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)
Rationale for reliability incl. deficiencies:
other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Residues (petroleum), steam-cracked
EC Number:
265-193-8
EC Name:
Residues (petroleum), steam-cracked
Cas Number:
64742-90-1
IUPAC Name:
Residues (petroleum), steam-cracked
Constituent 2
Reference substance name:
carbon black oil
IUPAC Name:
carbon black oil
Details on test material:
- Name of test material (as cited in study report): carbon black oil
- Substance type: Mixture of high boiling aromatic hydrocarbons
- Physical state: dark brown liquid
- Analytical purity: not applicable
- Density : 1.03 - 1.11 g/cm3 at 288.7 K
- Boiling point (initial, average) : 428 K at 1 x 10E5 Pa
- Composition of test material: alicyclic- and arylbenzenes, bi- and tricyclic aromatic compounds, asphalthenes and other high boiling hydrocarbons.
Carbon Black Oil contains less than 3 weight-% of polycyclic aromatic hydrocarbons (PCA)
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
other: Wistar outbred rats (Crl:Wl(WU)BR)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Breeding Centre for Laboratory Animals "Charles River Wiga GmbH", Sulzfeld, F.R. Germany
- Age at study initiation: Approximately 6-7 weeks
- Weight at study initiation: 146 to 183 g for males, 123 to 141 g for females
- Fasting period before study: Yes (overnight)
- Housing: 5/cage, sexes separately, in stainless steel cages with wire-screen bottom and front
- Diet: TNO Institute's cereal-based, open-formula basal diet for rats ad libitum (except overnight prior to dosing)
- Water: Tap water ad libitum
- Acclimation period: Approximately 11 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20-24°C
- Humidity: 30-70%
- Air changes (per hr): 10
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: From: 7 July 1989 To: 21 July 1989

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
maize oil
Details on oral exposure:
VEHICLE
Concentration in vehicle: 20 g/100 mL maize oil

DOSE VOLUME APPLIED: 10 mL/kg bodyweight
Doses:
2000 mg/kg bodyweight
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The rats were observed frequently for signs of intoxication during the first 4 post-treatment hours and later on, at least once daily, throughout an observation period of 14 days. Individual body weights were recorded on day 0, 3, 7 and 14.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: no mortality at only dose tested. No adverse clinical signs after 48 hours, no treatment-related necropsy findings
Mortality:
No mortality
Clinical signs:
At 1 and 4 hours after treatment all male and female rats showed severe signs of sluggishness and moderate to severe signs of piloerection. At 24 hours after treatment all female rats showed moderate signs of piloerection and soiled fur. These signs of intoxication were not observed after 48 hours and onwards.
Body weight:
No effect on bodyweight
Gross pathology:
No treatment-related gross alterations

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral LD50 for carbon black oil to male and female rats is greater than 2000 mg/kg bw
Executive summary:

The acute oral toxicity of carbon black oil (CAS 64742-90-1) was determined in a group of 5 male and 5 female rats dosed at 2000 mg/kg bw using maize oil as the vehicle. Animals were observed for 14 days and necropsied at termination.

There were no mortalities or abnormalities at necropsy. Clinical signs of toxicity included sluggishness, piloerection and soiled fur which were completely reversed by 48 hours after dosing.

 

The LD50 is > 2000 mg/kg and carbon black oil (CAS 64742-90-1) does not warrant classification under GHS/CLP.