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Description of key information

Based on read-across from a structurally related substance within a category approach, Hydrocarbons, C6-C10 (even numbered), n-alkanes, isoalkanes, >5% n-hexane are not considered to be a skin sensitiser.

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
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:
Scientifically valid and acceptable guinea pig maximisation test.
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
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:
negative control
Remarks on result:
other: control group data not specified
Key result
Group:
positive control
Remarks on result:
not measured/tested
Interpretation of results:
other: Not sensitising
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 are no skin sensitisation data available on Hydrocarbons, C6-C10 (even numbered), n-alkanes, isoalkanes, >5% n-hexane. However, there are reliable data available from a structurally related substance within a category approach. Thus, read-across was conducted based on an analogue-approach.

The skin sensitization potential of hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics, was studied in a guinea pig maximization test (Magnusson/Kligman method) similar to OECD 406. Guinea pigs (10/sex in treated group and 5/sex in control group) were induced with 1% (w/v) of the test substance in corn oil as a 0.1 ml injection in the shaved shoulder region. Six to eight days later a topical induction of 50% (w/v) test material was applied under an occlusive dressing for 48 hrs. On Day 20-21 guinea pigs were challenged with 25% (w/v) test material applied to the shaved flank. Skin response was evaluated immediately after challenge, and 24 and 48 hours later. The test substance did not cause indication of skin sensitization in any guinea pig at any evaluation period after challenge (Shell Chemicals, 1977c).

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

No data available.

Justification for classification or non-classification

Based on read-across from a structurally related substance within a category approach, the available data on the skin sensitisation potential of Hydrocarbons, C6-C10 (even numbered), n-alkanes, isoalkanes, >5% n-hexane are conclusive but not sufficient for classification.

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