Petroleum kerosene fraction, co-processed with renewable hydrocarbons of plant and/or animal origin

Endpoint summary

Description of key information

Based on read-across studies with hydrodesulphurised kerosine, a chemically similar material, the following acute toxicity properties are predicted:

• Oral LD50  > 5000 mg/kg bw in male and female rats.

• Dermal LD50 > 2000 mg/kg/bw in male and female rabbits.

• Inhalation LC50 > 5.2 mg/L vapour in male and female rats.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study is classified as reliable without restrictions because it was carried out in a method equivalent/similar to OECD TG 401.

Justification for type of information:

Read across justification included in Section 13

Reason / purpose for cross-reference:

read-across: supporting information

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Route of administration:

oral: gavage

Vehicle:

other: Undiluted

Doses:

Single dose level of 5000 mg/kg

No. of animals per sex per dose:

Five

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

No deaths resulted. Main clinical signs were hypoactivity, excess salivation, diarrhoea, urine-stained abdomen and hair loss around the anal area. At necropsy, the only visible finding was kidney distension in one male animal.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 was greater than 5000 mg/kg.

Executive summary:

The acute oral toxicity of hydrodesulfurised kerosine was studied in 5 male and 5 female albino Sprague-Dawley rats. Animals weighing 188-330g received a single dose of 5000 mg/kg by oral gavage and were observed for clinical signs and mortality at hourly intervals during the first 6 hours after administration. Thereafter animals were observed twice daily for 14 days. At termination of the study, all animals were sacrificed and subjected to gross necropsy examination. Clinical signs observed throughout the study include hypoactivity, excess salivation, diarrhoea, urine stained abdomen and hair loss around the anal area. No mortality was observed. The LD50 for hydrodesulfurised kerosine was > 5000 mg/kg.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study is classified as reliable without restrictions because it was carried out in a method equivalent/similar to OECD TG 403.

Justification for type of information:

Read across justification included in Section 13

Reason / purpose for cross-reference:

read-across: supporting information

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

not specified

Vehicle:

air

Details on inhalation exposure:

Exposure comprised of aerosol/vapour mixture.

Duration of exposure:

4 h

Concentrations:

Single 4 hour whole-body exposure to 5.2 mg/L

No. of animals per sex per dose:

Five

Control animals:

no

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 5.2 mg/L air

Exp. duration:

4 h

There were no mortalities during the study. The principal pharmacotoxic sign was dyspnoea which was observed on the day of exposure and for some animals up to 6 days after exposure. There was no effect on body weight gains and no treatment-related abnormalities were observed during necropsy or during the histopathological examination of the lungs and tracheas of the exposed animals.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LC50 was greater than 5.2 mg/L, the only dose tested.

Executive summary:

In an acute inhalation toxicity study, 5 male and 5 female albino Sprague-Dawley rats were exposed to an aerosol/vapour atmosphere of hydrodesulfurised kerosine for 4 hours at a concentration of 5.2 mg/L. All animals were observed during and after the exposure on the day of exposure and daily during a 14-day post-exposure observation period. Animal body weights were recorded just prior to exposure, on days 7 and 14 post-exposure and at death. At termination of the study, all animals were sacrificed and subjected to complete necropsy. Lungs and trachea were evaluated histopathologically. Dyspnea was the principal sign observed on the day of exposure and during the post-exposure period, with matted fur being a result of the aerosol exposure. There were no deaths during the study and no apparent exposure-related effects on the bodyweights. No exposure related histopathological changes were observed. The LC50 was greater than 5.2 mg/L. The test material is not classified according to EU criteria based on no upper limit for the LC50.

This study received a Klimisch score of 1 and is classified as reliable without restrictions because it was carried out in a method equivalent/similar to OECD TG 403.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LC50

Value:

5 200 mg/m³ air

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: This study is classified as reliable with restrictions because it is an acceptable and well-documented study report.

Justification for type of information:

Read across justification included in Section 13

Reason / purpose for cross-reference:

read-across: supporting information

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

other: API procedure

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Type of coverage:

not specified

Vehicle:

other: Undiluted

Duration of exposure:

24 hours

Doses:

Single dose of 2000 mg/kg

No. of animals per sex per dose:

Four

Control animals:

not specified

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

No deaths resulted. At necropsy, irritated skin at the treatment site was noted in one animal, and pitted areas on the kidneys in two animals.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 was greater than 2000 mg/kg.

Executive summary:

A group of 4 male and 4 female New Zealand White rabbits was tested at a single dose of 2000 mg/kg. The skins of 2 male and 2 female animals were abraded prior to treatment. Animals were observed for 14 days following the 24-hour exposure period. No deaths resulted. At necropsy, irritated skin at the treatment site was noted in one animal, and pitted areas on the kidneys in two animals. The LD50 was greater than 2000 mg/kg

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Additional information

Data on related substances have been used to 'read-across' and predict the hazard properties. A 'read-across' justification document can be found in section 13.

Hydrodesulphurised kerosine, a chemically related material is of low acute toxicity, with an oral LD50 greater than 5000 mg/kg (rat), a dermal LD50 greater than 2000 mg/kg (rabbit), and an inhalation LC50 greater than 5.2 mg/L (rat). The most important effects in animals following very high oral doses were slight irritation of the stomach and the gastrointestinal tract. The only adverse effects observed in acute inhalation studies were decreased activity and breathing frequency at very high doses. Dermal application of kerosine did not lead to acute toxic systemic effects. Clinical effects observed were related to dermal irritation rather than to systemic toxicity. The acute toxicity of kerosine is not classified by EU CLP Regulation (EC No. 1272/2008).

 

Acute oral toxicity 

In key acute oral toxicity study Sprague Dawley rats were given a single oral dose of undiluted hydrodesulphurised kerosine at a dose of 5000 mg/kg bw and observed for 14 days. There were no treatment related mortalities. All of the study animals exhibited one or more of the following clinical signs: nasal discharge, ocular discharge, abnormal stools, lethargy, stained coat, and alopecia. All animals gained weight during study period. At necropsy, one of the ten animals exhibited visual lesions, the remaining nine showed signs of alopecia in the inguinal and/or perineal regions. The oral LD50 was determined to be greater than 5000 mg/kg in males and females.

 

Acute inhalation toxicity

In the key acute inhalation toxicity study, Sprague-Dawley rats, were exposed by whole body inhalation to hydrodesulphurised kerosine for 4 hours at a dose of 5.2 mg/L. All animals exhibited decreased activity during the exposure. There were no deaths during the study and no treatment-related clinical signs of toxicity. No macroscopic lesions were observed in any animal at post-mortem. The LC50 was greater than 5.2 mg/L.

This result was supported by a series of studies (Carpenter et al., 1976), in which rats were administered doses of deoderised kerosine via inhalation. The LC50s as measured based on mortality and systemic effects do not indicate classification of kerosine as an acute inhalation toxicant, including repeated exposure of rats (6 hours each day for 4 days). Another supporting study on deodorised kerosine showed a lack of systemic effects after a single 6 hour exposure to cats. 

 

Acute dermal toxicity

In the key acute dermal toxicity study, groups of young adult New Zealand White rabbits, five males and five females, were dermally exposed to undiluted hydrodesulphurised kerosine for 24 hours to 10% of their body surface area at a dose of 2000 mg/kg. Animals were then observed for 14 days. There were no mortalities and all animals gained weight during the study. All of the animals exhibited one or more of the following clinical signs during the observation period: dermal irritation (erythema, edema, eschar, fissuring and/or dried skin) and/or abnormal stools. Apart from skin irritation, there were no other abnormalities noted at necropsy. The dermal LD50 was determined to be greater than 2000 mg/kg in both males and females.

 

Justification for classification or non-classification

Based on evaluation of all the acute toxicity data discussed above, the material does not meet the criteria for classification as an acute oral, inhalation or dermal toxicant under the EU CLP Regulation (EC No. 1272/2008). However, based on human experience, exposure to high concentrations of kerosine vapour may cause drowsiness and/or dizzyness.