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Administrative data

Description of key information

Available data for 4 specific streams within this category [Carbon Black Oil (CAS 64742-90-1), E000014200 (CAS 68475-80-9), Rohnaphthalin-Gemisch (CAS 85117-10-8), Quenchoel (CAS 98072-36-7)], further information included in the Category Summary for Fuel Oils Category (ACC, 2005), and on specific components (benzene, toluene, ethylbenzene, styrene, naphthalene and anthracene) that are present in some streams indicate that acute toxicity is expected to be low. Naphthalene has been shown to be acutely toxic (producing haemolytic anaemia) in humans following oral exposure and ethylbenzene and styrene are hazardous following acute inhalation exposure. Therefore, classification will be required for streams containing a high proportion of naphthalene (≥25%) and styrene (>12.5%) but the highest concentration of ethylbenzene (10%) is too low to trigger classification. Following acute inhalation exposures to toluene in humans a number of subjective sensations such as headache, dizziness, feeling of intoxication, irritation and sleepiness and decreases in acute neurobehavioural performance are seen. The NOAEC for acute neurobehavioural effects in humans is 50 ppm (188 mg/m3) and classification (H336) will be required for streams containing ≥20% toluene.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
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
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
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
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 Dir 67448/EEC or GHS/CLP.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
Adequate information is available on representative members of this category, and on the component substances present, to characterise short-term hazards after ingestion.

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP, guideline study, available as unpublished report but otherwise acceptable for assessment.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GmbH, D-7950 Biberach
- Age at study initiation: approximately 8 weeks
- Weight at study initiation: mean: 238 g (males), 165 g (females)
- Housing: 3 per cage in type Becker D III cages
- Diet: Kliba rat/mouse A343 diet ad libitum except during exposure
- Water: approximately 250 mL/cage/day except during exposure
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20-24°C in animal room
- Humidity: 30-70%
- Air changes (per hr): not reported
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: 13 June to 28 June 1983
Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
other: air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Whole-body inhalation system: glass-steel construction
- Exposure chamber volume: 200 L
- Method of holding animals in test chamber: The animals were kept singly in cages
- Temperature in chamber: 20±1°C in exposure chamber
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
7 h
Remarks on duration:
In excess of guideline required duration
Concentrations:
1.6 mg/L
No. of animals per sex per dose:
6
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 1.6 mg/L air
Exp. duration:
7 h
Remarks on result:
other: no mortalities and no adverse clinical signs at only concentration tested
Mortality:
None
Clinical signs:
other: No findings during or after exposure
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute LC50 of Rohnaphthalin-Gemisch following a 7 hour exposure was > 1.6 mg/L in male and female rats.
Executive summary:

The acute inhalation toxicity of Rohnaphthalin-Gemisch (CAS 85117-10-8) was assessed in a group of 3 male and 3 female rats exposed for 7 hours to vapour at a concentration of 1.6 mg/L. There was no evidence of toxicity and no deaths.

The acute LC50 is greater than 1.6 mg/L (the highest concentration tested). The exposure duration was longer than required by the guideline and in the absence of any evidence of toxicity at this concentration it is considered that classification of Rohnaphthalin-Gemisch (CAS 85117-10-8) is not

warranted under Dir 67/548/EEC or GHS/CLP.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LC50
Value:
1 860 mg/m³
Quality of whole database:
Adequate information is available on representative members of this category, and on the component substances present, to characterise short-term hazards after inhalation.

Acute toxicity: via dermal route

Link to relevant study records
Reference
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
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
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
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
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.
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 Dir 67/548/EEC or GHS/CLP
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
Adequate information is available on representative members of this category, and on the component substances present, to characterise short-term hazards after skin contact.

Additional information

Non-human information

Acute oral toxicity data on the streams Carbon Black Oil (CAS 64742-90-1), Rohnaphthalin-Gemisch (CAS 85117-10-8) and Quenchoel (CAS 98072-36-7) indicate oral LD50 values in rats of > 2000 mg/kg. E000014200 (CAS 68475-80-9) had an oral LD50 value of < 5000 mg/kg. Acute inhalation toxicity on the streams Rohnaphthalin-Gemisch (CAS 85117-10-8) and Quenchoel (CAS 98072-36-7) showed no acute inhalation toxicity at the highest achievable concentrations and acute dermal toxicity studies on the streams Carbon Black Oil (CAS 64742-90-1) and E000014200 (CAS 68475-80-9) gave acute dermal LD50 values in rats of > 2000 mg/kg. Data on the components benzene, toluene, ethylbenzene, naphthalene and anthracene indicate that no classification is warranted on the basis of acute lethality following exposure via oral, dermal or inhalation routes. Styrene is considered to be harmful following inhalation exposure and toluene produces unsteady gait and other indications of neurobehavioural activity at concentrations < 20 mg/L justifying Category 3 H336 under Reg (EC) 1272/2008.

Human information

There are no specific studies on the oral, inhalation or dermal toxicity in humans for streams in this category.

Data from human experiences that provide information on acute exposures of value to the risk assessment process are available for benzene, toluene and naphthalene:

Benzene (Classification: Category 1, H304): Human data on oral toxicity indicate that ingestion of 15 mL (176 mg/kg bw) benzene can cause death after collapse, bronchitis and pneumonia (EU, 2008a). Exposure for 5-10 minutes to benzene vapours of 65-61 mg/L is fatal and exposure to 25 mg/L for 30 minutes is dangerous to life, while a one-hour exposure to 1.6 mg/L causes only some symptoms of illness.

Toluene (Classification: Category 1, H304, Cat 3 H336): The acute effects of toluene inhalation exposure include headache, dizziness, feeling of intoxication, irritation and sleepiness and decreases in acute neurobehavioural performance at concentrations ≥ 75 ppm (EU, 2003a). A NOAEC of 50 ppm (188 mg/m3) can be determined for acute neurobehavioural effects in humans (Muttray et al, 2005).

Naphthalene (Classification: Cat 4 H302): The EU RAR (EU, 2003b) concluded “Naphthalene is of low toxicity in rats, with mice being more sensitive. It appears that rodents are not suitable animal models for the acutely toxic human health effects of naphthalene in relation to haemolytic anaemia. Thus, while the LD50 results from the rat suggest relatively low acute toxicity in this species, the available information in humans indicates significant toxicity. Very severe haemolytic anaemia occurred in one case report (of a 16 year old female) at an estimated single oral dose of approximately 6 g. It is possible that this represents a lethal dose given that a number of blood transfusions were required.”


Justification for selection of acute toxicity – oral endpoint
Acute oral toxicity data on four representative members of this category indicate they do not present a short term hazard, although classification may be appropriate in some instances based on the level of naphthalene (haemolytic anaemia after acute exposure) or benzene, toluene or ethylbenzene (aspiration hazard) present.

Justification for selection of acute toxicity – inhalation endpoint
Acute inhalation toxicity data on two representative members of this category indicate they do not present a short term hazard after exposure to a saturated atmosphere, although classification may be appropriate in some instances based on the level of styrene (harmful if inhaled) or toluene (may cause drowsiness or dizziness) present.

Justification for selection of acute toxicity – dermal endpoint
Acute dermal toxicity data on two representative members of this category, together with information on the component substance present, indicate they do not present a short term hazard.

Justification for classification or non-classification

There are sufficient data on component substances to indicate that Fuel Oils streams are of low acute toxicity by the dermal and inhalation routes and do not warrant classification for these end-points under Reg (EC) 1272/2008.

Naphthalene is acutely toxic in humans producing haemolytic anaemia. Consequently Fuel Oils streams that contain ≥25% naphthalene will justify the following classification: Category 4 H302 under Reg (EC) 1272/2008.

Styrene is classified as harmful following inhalation exposure. Fuel Oils streams that contain ≥12 5% styrene will justify the following classification: Category 4 H332 “Harmful if inhaled” under Reg (EC) 1272/2008.

The viscosity and surface tension of three possible components of Fuel Oils streams (benzene, toluene and ethylbenzene) are such that labelling is required. Fuel Oils streams that meet the physicochemical requirements for Reg (EC) 1272/2008 will require Asp tox Category 1, H304.

Data from experimental exposure of human volunteers with toluene show that dizziness and sleepiness are experienced at air levels < 20 mg/L. Therefore, Fuel Oils streams that contain ≥20 % toluene will justify classification Category 3 H336 under Reg (EC) 1272/2008.