Kerosine (Fischer-Tropsch), full-range, C8-16-branched and linear

Endpoint summary

Description of key information

- Acute Toxicity Oral: Acute study oral (gavage), rat (Sprague-Dawley), female (OECD guideline 420, EU Method B.1, GLP), (LD50 (oral) >5000 mg/kg bw;
- Acute Toxicity Dermal: Acute study dermal (occlusive), rat (Sprague-Dawley) male/female(OECD guideline 402, EU Method B.3, EPA OTS 798.1100, GLP), LD50 (dermal) >2000 mg/kg/ bw

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:

This endpoint is covered by two GLP guideline studies, one on the registered substance itself (which has consequently a reliability 1) and the other performed on an analogue substance with represents a shorter chain length spectrum (C8-C12) as the registered substance 'Kerosines (Fischer-Tropsch), C8 -16 branched and linear'. However, since the analogue substance represent the part of the registered UVCB substance, which might be toxicologically more critical to to the shorter chain lenghts, both studies should be considered equally when assessing possible health hazards. Additionally, both studies revealed consistent results, i.e. a LD50 > 5000 mg/kg bw.
In conclusion, the database can be considered to be of very good quality.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

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:

The effect level was derived from five independent studies, where the key study was acceptable, well documented and compliant to GLP. There is no acute dermal toxicity data are available for the full range (C8-C16) GTL Kerosine, but the available studies in a sum cover the whole chain length distribution of the registered substance. The quality of the supporting studies is not assignable with th available information. Nevertheless all study results show a very good consistance of the results as all five studies revealed an LD50 > 2000 mg/kg bw.
So taking into account the number of availabe studies and the consistency of the results, the quality of the whole database can be considered to be very good.

Additional information

The results of experimental studies for the acute oral and dermal toxicitiy are summarised in the following two tables:

Table 1: Overview of experimental studies on acute toxicity after oral administration

Method	Results	Remarks	Reference
rat (Sprague-Dawley) female oral: gavage according to OECD Guideline 420 (Acute Oral Toxicity)	LD50: > 5000 mg/kg bw (female) based on: test mat. (No test substance-related deaths.)	1 (reliable without restriction) key study experimental result Test material (EC name): Kerosine (Fischer-Tropsch), full range, C8-16 - branched and linear	Sanders, 2006
rat (Sprague-Dawley) male/female oral: gavage according to OECD Guideline 401 (Acute Oral Toxicity)	LD50: > 5000 mg/kg bw (male/female) based on: test mat. (No test substance-related deaths.)	1 (reliable without restriction) supporting study experimental result Test material (EC name): Kerosine (Fischer-Tropsch), limited range, C8-12 - branched and linear	Huntingdon Life Sciences, 1997a

Table 2: Overview of experimental studies on acute toxicity after dermal administration

Method	Results	Remarks	Reference
rat (Sprague-Dawley) male/female Coverage: occlusive according to OECD Guideline 402 (Acute Dermal Toxicity)	LD50: > 2000 mg/kg bw (male/female) based on: test mat. (No deaths occurred.)	1 (reliable without restriction) key study experimental result Test material (EC name):Kerosine (Fischer-Tropsch), limited range, C8-C12 - branched and linear	HuntingdonLife Sciences, 1997b
rat according to OECD Guideline 402 (Acute Dermal Toxicity)	LD50: > 2000 mg/kg bw	4 (reliability not assignable) supporting study read-across from supporting substance (structural analogue or surrogate) Test material : Alkanes C14-C17	IUCLID 2000 dataset for CAS 90622-53-0 citing:HRC Report 84411D/PEQ 2/AC; Sponsor: PETRESA
rabbit no guideline stated	LD50: > 3980 – 5730 mg/kg bw	4 (reliability not assignable) supporting study read-across from supporting substance (structural analogue or surrogate) Test material : n-C10 and n-C12 alkanes	IUCLID 2000 dataset for CAS 90622-53-0 citing:Scientific Associates, Inc., Vista Chemical Company, 1982b
rabbit no guideline stated	LD50: > 2000 mg/kg bw	4 (reliability not assignable) supporting study read-across from supporting substance (structural analogue or surrogate) Test material : n-C12 and n-C14 alkanes	IUCLID 2000 dataset for CAS 90622-53-0 citing:Scientific Associates, Inc., Vista Chemical Company, 1982c
rabbit no guideline stated	LD50: > 2000 mg/kg bw	4 (reliability not assignable) supporting study read-across from supporting substance (structural analogue or surrogate) Test material : n-C14 and n-C16 alkanes	IUCLID 2000 dataset for CAS 90622-53-0 citing:Scientific Associates, Inc., Vista Chemical Company, 1982c

The key acute oral toxicity of GTL Kerosine (full range, C8 -C16) reported an LD₅₀value of >5000 mg/kg bw for the test substance in female rats (Sanders, 2006). There were no deaths, no systemic toxicity or treatment related abnormalities at necropsy reported for the test substance. The study was conducted in accordance with OECD 420 (Fixed Dose Method) and GLP.

In a supporting study (Huntingdon Life Sciences, 1997a), conducted according to the now-deleted OECD 401 and GLP, the LD₅₀for GTL Kerosine (limited range, C8-C12) was also >5000 mg/kg bw.

No acute dermal toxicity data are available for the full range (C8-C16) GTL Kerosine. A study on the acute dermal toxicity of GTL Kerosine with a limited range, (C8-C12) reported an LD₅₀value of >2000 mg/kg bw for the test substance in rats (Huntingdon Life Sciences, 1997b). There were no deaths, no systemic toxicity or treatment related abnormalities at necropsy reported for the test substance.

In addition, relevant data are available for a number of related substances following administration by the dermal route, covering the higher carbon numbers in the range C12-C16. In all cases, the reported LD₅₀values are >2000 mg/kg bw.

Taking all available acute dermal toxicity data for relevant carbon numbers into consideration it can be concluded that the LD₅₀is >2000 mg/kg bw.

Justification for selection of acute toxicity – oral endpoint
There are two studies on acute oral toxicity available, and a LD50 > 5000 mg/kg bw was determined in both studies. However, the endpoint "Acute toxicity: oral, 2041/0046" (Sanders, 2006) was selected as both key study and most relevant study for this endpoint because the testing substance represents the registered substance more precisely: Here, the test item is identical with the registered substance 'Kerosines (Fischer-Tropsch), C8 -16 branched and linear', whereas the study outlined in endpoint "RA - Acute toxicity: oral, 97.1212" (Huntingdon Life Sciences, 1997a) was performed on "Kerosine (Fischer-Tropsch), limited range, C8-12 - branched and linear", which only represents a limited chain length range of the registered substance. Nevertheless, the allocation of the study has no influence on the effect level as in both studies a LC50 of >5000 mg/kg bw was determined.

Justification for selection of acute toxicity – inhalation endpoint
In accordance with Column 2 of REACH Annex VIII, the acute toxicity study via the inhalation route (required in Section 8.5.2 of REACH Annex VIII) does not need to be conducted as reliable data are available for the oral and dermal routes.

Justification for selection of acute toxicity – dermal endpoint
No acute dermal toxicity data are available for the full range (C8-C16) GTL Kerosine.
The acute toxicity via dermal route was assessed in an approach using data on the toxicologically more relevant derivatives with shorter chain lengths, supported by four studies on analogues with different chain lenth distributions, which cover in a sum the full range of the chain lengths of (C8-C16) GTL Kerosine. The study "RA Acute toxicity: dermal, 97-1213" was selected because the full study report was available for review and the test substance was derived from the Fischer-Tropsch process. An LD50 value of >2000 mg/kg bw for the test substance in rats (Huntingdon Life Sciences, 1997b) was reported. There were no deaths, no systemic toxicity or treatment related abnormalities at necropsy reported for the test substance.
This result is consistent with the results derived from the other four studies on analogue substances with different chain lengths; in all cases, the reported LD50 values are >2000 mg/kg bw. Hence, the endpoint selection has no influence of the effect level used for risk assessment (LD50 >2000 mg/kg).

Justification for classification or non-classification

On the basis of the available oral and dermal data, GTL Kerosine does not require classification for lethal effects following a single exposure according to Regulation 1272/2008/EC.

Since the substance is composed of aliphatic hydrocarbons and has low viscosity (measured kinematic viscosity 0.921 cSt at 40°C), it may present an aspiration hazard in humans following oral exposure. It is therefore appropriate to classify the substance as Aspiration Toxicity Category 1 according to Regulation 1272/2008/EC.

 

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