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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Administrative data

Description of key information

Skin Sensitisation

Based on available read across data (Magnusson and Kligman Guinea-Pig Maximization tests (OECD TG 406)), Hydrocarbons, C10-C13, n-alkanes, isoalkanes, cyclics, aromatics (2-25%) is not considered to be a skin sensitiser.

Respiratory Sensitisation

No data available

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:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given:comparable to guidelines/standards.
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: supporting information
Reason / purpose for cross-reference:
reference to same study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Principles of method if other than guideline:
Magnusson, B, and Kligman, AM, (1969). The identification of contact allergens by animal assay. The guinea-pig maximization test. J. Invest. Derm., 52, 268-276.
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
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Shell Toxicology Laboratory, Breeding Unit
Route:
intradermal and epicutaneous
Vehicle:
corn oil
Concentration / amount:
Intradermal induction: 0.1 % w/v in corn oil
Topical induction: 50.0 % w/v in corn oil
Topical challenge: 25.0 % w/v in corn oil
Route:
other: epicutaneous
Vehicle:
corn oil
Concentration / amount:
Intradermal induction: 0.1 % w/v in corn oil
Topical induction: 50.0 % w/v in corn oil
Topical challenge: 25.0 % w/v in corn oil
No. of animals per dose:
10 males and 10 females were used in the exposure group
5 males and 5 females were used in the control group
Key result
Reading:
1st 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
Remarks on result:
other: Reading: 1st 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.
Key result
Reading:
2nd 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
Remarks on result:
other: Reading: 2nd 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.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
Group:
positive control
Remarks on result:
not measured/tested

Skin Response After Challenge Procedure

Animal – Exposure Group

Immediate

24 hrs

48 hrs

Male 1

-

-

-

Male 2

-

-

-

Male 3

-

-

-

Male 4

-

-

-

Male 5

-

-

-

Male 6

-

-

-

Male 7

-

-

-

Male 8

-

-

-

Male 9

-

-

-

Male 10

-

-

-

Female 1

-

-

-

Female 2

-

-

-

Female 3

-

-

-

Female 4

-

-

-

Female 5

-

-

-

Female 6

-

-

-

Female 7

-

-

-

Female 8

-

-

-

Female 9

-

-

-

Female 10

-

-

-

Control Group

Male 1

-

-

-

Male 2

-

-

-

Male 3

-

-

-

Male 4

-

-

-

Male 5

-

-

-

Female 1

-

-

-

Female 2

-

-

-

Female 3

-

-

-

Female 4

-

-

-

Female 5

-

-

-
Interpretation of results:
other: Not sensitising
Conclusions:
The test substance did not cause any skin response during the challenge procedure. The test substance is considered not sensitizing.
Executive summary:

This study examined the skin sensitization potential of Dilutene M5. Groups of 10 male and 10 female guinea pigs were induced with 0.1 % w/v of test substance in corn oil intradermally. 5 male and 5 female guinea pigs served as controls. The topical induction was performed with 50% w/v of test substance in corn oil. A topical challenge was then done with 25% w/v of test substance in corn oil. Animals were then scored for dermal reactions. No reaction was seen in any animal at any time during the experiment. The test substance is not sensitizing to skin.

Endpoint:
skin sensitisation: in vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

There is no data available for Hydrocarbons, C10-C13, n-alkanes, isoalkanes, cyclics, aromatics (2-25%). However, data is available for structural analogue, Hydrocarbons, C9-C12, n-alkanes, isoalkanes, cyclics, aromatics (2-25%). Additional skin sensitisation data in humans is available for structural analogue, C9-C14 aliphatics (2-25% aromatics). 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.

 

Hydrocarbons, C9-C12, n-alkanes, isoalkanes, cyclics, 2-25% aromatics

In a skin sensitization study (Shell, 1977a) performed according to Magnusson and Kligman Guinea-Pig Maximization test (OECD TG 406), groups of 10 male and 10 female guinea pigs were induced with 0.1 % w/v of test substance (Hydrocarbons, C9-C12, n-alkanes, isoalkanes, cyclics, 2-25% aromatics) in corn oil intradermally. 5 male and 5 female guinea pigs served as controls. The topical induction was performed with 50% w/v of test substance in corn oil. A topical challenge was then done with 25% w/v of test substance in corn oil. Animals were then scored for dermal reactions. No reaction was seen in any animal at any time during the experiment. Hydrocarbons, C9-C12, n-alkanes, isoalkanes, cyclics, 2-25% aromatics is not sensitizing to skin.

 

C9-C14 aliphatics (2-25% aromatics)

C9-14 aliphatics (2-25% aromatics) were evaluated for skin irritating properties in humans following a simulated use patch technique (ExxonMobil, 1962). A total of 101 subjects, including males and females, participated in the program. Each subject was patch tested before and after a three-week simulated use period. Under conditions and procedures used in the investigation C9-14 aliphatics (2-25% aromatics) will not be considered primary skin irritants under semi-occluded conditions. None of the test materials produced skin fatigue on repeated daily application during a three-week simulated use period. None of the test materials were skin sensitizers.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

There are no reports of respiratory sensitisation from Hydrocarbons, C10-C13, n-alkanes, isoalkanes, cyclics, aromatics (2-25%) 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, C10-C13, n-alkanes, isoalkanes, cyclics, aromatics (2-25%) will not be a respiratory sensitising agent.


Justification for classification or non-classification

Based on available read across data, Hydrocarbons, C10-C13, n-alkanes, isoalkanes, cyclics, aromatics (2-25%) does not meet the criteria for classification as a skin or respiratory sensitiser under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).