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Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated 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: Read across from experimental result for a related substance (with limited range, C8-C12). Study conducted in compliance with GLP; acceptable, well-documented study report which meets basic scientific principles.
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: Not reported
- Weight at study initiation: Not reported
- Housing: Stainless-steel cages with grid floors and tops
- Diet (e.g. ad libitum): commercially available pelleted guinea pig diet (Guinea pig F.D.1), was fed without restriction
- Water (e.g. ad libitum): free access
- Acclimation period: at least 6 days, up to max. 16 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 °C (range 15 to 23 °C)
- Humidity (%): 55% R.H. (range 50 to 70% R.H.)
- Air changes (per hr): at least 10 complete air changes per hour (without re-circulation)
- Photoperiod (hrs dark / hrs light): 12 hours artifical light per day, no natural light

Route:
intradermal and epicutaneous
Vehicle:
paraffin oil
Concentration / amount:
Concentrations of test material and vehicle used at each stage of induction:
- First induction: 50% w/v in paraffin oil
50% w/v in FCA
- Topical induction: undiluted as supplied

Concentrations of test material and vehicle used at each stage of challenge:
- Topical challenge: 50% v/v in paraffin oil
10% v/v in paraffin oil
Route:
epicutaneous, occlusive
Vehicle:
paraffin oil
Concentration / amount:
Concentrations of test material and vehicle used at each stage of induction:
- First induction: 50% w/v in paraffin oil
50% w/v in FCA
- Topical induction: undiluted as supplied

Concentrations of test material and vehicle used at each stage of challenge:
- Topical challenge: 50% v/v in paraffin oil
10% v/v in paraffin oil
No. of animals per dose:
TEST GROUP: 20 (10m/10f)
CONTROL GROUP: 20 (10m/10f)
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: intradermal injection day 0, topical application on day 7

- Test groups: 20 animals (ten male and 10 female animals)
- Control group: 20 animals
- Site: area of skin 8 cm x 6 cm, overlying the scapulae
- Frequency of applications: one-time

- Duration:
after topical application the test side was covered with occlusive dressing for 48 hours
- Concentrations:
intradermal injection: 50% v/v 'Kerosine (Fischer-Tropsch), limited range, C8-12, branched and linear' in paraffin oil and 50% v/v 'Kerosine (Fischer-Tropsch), limited range, C8-12, branched and linear' in adjuvant;
topical application: 'Kerosine (Fischer-Tropsch), limited range, C8-12, branched and linear'.

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: on day 22 of test
- Exposure period: 24 hours
- Test groups: 20 animals (ten male and 10 female animals)
- Control group: 20 animals
- Site: area of skin 8 cm x 6 cm, overlying the scapulae
- Concentrations: 10 and 50% v/v 'Kerosine (Fischer-Tropsch), limited range, C8-12, branched and linear' in paraffin oil;
- Evaluation (hr after challenge): 24 and 48 hours


Challenge controls:
Challenge application of paraffin oil alone
Positive control substance(s):
yes
Remarks:
Hexylcinnamic aldehyde (HCA)
Positive control results:
Challenge application of paraffin oil alone caused a positive response in two control animals.
Challenge application of 50% v/v HCH in propylene glycol to the positive control study gave rise to a positive response in nine positive control and one control animals.
A positive response was evident in nine positive control and two control animals following challenge application of 30% v/v HCH in propylene glycol.
No dermal response was evident following challenge application of propylene glycol alone.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50% (v/v)
No. with + reactions:
6
Total no. in group:
20
Clinical observations:
eschar formation and oedema
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50% (v/v). No with. + reactions: 6.0. Total no. in groups: 20.0. Clinical observations: eschar formation and oedema.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50% (v/v)
No. with + reactions:
17
Total no. in group:
20
Clinical observations:
exfoliation
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50% (v/v) . No with. + reactions: 17.0. Total no. in groups: 20.0. Clinical observations: exfoliation.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10% (v/v)
No. with + reactions:
2
Total no. in group:
20
Clinical observations:
eschar formation and oedema
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10% (v/v). No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: eschar formation and oedema.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10% (v/v)
No. with + reactions:
7
Total no. in group:
20
Clinical observations:
slight erythema
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10% (v/v). No with. + reactions: 7.0. Total no. in groups: 20.0. Clinical observations: slight erythema.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10% (v/v)
No. with + reactions:
12
Total no. in group:
20
Clinical observations:
exfoliation
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10% (v/v). No with. + reactions: 12.0. Total no. in groups: 20.0. Clinical observations: exfoliation.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
paraffin only
No. with + reactions:
13
Total no. in group:
20
Clinical observations:
exfoliation
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: paraffin only. No with. + reactions: 13.0. Total no. in groups: 20.0. Clinical observations: exfoliation.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50% (v/v)
No. with + reactions:
5
Total no. in group:
20
Clinical observations:
eschar formation and oedema
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50% (v/v). No with. + reactions: 5.0. Total no. in groups: 20.0. Clinical observations: eschar formation and oedema.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50% (v/v)
No. with + reactions:
19
Total no. in group:
20
Clinical observations:
exfoliation
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50% (v/v). No with. + reactions: 19.0. Total no. in groups: 20.0. Clinical observations: exfoliation.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
10% (v/v)
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
eschar formation and odema
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10% (v/v). No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: eschar formation and odema.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
10 % (v/v)
No. with + reactions:
2
Total no. in group:
20
Clinical observations:
slight erythema
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10 % (v/v). No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: slight erythema.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
10% (v/v)
No. with + reactions:
16
Total no. in group:
20
Clinical observations:
exfoliation
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10% (v/v). No with. + reactions: 16.0. Total no. in groups: 20.0. Clinical observations: exfoliation.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
paraffin only
No. with + reactions:
14
Total no. in group:
20
Clinical observations:
exfoliation
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: paraffin only. No with. + reactions: 14.0. Total no. in groups: 20.0. Clinical observations: exfoliation.

Signs of irritation during induction: 50% v/v - moderate erythema and oedema; no dermal response was evident following a similar administration of 50% v/v of test material in paraffin oil.

Occluded topical induction of test material as supplied gave rise to slight erythema, eschar formation, exfoliation, yellow staining, loss of flexibility and oedema.

Evidence of sensitization at each challenge: Challenge application of 50% v/v test material in paraffin oil gave rise to eschar formation or oedema in six test and five control animals. Exfoliation was evident in seventeen test and nineteen control animals. Challenge application of 10% v/v test material in paraffin oil caused eschar formation in two test and no control animals; a further seven test and two control animals showed slight erythema. Exfoliation was evident in twelve test and sixteen control animals. Challenge application of paraffin oil alone gave rise to slight erythema in two control animals. Exfoliation was evident in thirteen test and fourteen control animals. On this basis it is considered that a significant dermal response was observed in no test animal following challenge with 50% v/v test material in paraffin oil and in two test animals following challenge application of 10% v/v test material in paraffin oil.

Other observations: Abrasions were evident in the majority of test animals after second (topical) induction; the control animals remained in overt good health. One test animal was found dead on Day 2; necropsy revealed incomplete collapse of the lungs. All surviving animals achieved anticipated overall bodyweight gains.

Primary irritation screen

Phase 1 - Intradermal administration 

Animal number and sex

Concentration of Test material

Dermal responses at

24 hours

time after injection 48 hours

7 days

311M

50% v/v in vehicle+

1

1

0

30% v/v in vehicle

1

I

0

10% v/v in vehicle

1

0

0

50% v/v inFCA

2d

2d

0

30% v/v in FCA

2

2

0

10% v/v in FCA

2

1

0

317F

50% v/v in vehicle+

1

0

0

30%o v/v in vehicle

1

0

0

10% v/v in vehicle

1

0

0

50% v/v in FCA

2

1

0

30% v/v in FCA

2

1

0

10% v/v in FCA

1

0

0

312M

5% v/v in vehicle

0

0

0

3% v/v in vehicle

0

0

0

1%) v/v in vehicle

1p

0p

0

5% v/v in FCA

1

0

0

3% v/v in FCA

1

0

0

1% v/v in FCA

1

0

0

318F

5% v/v in vehicle

0

0

0

3% v/v in vehicle

0

0

0

1 % v/v in vehicle

1

0

0

5% v/v in FCA

1

1

0

3% v/v in FCA

0

0

0

1% v/v in FCA

0

0

0

0      No response

1      Slight erythema

2      Moderate erythema

d      Test site discoloured

p      pallor

FCA Freunds Complete Adjuvant

+      Maximum practicable concentration (Section 3.5)

Primary irritation screen

Phase 2 - Topical induction administration 

Animal number and sex

Concentration of Test material in vehicle

Dermal responses at time after removal of dressings

24 hours

48 hours

7 days

313M

100%+

0

0

0

50% v/v

0

0

0

30% v/v

0

0

0

10% v/v

0

0

0

319F

100%+

0

0f

0

50% v/v

0

0

0

30% v/v

0

0

0

10% v/v

0

0

0

0      No response

f       Exfoliation

+      Maximum practicable concentration (Section 3.5)

 

Primary irritation screen

Phase 3 - Topical challenge administration 

Animal number and sex

Concentration of Test material in vehicle

Dermal responses at time after removal of dressings

24 hours

48 hours

314M

100%+

0

0f

50% v/v

0

0

30% v/v

0f

0f

10% v/v

0

0

315M

100%+

0f

0f

50% v/v

0

0

30% v/v

0

0

10% v/v

0

0

320F

100%+

3'e

3'e

50% v/v

0

0

30% v/v

1

0f

10% v/v

0

0

0      No response

1      Slight erythema

3'e    Eschar formation

f       Exfoliation

+      Maximum practicable concentration (Section 3.5)

 

First phase of induction - dermal responses after intradermal injection 

Control Group 

Response

Number of animals showing response+

A

B

C

Male

Female

Male

Female

Male

Female

No response

 

 

10

10

2

 

Slight erythema

1

 

 

 

1

1

Moderate erythema

9

10

 

 

7

9

Pallor

 

 

 

 

1

 

+   Ten animals in each sex-group

A:  FCA

B:  Vehicle

C:  Vehicle in FCA

Test Group 

Response

Number of animals showing response+

A

B

C

Male

Female

Male

Female

Male

Female

No response

 

 

10

9

 

 

Moderate erythema

10

9

 

 

10

9

Oedema

 

 

 

 

9

9

+      Ten animals in each sex-group - one female animal was found dead on Day 2.

A:     FCA

B:     Test material in vehicle

C:     Test material in FCA

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
It was concluded that, under the conditions of this study, repeated administration of 'Kerosine (Fischer-Tropsch), limited range, C8-12, branched and linear', an analogue to 'Distillates (Fischer-tropsch), C8-26 - branched and linear' had a weak potential to cause delayed contact hypersensitivity in guinea pigs. The incident of significant response was below the EEC trigger threshold for classification as a dermal sensitizer (acc. to 67/548/EEC and EC No. 1272/2008).
Executive summary:

The potential of 'Kerosine (Fischer-Tropsch), limited range, C8-12, branched and linear' to cause delayed contact hypersensitivity in the guinea-pig was assessed in a Magnusson-Kligman Maximization Test according to OECD guideline 406. 

Intradermal injection of 50% v/v 'Kerosine (Fischer-Tropsch), limited range, C8-12, branched and linear' in adjuvant gave rise to slight erythema and oedema; no dermal response was evident. Following a similar administration of 50% v/v 'Kerosine (Fischer-Tropsch), limited range, C8-12, branched and linear' in paraffin oil.

Occluded topical (induction) application of 'Kerosine (Fischer-Tropsch), limited range, C8-12, branched and linear' gave rise to slight erythema, eschar formation, exfoliation, yellow staining, loss of flexibility and oedema.

Challenge application of 50% v/v 'Kerosine (Fischer-Tropsch), limited range, C8-12, branched and linear' gave rise to a positive response (slight erythema or a more marked reaction) in seventeen test and eleven control animals.

Challenge application of 10% v/v 'Kerosine (Fischer-Tropsch), limited range, C8-12, branched and linear' in paraffin oil caused a positive response in nine test and two control animals.

It was concluded that, under the conditions of this study, repeated administration of 'Kerosine (Fischer-Tropsch), limited range, C8-12, branched and linear', an analogue to 'Distillates (Fischer-tropsch), C8-26 - branched and linear' had a weak potential to cause delayed contact hypersensitivity in guinea pigs. The incident of significant response was below the EEC trigger threshold for classification as a dermal sensitizer (according to 67/548/EEC and EC No. 1272/2008).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

No sensitisation studies are available for GTL Gasoil itself. However, data are available for the related substances limited range GTL Kerosine (C8-C12), GTL Paraffin Waxes Light (C15-C27) and GTL Paraffin Waxes (C15-C50), covering the entire carbon-range of GTL Gasoil. In addition, studies are available for a number of other substances in the relevant carbon-range. These are summarised in the following table:

Table: Overview of experimental studies on skin sensitisation

Method

Results

Remarks

Reference

Guinea pig (Dunkin-Hartley) male/female

Guinea pig maximisation test

Induction: intradermal and epicutaneous

Challenge: epicutaneous, semiocclusive

OECD Guideline 406 (Skin Sensitisation)

Not sensitising

No. with positive reactions:

1st reading: 9 out of 20 (negative control); 24 h after chall.; dose: 50%

2nd reading: 7 out of 20 (negative control); 48 h after chall.; dose: 50%

1st reading: 13 out of 19 (test group); 24 h after chall.; dose: 50%

2nd reading: 14 out of 19 (test group); 48 h after chall.; dose: 50%

1st reading: 0 out of 20 (negative control); 24 h after chall.; dose: 10%

2nd reading: 2 out of 20 (negative control); 48 h after chall.; dose: 10%

1st reading: 5 out of 20 (test group); 24 h after chall.; dose: 10%

2nd reading: 7 out of 20 (test group); 48 h after chall.; dose: 10%

1 (reliable without restriction)

key study

read-across from supporting substance

Test material (EC name): Kerosine (Fischer-Tropsch), limited range, C8-12 - branched and linear

Huntingdon Life Sciences, 1997e

LLNA

Sensitising

3 (not reliable)

disregarded study

read-across from supporting substance

Test material (EC name): Paraffin Waxes (Fischer- Tropsch), light, C15-27, branched and linear

SafePharm, 2006c

Guinea pig (Dunkin-Hartley) male/female

Guinea pig maximisation test

Induction: intradermal and epicutaneous

Challenge: epicutaneous, semiocclusive

OECD Guideline 406 (Skin Sensitisation)

Not sensitising

No. with positive reactions:

1st reading: 0 out of 5 (negative control); 24 h after chall.; dose: 50%

2nd reading: 0 out of 5 (negative control); 48 h after chall.; dose: 50%

1st reading: 0 out of 11 (test group); 24 h after chall.; dose: 50%

2nd reading: 0 out of 11 (test group); 48 h after chall.; dose: 50%

1st reading: 1 out of 5 (negative control); 24 h after chall.; dose: 100%

2nd reading: 0 out of 5 (negative control); 48 h after chall.; dose: 100%

1st reading: 3 out of 11 (test group); 24 h after chall.; dose: 100%

2nd reading: 0 out of 11 (test group); 48 h after chall.; dose: 100%

1 (reliable without restriction)

key study

read-across from supporting substance

Test material (EC name): Paraffin Waxes (Fischer- Tropsch), light, C15-27, branched and linear

Phycher Bio Developpement, 2007a

Guinea pig (Dunkin-Hartley) male/female

Guinea pig maximisation test

Induction: intradermal and epicutaneous

Challenge: epicutaneous, semiocclusive

OECD Guideline 406 (Skin Sensitisation)

Not sensitising

No. with positive reactions:

1st reading: 0 out of 5 (negative control); 24 h after chall.; dose: 50%

2nd reading: 0 out of 5 (negative control); 48 h after chall.; dose: 50%

1st reading: 0 out of 11 (test group); 24 h after chall.; dose: 50%

2nd reading: 0 out of 11 (test group); 48 h after chall.; dose: 50%

1st reading: 0 out of 5 (negative control); 24 h after chall.; dose: 100%

2nd reading: 0 out of 5 (negative control); 48 h after chall.; dose: 100%

1st reading: 0 out of 11 (test group); 24 h after chall.; dose: 100%

2nd reading: 0 out of 11 (test group); 48 h after chall.; dose: 100%

1 (reliable without restriction)

supporting study

read-across from supporting substance

Test material (EC name): Paraffin waxes (Fischer-Tropsch), full range C15-C50, branched and linear

Phycher Bio Developpement, 2007b

Guinea pig

Buehler test

no guideline stated

Not sensitising

1 (reliable without restriction)

supporting study

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

Test material (Trade name): Alkane 2 (C24

Hill Top Biolabs, 1995a

Guinea pig

Buehler test

no guideline stated

Not sensitising

1 (reliable without restriction)

supporting study

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

Test material (Trade name): Alkane 2 (C24

Hill Top Biolabs, 1995b

Guinea pig (Dunkin-Hartley) male/female

Guinea pig maximisation test

Induction: intradermal and epicutaneous

Challenge: epicutaneous, semiocclusive

OECD Guideline 406 (Skin Sensitisation)

Not sensitising

1 (reliable without restriction)

supporting study

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

Test material (Trade name): Alkane 2 (C24

SafePharm, 1995e

 

In a guinea pig maximisation test, conducted in accordance with OECD 406 and GLP, limited range GTL Kerosine (C8-C12) was tested at challenge concentrations of 50% v/v and 10% v/v in paraffin oil (Huntingdon Life Sciences, 1997e). Intradermal induction was performed at a concentration of 50% v/v, and topical induction used undiluted test substance.

Challenge application of 50% v/v gave rise to eschar formation or oedema in six test and five control animals, moderate erythema in one test animal and slight erythema in test and six control animals. Exfoliation was evident in seventeen test and nineteen control animals.

Challenge application of 10% v/v caused eschar formation in two test and no control animals; a further seven test and two control animals showed slight erythema. Exfoliation was evident in twelve test and sixteen control animals.

Challenge application of paraffin oil alone gave rise to slight erythema in two control animals. Exfoliation was evident in 13 test and 14 control animals.

Abrasions were evident in the majority of test animals after the second (topical) induction; the control animals remained in overt good health. One test group animal was found dead on Day 2; necropsy revealed incomplete collapse of the lungs. There were no clinical observations and no effects on overall bodyweight gains.

A significant dermal response (a reaction more marked than the most severe evident amongst the control animals) was observed in no test animal following challenge with 50% v/v GTL Kerosine in paraffin oil, and in 2/20 test animals following challenge application of 10% v/v GTL Kerosine in paraffin oil.

Under the conditions of the test, limited range GTL Kerosine was therefore not sensitising.

In a guinea pig maximisation test conducted according to OECD 406 and GLP, Paraffin Waxes (Fischer-Tropsch), light, C15-27, branched and linear (GTL Paraffin Waxes, C15-27) was tested at challenge concentrations of 100% and 50% in liquid paraffin. At the 100% challenge concentration, slight erythema was observed in 3/11 test group animals and 1/5 control group animals at the 24-hour observation. All skin reaction had fully resolved at the 48-hour observation. No skin reactions were observed in any test or control group animals at the 50% challenge concentration.

Under the conditions of the test, GTL Paraffin Waxes (C15-27) was therefore not sensitising.These studies were selected as key since the full study reports were available for review, the test substances were derived from the Fischer-Tropsch process, and the carbon ranges covered are most relevant for GTL Gasoil (C8-C26).

Studies using both the guinea pig maximisation method and Buehler method are available for the related substances GTL Paraffin Waxes (C15-C50) and Alkane 2 (C24). The results of these support the conclusions of the key studies.

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

No sensitisation studies are available for GTL Gasoil itself. However, reliable studies are available for a number of related substances covering the relevant range of carbon numbers, all of which indicate that the constituents present in GTL Gasoil are not sensitising.


Migrated from Short description of key information:
Not sensitising: based on results of three reliable OECD 406 studies for related substances, covering the carbon numbers in the range C12-C50.

Justification for selection of skin sensitisation endpoint:
No sensitisation data are available for the substance defined in section 1. For the endpoint conclusion a reliable study of a related substance with a limited range, (C8-C12) was selected. Further studies on supporting substances, covering the higher carbon numbers in the range C15-C50, confirm the result.

Respiratory sensitisation

Endpoint conclusion
Additional information:
Migrated from Short description of key information:
No data available for non-human and human information.

Justification for classification or non-classification

Based on the available in vivo skin sensitisation data for related substances covering the relevant carbon range, 'Distillates (Fischer-Tropsch), C8-26 - branched and linear' does not require classification as a skin sensitiser according to the criteria of Regulation 1272/2008/EC.