 1515 kg/m³ at 20°C
- Moisture content: refer to IUCLID chapter 1
- Residual solvent: refer to IUCLID chapter 1
- Activation: not applicable
- Stabilisation: not applicable
Specific details on test material used for the study:
- Physical state: Solid, black powder
- Analytical purity: > 99%
- Storage condition of test material: Room temperature

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: RCC Ltd, Laboratory Animal Services, CH-4414 Fuellinsdorf/Switzerland
- Age at study initiation: 12 to 14 weeks
- Fasting period before study: for approximately 18 to 19 hours (access to water was permitted). Food was provided again 3 hours after dosing.
- Housing: Individually in Makrolon type-3 cages with wire mesh tops and standard softwood bedding.
- Diet: Pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet, batch no .39/05 (Provimi Kliba AG, CH-4303 Kaiseraugst/Switzerland) ad libitum.
- Water: Community tap water from Füllinsdorf ad libitum.
- Acclimation period: Under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study .

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30-70 %
- Air changes (per hr): 10-15 air changes per hour.
- Photoperiod: 12 hours light and 12 hours dark
- music during the daytime light period.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: aqueous solution of 0.5 % w/v carboxymethyl cellulose
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 0.25 g/mL

MAXIMUM DOSE VOLUME APPLIED: The application volume was 20 mL/kg body weight.

Doses:
5000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: All animals were examined for clinical signs at approximately 30 minutes, 1, 2, 3 and 5 hours after treatment on day 1 and once daily during test days 2-15. Mortality/viability was recorded at approximately 30 minutes, 1, 2, 3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during days 2-15.
- Frequency of weighing: Body weights were recorded on day 1 (prior to administration) and on days 8 and 15.
- Necropsy of survivors performed: yes, All animals were killed at the end of the observation period by carbon dioxide asphyxiation and discarded after macroscopic examinations were performed. No organs or tissues were retained.
- Other examinations performed: clinical signs, body weight
Statistics:
No statistical analysis was used.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
All animals survived until the end of the study period.
Clinical signs:
other: The first treated animal was noted with slightly ruffled fur from the 2-hour reading to test day 5. Black feces were seen in the cage from the 5-hour reading to test day 4. All clinical signs were reversible and no longer evident from test day 6 to the en
Gross pathology:
No macroscopic findings were recorded at necropsy.

Any other information on results incl. tables

The median lethal dose of the test substance after single oral administration to female rats, observed over a period of 14 days is:

LD50 (female rat): greater than 5000 mg/kg body weight.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The median lethal dose (LD50) of the test compound after single oral administration to female rats, observed over a period of 14 days is greater than 5000 mg/kg body weight.
Executive summary:

In a GLP compliant OECD guideline study, three female HanRcc :WIST (SPF) rats, were treated with the test substance by oral gavage administration at a dosage of 5000 mg/kg body weight. The test item was diluted in an aqueous solution of 0.5 % w/v carboxymethyl cellulose at a concentration of 0.25 g/mL and administered at a volume dosage of 20 ml/kg, respectively. The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recorded. All animals were examined for clinical signs at approximately 30 minutes, 1, 2, 3 and 5 hours after treatment on day 1 and once daily during test days 2-15. Mortality/viability was recorded at approximately 30 minutes, 1, 2, 3 and 5 hours after administration on test day 1(with the clinical signs) and twice daily during days 2-15. Body weights were recorded on day 1(prior to administration) and on days 8 and 15. All animals were necropsied and examined macroscopically. All animals survived until the end of the study period. The first treated animal was noted with slightly ruffled fur from the 2-hour reading to test day 5. Black feces were seen in the cage from the 5-hour reading to test day 4. All clinical signs were reversible and no longer evident from test day 6 to the end of the observation period. The second treated animal was noted with slightly ruffled fur from the 30-minute to the 3-hour reading. This clinical sign was reversible and no longer evident from the 5-hour reading to the end of the observation period. The third treated animal was noted with slightly ruffled fur from the 30-minute to the 5-hour reading. This clinical sign was reversible and no longer evident from test day 2 to the end of the observation period. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were recorded at necropsy. Therefore, the LD50 (female rat) was determined to exceed 5000 mg/kg body weight.