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Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
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other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment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 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
occlusive dressing used
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 10 weeks
- Weight at study initiation: 276-303 g for males, 174-197 g for females
- Fasting period before study: no
- 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 5 weeks

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: 31 July 1989 To: 15 August 1989

Administration / exposure

Type of coverage:
occlusive
Vehicle:
maize oil
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsal and the ventral side and the flanks
- Type of wrap if used: a plastic film, which was secured by an elastic adhesive bandage (Tensoplast) around the trunk of the rats

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes with water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 mL/kg bw
- Concentration (if solution): 20% w/v dilution in maize oil
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
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. Individual body weights were recorded on days 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 or evidence of toxicity at only dose tested
Mortality:
No mortality
Clinical signs:
No skin reactions were observed immediately after removal of the dressing and after 3 and 7 days. There were no clinical signs of intoxication.
Body weight:
Loss of body weight during the first 3 days after treatment was observed in males and in females. Subsequently they gained body weight at a normal
rate.
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 dermal LD50 to rats for Carbon Black Oil is greater than 2000 mg/kg bw.
Executive summary:

The acute dermal toxicity of Carbon black oil (CAS 64742-90-1) was investigated in groups of 5 male and 5 female rats. A single 24 hour application of 2000 mg/kg (20% w/v in maize oil at 10 mL/kg bw) was applied under an occlusive dressing and animals observed for 14 days for signs of toxicity and local irritation. There were no mortalities or evidence of toxicity or irritation. The acute dermal LD50 to rats for Carbon Black Oil is greater than 2000 mg/kg bw and no classification is warranted under GHS/CLP