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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.

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Toxicological information

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Administrative data

Description of key information

Based on available read across data (Buehler test (OECD TG 406)), Hydrocarbons, C16-C20, n-alkanes, isoalkanes, cyclics, aromatics (2-30%) is not considered to be a skin sensitizer.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1985
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: According to or similar to guideline study OECD 406: GLP.
Justification for type of information:
The justification for read across is provided as an attachment in IUCLID Section 13.
Reason / purpose for cross-reference:
read-across source
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.4 ml of 0.1% w/v suspension in acetone.
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.4 ml of 0.1% w/v suspension in acetone.. No with. + reactions: 0.0. Total no. in groups: 10.0.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.4 ml of 0.1% w/v suspension in acetone.
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.4 ml of 0.1% w/v suspension in acetone.. No with. + reactions: 0.0. Total no. in groups: 10.0.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 10.0.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 10.0.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
No. with + reactions:
20
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. No with. + reactions: 20.0. Total no. in groups: 20.0.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
No. with + reactions:
20
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. No with. + reactions: 20.0. Total no. in groups: 20.0.

The skin reactions after challenge applications were:

Test group - No dermal irritation in any animal;

Naive control group - Very slight erythema in two animals, no reaction in the other eight animals;

Vehicle control group - A very slight erythema in one animal, no reaction in the other nine animals;

Positive control group - Very slight to severe irritation in all 20 animals. The reaction in 19 animals exceeded the highest reaction observed in the naive positive control animals;

Naive positive control group - 5 of 20 animals exhibited very slight erythema, the other 15 animals had no skin reaction.

Interpretation of results:
other: Not sensitising
Conclusions:
Classification as a dermal sensitizer is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
Executive summary:

This data is being read across from the source study that tested Kerosene based on analogue read across.

0.4 ml undiluted test material was applied under an occlusive dressing to the shaved skin of 10 animals. Six hours after application, the dressing was removed and the skin wiped to remove residues of test material. The animals received one application each week for 3 weeks. 2 weeks following the third application a challenge dose (0.4 ml of a 1% solution in paraffin oil) was applied in the same manner as the sensitizing doses. A previously untreated site was used for the challenge application. Classification as a dermal sensitizer is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.

Endpoint:
skin sensitisation: in vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

There is no data available for Hydrocarbons, C16-C20 n-alkanes, isoalkanes, cyclics, aromatics (2-30%). However, data is available for structural analogue, Kerosene. An additional case study on sensitisation in humans for structural analogue, Hydrocarbons, C14 -C20, n-alkanes, isoalkanes, cyclics, aromatics (2 -30%) is also available. Petroleum substances of similar carbon number and aromatic content, principally kerosene and jet fuel, are typically in the range of C9-C16. These substances also contain similar types of molecules in similar proportions to those in C14-C20 aliphatic [2-30% Aromatics] Hydrocarbon solvents. In general, hydrocarbon solvents are more highly refined than petroleum substances. Accordingly, the petroleum substances typically represent a “worse case” with respect to hydrocarbon solvents and can be used for read across on that basis. This data is read across to based on analogue read across and a discussion and report on the read across strategy is provided as an attachment in IUCLID Section 13.

 

Kerosene

In a key Buehler test (API, 1985b) 0.4 ml undiluted test material (Kerosene; Straight run kerosene) was applied under an occlusive dressing to the shaved skin of 10 animals. Six hours after application, the dressing was removed and the skin wiped to remove residues of test material. The animals received one application each week for 3 weeks. 2 weeks following the third application a challenge dose (0.4 ml of a 1% solution in paraffin oil) was applied in the same manner as the sensitizing doses. A previously untreated site was used for the challenge application. Classification as a dermal sensitizer is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).

Sensitisation data (humans)

Hydrocarbons, C14 -C20, n-alkanes, isoalkanes, cyclics, aromatics (2 -30%)

In a supporting case study, a 64 year old woman had a history of an eczematous rash after the application of sunscreen. The rash had appeared after 3 days of application of the sunscreen over the face, neck, and limbs and had been very pruritic. Patch tests with the European standard series gave positive reactions to formaldehyde, quaternium-15, imidazolidinyl urea, and diazolidinl urea. The ingredients of the sunscreen were obtained from the manufacturers and patch tests were performed. There were positive reactions to isohexadecane 10% alcohol + at D2 and D4 and isopropyl myristate 10% alcohol + at D4. Both of these substances tested negatively in 20 controls. To the knowledge of the investigators, this is the first and only case report of allergic contact dermatitis from both isohexadecane and isopropyl myristate.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

There are no reports of respiratory sensitisation from Hydrocarbons, C16-C20, n-alkanes, isoalkanes, cyclics, aromatics (2-30%) in laboratory animals or from structural analogues in humans. However, the read across skin sensitisation study found no indication of skin sensitisation in guinea pigs.  With these observations, it is presumed that Hydrocarbons, C16-C20, n-alkanes, isoalkanes, cyclics, aromatics (2-30%) will not be a respiratory sensitising agent.

Justification for classification or non-classification

Based on available read across data, Hydrocarbons, C16-C20, n-alkanes, isoalkanes, cyclics, aromatics (2-30%) does not meet the criteria for classification as a skin or respiratory sensitizer under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).