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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from June 1978 to July 1978
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Carbon black
EC Number:
215-609-9
EC Name:
Carbon black
Cas Number:
1333-86-4
Molecular formula:
C
IUPAC Name:
Carbon black
Test material form:
solid: nanoform, no surface treatment

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: S. Ivanovas GmbH & Co., Med. Versuchstierzuchten K.G., Kißlegg/Allgäu, Germany
- Age at study initiation: 38 days (male), 42 days (female)
- Weight at study initiation: 100 -105 g
- Fasting period before study: 15-16 hours
- Housing: single, in Makrolon cages
- Diet (e.g. ad libitum): ad lib
- Water (e.g. ad libitum): ad lib
- Acclimation period: not reported

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 0.5
- Humidity (%): 55 +/- 5
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): not reported

IN-LIFE DATES: From: June 1978 To: Jui 1978

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: aqueous hydroxypropyl methyl cellulose (0.8%)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: not reported (maximum technically achievable concentration)
- Amount of vehicle (if gavage): 50 mL/kg
- Justification for choice of vehicle:

MAXIMUM DOSE VOLUME APPLIED: not reported
Doses:
8000 mg/kg bw (maximum technically achievable concentration)
No. of animals per sex per dose:
20
Control animals:
no
Details on study design:
TEST ANIMALS: 10 male and 10 female Sprague-Dawley rats, from Ivanovas GmbH & Co., Kisslegg/Allgäu), weight between 100 and 105 g. Age at study begin: 38 days (male animals), 42 days (female animals). Animals were fed standard laboratory diet (Altromin), water was available ad libitum. Animals were held individually in macrolon cages in an air-conditioned room at 22 +/- 0.5 deg centigrade, and a relative humidity of 55% +/- 5%. EXPOSURE TO TEST SUBSTANCE: The test substance was applied via single gavage as suspension in 0.8% aqueous hydroxypropyl methyl cellulose E4M in a constant volumne of 50 mL/kg bw. Food was withdrawn 15-16 hours before administration of the test substance. POST EXPOSURE OBSERVATION PERIOD: 4 weeks. OBSERVATIONS/PARAMETERS: behaviour, food consumption, body weight gain. All animals were necropsied and macroscopically evaluated at the end of the post-observation period.
Statistics:
Not performed

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 8 000 mg/kg bw
Mortality:
There was no mortality.
Clinical signs:
There were no clinical signs of toxicity.
Body weight:
Food consumption was reduced 0, 4, and 6% at days 1, 2, and 14, respectively. Body weight gain was reduced 2, 4, and 4% at days 1, 2, and 14, respectively.
Gross pathology:
Findings at necropsy were unremarkable
Other findings:
Post-dose observation time was 4 weeks. There were no effects with regard to the behaviour of the animals.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral LD50 value in rats is greater than 8000 mg/kg bw (maximum achievable concentration)
Executive summary:

No mortality and no signs of toxicity occured in a OECD 401 guideline study with rats at 8,000 mg/kg bw. Necropsy findings were unremarkable.

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