Registration Dossier

Administrative data

Description of key information

Acute Oral Toxicity:

The acute oral LD50 for other gas oils is > 5000 mg/kg of bodyweight in male and female rats, based on no mortality and minimal signs of toxicity (OECD 401).

Acute Inhalation Toxicity:

The acute inhalation LC50 for other gas oils for both male and female rats is 4.6 mg/L (aerosol) (OECD 403). This is supported by a further study  in which a hydrodesulphurised middle distillate gave an LC50 of 7.64 mg/L (aerosol). In addition a read-across study with a straight run gas oil gave an LC50 of >2.53 mg/l

Acute Dermal Toxicity:

The acute dermal LD50 for other gas oils is > 2000mg/kg body weight for male and female rabbits, based on no mortality or evidence of adverse effects (OECD 402).

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw
Quality of whole database:
One of two studies carried out simultaneously on different samples of CAS 64742-80-9

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LC50
Value:
4 600 mg/m³
Quality of whole database:
One of two studies carried out simultaneously on different samples of 64741-44-2. Also similar results in a read across study with a straight run gas oil

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
One of two studies carried out simultaneously on different samples of CAS 64742-80-9

Additional information

Acute Oral Toxicity:

The key acute oral toxicity studies investigated the effects of hydrodesulfurised middle distillate (Klimisch scores = 2, API 1982a,b). Fasted Sprague Dawley rats (5 male/5 female) were administered a single oral dose of >5000 mg/kg body weight via gavage. After 14 days of observation, no mortality or abnormal changes in body weight were observed in any of the rats. At necropsy, two mildly enlarged cervical lymph nodes, a distended stomach, moderately dilated renal pelvis, and alopecia on the stomach area and red exudate and severe corneal ulcerations in the eyes were found. The acute oral LD50 was > 5000 mg/kg body weight.  A similar result was seen in a supporting study with another sample of the same material.

  

Acute Inhalation Toxicity

For acute inhalation toxicity, the key study investigated the effects of hydrodesulfurised middle distillate in male and female Sprague Dawley rats exposed (whole body) to aerosol concentrations in the range of 0 - 7.3 mg/L for 4 hours (Klimisch score = 2, API 1983a). There were no reported mortalities during the 4hr exposure period, deaths occurring during the 14 day post-exposure observation period. Macroscopic and microscopic findings were limited to the lungs, where moderate to severe pulmonary irritation was apparent. Based on these results the LC50 for both males and females is 4.6 mg/L (aerosol) for other gas oils.

 

Additional data exist on the acute inhalation of other gas oils (API, 1983). This information on a hydrodesulfurised middle distillate aerosol is presented in the dossier. It had an LC50 of 7.64 mg/L, which is higher than the limit for classification.

In a supporting read-across acute inhalation toxicity study (EMBSI, 1991), a sample of a straight run gas oil (CAS no. 64741-44-2) was administered to Sprague-Dawley rats (5/sex/dose) via inhalation (in air; nose only) at a concentration of 2.53 mg/L for a period of 4 hours. The four hour acute inhalation LC50 for the test material was determined to be greater than 2.53 mg/L.

 

Acute Dermal Toxicity

The key acute dermal toxicity studies investigated the effects of hydrodesulfurised middle distillate at a dose of 2000 mg/kg body weight for 24 hours on male and female rabbits (Klimisch scores = 1, API 1982a,b). Animals were observed for 14 days post-exposure. Neither study reported mortality in the study, and only slight skin irritation. A similar result was seen in a supporting study with another sample of the same material.

 Based on results, the LD50 for other gas oils is >2000 mg/kg body weight.

Justification for classification or non-classification

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Other Gas Oils are not classified for acute oral or dermal toxicity based on the LD50 values, which are greater than the criteria for classification defined in the EU CLP Regulation (EC No. 1272/2008). 

 

Other Gas Oils are classified as harmful by inhalation (H332) based on a conservative read-across study showing an LC50 of > 2.53 mg/L (mist - mixed aerosol and vapour) for male and female rats seen with straight-run gas oils, according to the EU CLP Regulation (EC No. 1272/2008).

 

Regulatory classification and labelling for aspiration toxicity relies on the measured or calculated kinematic viscosity of a substance at 40°C rather than results from toxicological studies with animals. Hydrocarbons with kinematic viscosities ≤20.5 mms/sec are classified for aspiration toxicity (H304) according to EU CLP criteria. As members of this category exist as low viscosity liquids that meet these criteria, substances in this category are classified for aspiration hazard. Other Gas Oils are classified as aspiration hazards (H304).