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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

- Skin irritation / corrosion: Acute (4h) skin irritation / corrosion study (semiocclusive (shaved)), rabbit (New Zealand White) (OECD guideline 404, EU Method B.4, EPA OTS 798.4470, GLP): Not irritating to the skin;
- Eye irritation: Acute (72h) skin irritation / corrosion study, rabbit (New Zealand White) (OECD guideline 405, EU Method B.5, EPA OTS 798.4500, GLP): Not irritating to the eye

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

No skin and eye irritation studies are available with full range (C8-C16) GTL Kerosine. Reliable guideline studies, compliant with GLP, have been conducted with a limited range (C8-C12) GTL Kerosine. These were assigned as the key studies since the full study reports were available for review, and the test substance was derived from the Fischer-Tropsch process.

The key skin irritation study was conducted in accordance with OECD 404 and GLP (Huntingdon Life Sciences Ltd., 1997c). 4-hour semi-occlusive application of undiluted test material caused very slight erythema (Grade 1) in all six animals during the first 72 hours after patch removal, persisting in one animal until day 7. Very slight oedema (Grade 1) was apparent in one animal only, during the first 72 hours after patch removal. The observed effects were not sufficient to require classification for skin irritation according to EC criteria.

The key eye irritation study was conducted in accordance with OECD 405 and GLP (Huntingdon Life Sciences Ltd., 1997d). Instillation of undiluted test material into the rabbit eye produced slight conjunctival redness (Grade 1) in four out of six animals at one and 24 hours after instillation. Iritis (Grade 1) was also apparent in the treated eye of one animal at one hour after exposure. Ocular reactions were present in the remaining two animals. All eyes appeared normal by day 8. The test substance was found to be not irritating to eye. The observed effects were not sufficient to require classification for eye irritation according to EC criteria.

In addition, GLP compliant guideline studies are available for both skin and eye irritation with the substanceSarapar 147, which is a GTL-derived material with carbon range C13-17 (IIBAT, 2004a and 2004b). In the skin irritation study, none of the test animals exhibited any skin reactions at any of the time points observed. In the eye irritation study, no lesions were observed in any of the test animals at the time points observed.

No data on respiratory tract irritation are available. Anyhow, taking into account the results from the available and reliable studies on skin and eye irritation / corrosion, respiratory tract irritation is not likely and furthermore it is not a mandatory endpoint under REACH.

The following information is taken into account for any hazard / risk assessment:

The key studies are reliability 1 guideline studies with limited range (C8-C12) GTL Kerosine. The test substance was not irritating to rabbit skin or eyes according to EC criteria. Supporting studies are available for a GTL-derived product with carbon range C13-C17, which was also non-irritant to rabbit skin and eyes. Between the key and supporting studies, all carbon numbers present in full-range GTL Kerosine are covered.


Justification for selection of skin irritation / corrosion endpoint:
No skin irritation study is available with full range (C8-C16) GTL Kerosine. However, a reliable guideline study, compliant with GLP, has been conducted with a limited range (C8-C12) GTL Kerosine. It was assigned as the key study and therefore as most relevant study for this endpoints selection because the full study report was available for review, and the test substance was derived from the Fischer-Tropsch process.
Nevertheless, the allocation of the study has no influence on the effect level as in both studies (key and supporting study) the test substance was determined to be not irritating to the skin.

Justification for selection of eye irritation endpoint:
No eye irritation study is available with full range (C8-C16) GTL Kerosine. However, a reliable guideline study, compliant with GLP, has been conducted with a limited range (C8-C12) GTL Kerosine. It was assigned as the key study and therefore as most relevant study for this endpoints selection because the full study report was available for review, and the test substance was derived from the Fischer-Tropsch process.
Nevertheless, the allocation of the study has no influence on the effect level as in both studies (key and supporting study) the test substance was determined to be not irritating to the eye.

Justification for classification or non-classification

Based on the available in-vivo skin and eye irritation studies, GTL Kerosine does not require classification for irritation according to the criteria of Regulation 1272/2008/EC. Since GTL Kerosine contains low molecular weight aliphatic hydrocarbons, it is considered appropriate to apply the hazard statement EUH066 ‘Repeated exposure may cause skin dryness and cracking’.