Petroleum, synthetic, hydrodesulfurized full-range coker

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Between 06 August 2012 and 13 September 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.

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:

female

Details on test animals and environmental conditions:

Housing
The animals were housed individually or in groups of 2 in polycarbonate containers, the flooring of which was covered with dust-free cuttings and the top fitted with a stainless steel lid with a feeding device and drinking device of 500 mL.
The temperature and relative humidity of the main test were controlled to remain within target ranges of 19 to 25°C and 30 to 70%, respectively.
The rate of air exchange was between ten and fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (07.00 to 19.00) and twelve hours darkness.

Food and drink
The drinking water (tap water from public distribution system) and food (SDS, FD1) were supplied freely. Microbiological and chemical analyses of the water were carried out once every six months by Eurofins IPL Atlantique (Bordeaux).

Preparation of animals
Fifteen albino guinea pigs of Dunkin-Hartley strain, supplied by CHARLES RIVER (F-69592 L’ARBRESLE) weighed between 252 g and 285 g at the beginning of the main test and were 4 weeks old.
Prior to the test, the animals were kept for a minimum acclimatization period of 5 days, under stabling and nutritional conditions identical to those of the test.
Before the experimentation process, they were identified individually by marking with picric acid and by means of a numbered ring on the edge of one ear.
The animals were carefully shorn before each test item application:
- On the inter-scapular zone for the induction phase,
- On the dorso-lumbar zone for the challenge phase.
At least 3 hours before the first reading (challenge phase) they were shorn a second time in this dorso-lumbar zone.
The animals were weighed at the beginning and at the end of the study.

Animal welfare
The study was performed in accordance with the French Animal Protection Law under licence number C 33-122-001.
The animals were provided with suitable environmental enrichment (tunnel).
The study was designed and was conducted to cause the minimum suffering or distress to the animals.

Route:

intradermal and epicutaneous

Vehicle:

olive oil

Concentration / amount:

Intradermal Induction: test item at 2% in olive oil
Topical Induction: test item at 100%
Challenge: test item at 2.5% and 1.25% in olive oil
Re-challenge: test item at 1% and 0.5% in olive oil

Route:

epicutaneous, occlusive

Vehicle:

olive oil

Concentration / amount:

Intradermal Induction: test item at 2% in olive oil
Topical Induction: test item at 100%
Challenge: test item at 2.5% and 1.25% in olive oil
Re-challenge: test item at 1% and 0.5% in olive oil

No. of animals per dose:

10 test
5 control

Details on study design:

Preliminary studies
Determination by intradermal injection of the Maximal Non Necrotizing Concentration (MNNC)
This test was conducted for the purpose of defining a MNNC of the test item which, on intradermal injection during the induction phase, does not risk causing too great a lesion (non-necrotizing concentration), should be well-tolerated systemically and should be the highest to cause mild-to-moderate skin irritation.
Two animals received a volume of 0.1 mL of the test item, on both sides of the spine, at 4 concentrations: 100%, diluted at 50%, 20% and 10% in olive oil in view to determine the MNNC.
A macroscopic evaluation of the cutaneous reactions was conducted 24 hours after the injections.
Due to necrosis observed at all concentrations, the same animals received a volume of 0.1 mL of the test item, on both sides of the spine, at 3 concentrations: diluted at 5%, 2% and 1% in olive oil in view to determine the MNNC.
A macroscopic evaluation of the cutaneous reactions was conducted 24 hours after injection.
 
Determination by topical application of the Pre-Maximal Non Irritant Concentration (Pre-MNIC)
This test, which allowed evaluating the irritancy potential of the test item, defined whether an application of sodium lauryl sulfate would be needed during topical induction phase.
The test item was applied on the dorso-lumbar zone of two guinea pigs shorn beforehand, with occlusive dressing for 24 hours, at 4 different concentrations: 100%, diluted at 50%, 20% and 10% in liquid paraffin.
A macroscopic evaluation of the cutaneous reactions was conducted 24 hours after removal of the dressing.

Determination by topical application of the Maximal Non Irritant Concentration (MNIC)
This test was carried out for the purpose of determining the MNIC of the test item without risk of an irritant effect during the challenge phase.
Three guinea pigs were treated according to the same treatment as animals from GROUP 1 (negative control) for the induction phase (i.e. olive oil and liquid paraffin).
During the challenge phase, the animals were treated with the test item placed onto the selected treatment sites and covered with an occlusive dressing for a period of 24 hours at 4 different concentrations: diluted at 20%, 10%, 5% and 2.5% in liquid paraffin.
A macroscopic evaluation of the cutaneous reactions was conducted 24 and 48 hours after removal of the occlusive dressing and rinse with liquid paraffin.

Main study
GROUP 1 (negative control) : 5 female guinea pigs identified n° C9203 to C9207
GROUP 2 (treated) : 10 female guinea pigs identified n° C9208 to C9217
Note: The results of the 3 last positive control groups (Reference substance: alpha Hexylcinnamaldehyde Tests 22-24) carried out in order to assess the sensitivity of the strain of guinea pig used at these laboratories to a known sensitiser are presented in Appendix 2.

Induction phase
1st Intradermal Induction:
Day 0
After shearing the scapular zone, three (3) pairs of intradermal injections (ID) of 0.1 mL were performed on the scapular zone in such a way as an injection on each pair is placed to either side of the spine as follows:
GROUP 1 (Negative control):
2 ID: Freund’s Complete Adjuvant diluted at 50 % in isotonic sodium chloride.
2 ID: olive oil
2 ID: a mixture with equal volumes v/v :
- Freund’s Complete Adjuvant at 50% and olive oil,
GROUP 2 (Treated):
2 ID: Freund’s Complete Adjuvant diluted by 50 % in isotonic sodium chloride,
2 ID: test item at 2% in olive oil,
2 ID: a test mixture in equal volumes v/v :
- Freund’s Complete Adjuvant at 50% and the test item at 4% in olive oil.

2nd Topical Induction:
Day 6
The scapular zone of all the animals in each group shorn beforehand, was brushed with a solution of sodium lauryl sulphate at 10% in thick vaseline, in order to create a local irritation.
Day 7
A topical application under occlusive dressing for 48 hours was performed on the injection sites of each animal.
GROUP 1 (Negative control): 0.5 mL of liquid paraffin.
GROUP 2 (treated): 0.5 mL of the test item at 100%.
Day 9
Occlusive dressing removal and rinse with liquid paraffin.

Rest phase
The animals of both groups were left for 10 days.

Challenge phase
Day 20
The experimental procedure of this phase was identical for both groups GROUP 1 (Negative control) and GROUP 2 (Treated) submitted to this experimentation: on the previously shorn dorso-lumbar zone, an application on either side of the spine, under occlusive dressing, was performed during 24 hours:
- 1 sample cup containing the test item at 2.5% (MNIC) and 1 sample cup containing the test item diluted at 1.25% (1/2 MNIC).
Day 21
Occlusive dressing removal and rinse with liquid paraffin.

Re-Challenge phase
Day 27
The experimental procedure of this phase was identical for both groups GROUP 1 (Negative control) and GROUP 2 (Treated) submitted to this experimentation: on the previously shorn dorso-lumbar zone, an application on either side of the spine, under occlusive dressing, was performed during 24 hours:
- 1 sample cup containing the test item at 1% and 1 sample cup containing the test item diluted at 0.5%
Day 28
Occlusive dressing removal.

Positive control substance(s):

yes

Remarks:

a-Hexylcinnamaldehyde

Positive control results:

See Appendix 2 (attachment 9)

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

2.5%

No. with + reactions:

4

Total no. in group:

10

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 2.5%. No with. + reactions: 4.0. Total no. in groups: 10.0.

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

2.5%

No. with + reactions:

2

Total no. in group:

10

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 2.5%. No with. + reactions: 2.0. Total no. in groups: 10.0.

Reading:

other:

Hours after challenge:

72

Group:

test chemical

Dose level:

2.5%

No. with + reactions:

0

Total no. in group:

10

Remarks on result:

other: Reading: other:. . Hours after challenge: 72.0. Group: test group. Dose level: 2.5%. No with. + reactions: 0.0. Total no. in groups: 10.0.

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

1.25%

No. with + reactions:

6

Total no. in group:

10

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1.25%. No with. + reactions: 6.0. Total no. in groups: 10.0.

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

1.25%

No. with + reactions:

2

Total no. in group:

10

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1.25%. No with. + reactions: 2.0. Total no. in groups: 10.0.

Reading:

other:

Hours after challenge:

72

Group:

test chemical

Dose level:

1.25%

No. with + reactions:

0

Total no. in group:

10

Remarks on result:

other: Reading: other:. . Hours after challenge: 72.0. Group: test group. Dose level: 1.25%. No with. + reactions: 0.0. Total no. in groups: 10.0.

Reading:

1st reading

Hours after challenge:

24

Group:

negative control

Dose level:

2.5%

No. with + reactions:

5

Total no. in group:

5

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 2.5%. No with. + reactions: 5.0. Total no. in groups: 5.0.

Reading:

2nd reading

Hours after challenge:

48

Group:

negative control

Dose level:

2.5%

No. with + reactions:

1

Total no. in group:

5

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 2.5%. No with. + reactions: 1.0. Total no. in groups: 5.0.

Reading:

other:

Hours after challenge:

72

Group:

negative control

Dose level:

2.5

No. with + reactions:

0

Total no. in group:

5

Remarks on result:

other: Reading: other:. . Hours after challenge: 72.0. Group: negative control. Dose level: 2.5. No with. + reactions: 0.0. Total no. in groups: 5.0.

Reading:

1st reading

Hours after challenge:

24

Group:

negative control

Dose level:

1.25%

No. with + reactions:

5

Total no. in group:

5

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 1.25%. No with. + reactions: 5.0. Total no. in groups: 5.0.

Reading:

2nd reading

Hours after challenge:

48

Group:

negative control

Dose level:

1.25

No. with + reactions:

1

Total no. in group:

5

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 1.25. No with. + reactions: 1.0. Total no. in groups: 5.0.

Reading:

other:

Hours after challenge:

72

Group:

negative control

Dose level:

1.25%

No. with + reactions:

0

Total no. in group:

5

Remarks on result:

other: Reading: other:. . Hours after challenge: 72.0. Group: negative control. Dose level: 1.25%. No with. + reactions: 0.0. Total no. in groups: 5.0.

Reading:

rechallenge

Hours after challenge:

24

Group:

test chemical

Dose level:

1%

No. with + reactions:

1

Total no. in group:

10

Remarks on result:

other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 1%. No with. + reactions: 1.0. Total no. in groups: 10.0.

Reading:

rechallenge

Hours after challenge:

48

Group:

test chemical

Dose level:

1%

No. with + reactions:

0

Total no. in group:

10

Remarks on result:

other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 10.0.

Reading:

rechallenge

Hours after challenge:

24

Group:

test chemical

Dose level:

0.5%

No. with + reactions:

1

Total no. in group:

10

Remarks on result:

other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5%. No with. + reactions: 1.0. Total no. in groups: 10.0.

Reading:

rechallenge

Hours after challenge:

48

Group:

test chemical

Dose level:

0.5%

No. with + reactions:

0

Total no. in group:

10

Remarks on result:

other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 0.5%. No with. + reactions: 0.0. Total no. in groups: 10.0.

Reading:

rechallenge

Hours after challenge:

24

Group:

negative control

Dose level:

1%

No. with + reactions:

0

Total no. in group:

5

Remarks on result:

other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 5.0.

Reading:

rechallenge

Hours after challenge:

48

Group:

negative control

Dose level:

1%

No. with + reactions:

0

Total no. in group:

5

Remarks on result:

other: Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 5.0.

Reading:

rechallenge

Hours after challenge:

24

Group:

negative control

Dose level:

0.5%

No. with + reactions:

0

Total no. in group:

5

Remarks on result:

other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 0.5%. No with. + reactions: 0.0. Total no. in groups: 5.0.

Reading:

rechallenge

Hours after challenge:

48

Group:

negative control

Dose level:

0.5%

No. with + reactions:

0

Total no. in group:

5

Remarks on result:

other: Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 0.5%. No with. + reactions: 0.0. Total no. in groups: 5.0.

Interpretation of results

The test item will be regarded as a sensitiser if30% or more of the test animals show a sensitisation response.

 In accordance with the E.E.C. Directives 93/21 (O.J.E.C.L110 A, May 4^th, 1993), 91/325 dated March 5^th, 1991 (O.J.E.C. L 180 dated July 8^th, 1991) and 67/548, the results obtained for items can be classified according to European regulations concerning the classification, packaging and labelling of dangerous substances:

The substances or preparations will be classified as sensitising and characterised by the symbol “Xi” and the danger label “Irritant” with the risk sentence R43 in accordance with the criteria below:

 R 43 : may cause sensitisation by skin contact

 In accordance with the Regulation (EC) No 1272/2008, the test item will be classified in category 1. The signal word “Warning” and hazard statement

 H317“May cause an allergic skin reaction”are required.

 In accordance with the Regulation (EC) No. 286/2011, the positive test item will be classified in sub-category 1A or 1B in accordance with the following table

	Criteria
Sub-category 1A	≥ 30 % responding at ≤ 0.1 % intradermal induction dose or ≥ 60 % responding at > 0.1 % to ≤ 1 % intradermal induction dose
Sub-category 1B	≥ 30 % to < 60 % responding at > 0.1 % to ≤ 1 % intradermal induction dose or ≥ 30 % responding at > 1 % intradermal induction dose

 

RESULTS

Concentrations selected 

Preliminary studies:

-MNNC determination:

No necrosis has been observed at the concentration of 2%. The first induction of the Group 2 has been carried out by intradermal injection at the maximal non necrosing concentration of 2% (Table 1 - attachment 1).

-Pre MNIC determination:

24 hours after the removal of the occlusive dressings, slight to moderate erythema was noted on the treated areas at 100% and 50%; no macroscopic cutaneous reaction was noted on the treated areas at 20% and 10% (Table 2 - attachment 2).

 

In view of these results, the concentration selected was 100% for the 2^ndinduction of the Group 2 and the MNIC determination began at the concentration of 20%.

 

-MNIC determination:

24 hours after the removal of the occlusive dressings, slight erythema was noted on the treated areas at 20% (3/3), 10% (3/3) and 5% (2/3). 24 and 48 hours after the removal of the occlusive dressings, no macroscopic cutaneous reaction was recorded on the treated area at 2.5% (Table 3 - attachment 2).

 

In view of this result, the concentrations selected were 2.5% (MNIC) and 1.25% (1/2 MNIC) for the challenge phase.

Main study:

-Induction phase Group 1:

The induction phase was performed by intradermal injection on D0 with olive oil and by topical application on D7 with liquid paraffin.

No cutaneous reaction was recorded after the induction phase (Appendix 4 - attachment 10).

-Induction phase Group 2:

The induction phase was performed by intradermal injection on D0 with the test item at 2% in olive oil and by topical application on D7 with the test item at 100%.

No cutaneous reaction was recorded after the first induction. Slight (7/10) to moderate (3/10) erythema was noted in ten animals (10/10), 24 hours after the second induction (Appendix 4 - attachment 10).

- Challenge phase Groups 1 & 2:

The test item has been used diluted at 2.5% and at 1.25% in liquid paraffin.

-Re-Challenge phase Groups 1 & 2:

The test item has been used diluted at 1% and at 0.5% in liquid paraffin.

Sensitising potential assessment

Overall results of the challenge phase with the test item (readings at 24, 48 and 72 hours) are givenin Table 4 (attachment3).

Individual scores of macroscopic evaluations performed during challenge phase with the test item are given inTable 5 (attachment 4).

In the treatment group (treatment dose of 2.5%), slight to moderate erythema was noted in 40% (4/10) and in 20% (2/10) of the animals from the treated group, 24 and 48 hours respectively after the challenge phase, on the treated area. Erythematous reactions were totally reversible at the reading time 72 hours.

In the control group (associated with the treatment dose of 2.5%), slight to moderate erythema was noted in 100% (5/5) and in 20% (1/5) of the animals from the control group, 24 and 48 hours respectively after the challenge phase, on the area challenged with the test item at 2.5%. Erythematous reactions were totally reversible at the reading time 72 hours.

In the treatment group (treatment dose of 1.25%), slight to moderate erythema was noted in 60% (6/10) and in 20% (2/10) of the animals from the treated group, 24 and 48 hours respectively after the challenge phase, on the treated area. Erythematous reactions were totally reversible at the reading time 72 hours.

In the control group (associated with the treatment dose of 1.25%), it was recorded a slight to moderate erythema in 100% (5/5) and in 20% (1/5) of the animals from the control group, 24 and 48 hours respectively after the challenge phase, on the area challenged with the test item at 1.25%. Erythematous reactions were totally reversible at the reading time 72 hours.

As irritation was observed in the control group animals, only reactions in the test group animals that exceeded the most severe reactions seen in the control group animals were attributed to skin sensitization. So, no sensitization reaction was noted in animals from the treated group with the test item at 2.5% and 1.25%.

In order to confirm these results, a re‑challenge phase was performedwith the test item diluted at 1% and 0.5% in liquid paraffin, after a rest phase of 6 days.

Overall results of the re-challenge phase with the test item (readings at 24 and 48 hours) are givenin Table 6 (attachment 5).

Individual scores of macroscopic evaluations performed during re-challenge phase with the test item are given inTable 7 (attachment 6).

In the treatment group (treatment dose of 1%), slight erythema was noted in 10% (1/10) of the animals from the treated group, only 24 hours after the re-challenge phase, on the treated area.

No cutaneous intolerance reaction was noted in animals from the negative control group after the re-challenge phase, on the treated area with the test item at 1%.

In the treatment group (treatment dose of 0.5%), slight erythema was noted in 10% (1/10) of the animals from the treated group, only 24 hours after the re-challenge phase, on the treated area.

No cutaneous intolerance reaction was noted in animals from the negative control group after the re-challenge phase, on the treated area with the test item at 0.5%.

Weight evolution

The weight gain of negative control animals (Group 1) and treated animals (Group 2) is presented in Tables 8 and 9 (attachments 7 and 8), respectively.

No abnormality was recorded in the body weight gain of both groups.

Mortality

No mortality was registered during the main test.

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In conclusion, under these experimental conditions, the test item Hamaca Synthetic Crude Oil composite sample (671/672/675) must not be classified as a skin sensitiser, in accordance with the criteria for classification, packaging and labelling of dangerous substances and preparations of the E.E.C. Directives 67/548, 2001/59 and 99/45. No symbol or warning label is required.

In accordance with the Regulation EC No 1272/2008, the test item must not be classified in category 1. No signal word or hazard statement is required.

Executive summary:

The aim of the study was to evaluate the possible allergenic activity of the test item after intradermal and topical administration in guinea pigs.

 

After induction (intradermal injection at 2% and topical application at 100%) of 10 Guinea Pigs oreated group with the test item Hamaca Synthetic Crude Oil composite sample (671/672/675) and a 10-day rest phase, the challenge phase, under occlusive dressing for 24 hours, consisted to a single topical application ohe test item diluted at 2.5% and 1.25% in liquid paraffin. The experimental protocol was established according to the OECD guideline No. 406 dated July 17^th, 1992 and the test method B.6 ohe council regulation No. 440/2008.

 

In the treatment group (treatment dose of 2.5%), slight to moderate erythema was noted in 40% (4/10) and in 20% (2/10) of the animals from the treated group, 24 and 48 hours respectively after the challenge phase, on the treated area. Erythematous reactions were totally reversible at the reading time 72 hours.

 

In the control group (associated with the treatment dose of 2.5%), slight to moderate erythema was noted in 100% (5/5) and in 20% (1/5) of the animals from the control group, 24 and 48 hours respectively after the challenge phase, on the area challenged with the test item at 2.5%. Erythematous reactions were totally reversible at the reading time 72 hours.

 

In the treatment group (treatment dose of 1.25%), slight to moderate erythema was noted in 60% (6/10) and in 20% (2/10) of the animals from the treated group, 24 and 48 hours respectively after the challenge phase, on the treated area. Erythematous reactions were totally reversible at the reading time 72 hours.

 

In the control group (associated with the treatment dose of 1.25%), slight to moderate erythema was noted in 100% (5/5) and in 20% (1/5) of the animals from the control group, 24 and 48 hours respectively after the challenge phase, on the area challenged with the test item at 1.25%. Erythematous reactions were totally reversible at the reading time 72 hours.

 

As irritation was observed in the control group animals, only reactions in the test group animals that exceeded the most severe reactions seen in the control group animals were attributed to skin sensitization. So, no sensitization reaction was noted in animals from the treated group with the test item at 2.5% and 1.25%.

 

In order to clarify these results, a new challenge phase was performedwith the test item diluted at 1% and 0.5% in liquid paraffin, after a rest phase of 6 days.

 

In the treatment group (treatment dose of 1%), slight erythema was noted in 10% (1/10) of the animals from the treated group, only 24 hours after the re-challenge phase, on the treated area.

 

No cutaneous intolerance reaction was noted in animals from the negative control group after the re-challenge phase, on the treated area with the test item at 1%.

 

In the treatment group (treatment dose of 0.5%), slight erythema was noted in 10% (1/10) of the animals from the treated group, only 24 hours after the re-challenge phase, on the treated area.

 

No cutaneous intolerance reaction was noted in animals from the negative control group after the re‑challenge phase, on the treated area with the test item at 0.5%.

 

In conclusion, under these experimental conditions, the test item Hamaca Synthetic Crude Oil composite sample (671/672/675)must not be classified as a skin sensitiser, in accordance with the criteria for classification, packaging and labelling of dangerous substances and preparations of the E.E.C. Directives 67/548, 2001/59 and 99/45. No symbol or warning label is required.

 

In accordance with the Regulation EC No 1272/2008, the test item must not be classified in category 1. No signal word or hazard statement is required.

        

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Justification for selection of skin sensitisation endpoint:
This test method was selected because the first-choice method according to REACH Annex VII §8.3, the Murine Local Lymph Node Assay, is known to give false positive results with hydrocarbon substances.