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Administrative data

Description of key information

Skin sensitisation

Based on available read across data, Hydrocarbons, C6 -C7, n-alkanes, isoalkanes, cyclics, <5% n-hexane is not considered to be a skin sensitizer.

Respiratory sensitisation

No data available

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of 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: Basic data given
Justification for type of information:
A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
Reason / purpose for cross-reference:
read-across: supporting information
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Acceptable guinea pig maximisation test that followed sound scientific principles.
Species:
guinea pig
Strain:
other: p-strain
Sex:
male/female
Route:
intradermal and epicutaneous
Vehicle:
corn oil
Concentration / amount:
1 % w/v in corn oil for intradermal induction
50 % for topical induction
25 % for topical challenge
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
1 % w/v in corn oil for intradermal induction
50 % for topical induction
25 % for topical challenge
No. of animals per dose:
20 (10 males, 10 females), controls: 10 (5 males, 5 females)
Positive control substance(s):
no
Key result
Group:
negative control
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
0
Group:
test chemical
Dose level:
25 % w/v in corn oil
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no skin sensitization
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 0.0. Group: test group. Dose level: 25 % w/v in corn oil. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no skin sensitization.
Key result
Reading:
2nd reading
Hours after challenge:
24
Group:
test chemical
Dose level:
25 % w/v in corn oil
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no skin sensitization
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25 % w/v in corn oil. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no skin sensitization.
Key result
Reading:
other: 3rd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25 % w/v in corn oil
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no skin sensitization
Remarks on result:
other: Reading: other: 3rd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25 % w/v in corn oil. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no skin sensitization.
Key result
Group:
positive control
Remarks on result:
not measured/tested
Interpretation of results:
other: not sensitising
Remarks:
Migrated information
Conclusions:
The purpose of this study was to determine the skin sensitization potential of the test substance, hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics. Ten male and ten female guinea pigs were used as a test group, and five male and five female guinea pigs were used as a control group. The test group underwent an intradermal induction of 1.0 %w/v test material in corn oil. Then a topical induction of 50% w/v test substance in corn oil. The challenge was done with 25% w/v test material in corn oil. No skin reactions were noted during the challenge. The test substance is not sensitizing.
Executive summary:

The purpose of this study was to determine the skin sensitization potential of the test substance, hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics. Ten male and ten female guinea pigs were used as a test group, and five male and five female guinea pigs were used as a control group. The test group underwent an intradermal induction of 1.0 %w/v test material in corn oil. Then a topical induction of 50% w/v test substance in corn oil. The challenge was done with 25% w/v test material in corn oil. No skin reactions were noted during the challenge. The test substance is not sensitizing.

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

There is no skin sensitisation data available for Hydrocarbons, C6 -C7, n-alkanes, isoalkanes, cyclics, <5% n-hexane. However, data is available for structural analogues Hydrocarbons, C7 -C9, isoalkanes and Hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics. This data is read across to Hydrocarbons, C6 -C7, n-alkanes, isoalkanes, cyclics, <5% n-hexane based on analogue read across and a discussion and report on the read across strategy is provided as an attachment in IUCLID Section 13.

 

Hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics

A key study (Shell, 1977) was conducted to determine the skin sensitization potential of the test substance, Hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics. Ten male and ten female guinea pigs were used as a test group, and five male and five female guinea pigs were used as a control group. The test group underwent an intradermal induction of 1.0 %w/v test material in corn oil. Then a topical induction of 50% w/v test substance in corn oil. The challenge was done with 25% w/v test material in corn oil. No skin reactions were noted during the challenge. The test substance is not sensitizing.

Human Data

Hydrocarbons, C7-C9, isoalkanes, <2% aromatics

There is human data available for skin sensitisation on hydrocarbons, C7-C9, isoalkanes. The human data show that there was no evidence that the test material possesses a skin sensitising potential (Exxon Mobil, 1962d, Exxon Mobil, 1988a) or is a photosensitiser (Exxon Mobil, 1988b).

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

There are no reports of respiratory sensitisation from Hydrocarbons, C6 -C7, n-alkanes, isoalkanes, cyclics, <5% n-hexane in laboratory animals or in humans. However, the read across skin sensitisation studies found no indication of skin sensitisation.  With these observations, it is presumed that Hydrocarbons, C6 -C7, n-alkanes, isoalkanes, cyclics, <5% n-hexane will not be a respiratory sensitising agent. Additional studies in humans also found no indication of skin sensitization. With these observations, it is presumed that Hydrocarbons, C6 -C7, n-alkanes, isoalkanes, cyclics, <5% n-hexane will not be a respiratory sensitizing agent.

Justification for classification or non-classification

Based on available read across data, Hydrocarbons, C6 -C7, n-alkanes, isoalkanes, cyclics, <5% n-hexane 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).