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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

C9-14 aliphatics (2-25% aromatics) were not dermal sensitizers using a Magnusson and Kligman Guinea-Pig Maximization test (OECD TG 406). C9-14 aliphatics (2-25% aromatics) were not dermal sensitizers in a Human Repeated Insult Patch Test (HRIPT).

Respiratory Sensitisation

no data

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:
experimental study
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.
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:
other: Not specified

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:
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, C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%). However, data is available for structural analogue, Hydrocarbons, C9-C12, n-alkanes, isoalkanes, cyclics, aromatics (2-25%). 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.

A skin sensitization study (Shell, 1977a) performed according to Magnusson and Kligman Guinea-Pig Maximization test (OECD TG 406) found no indication of skin sensitization in guinea pigs for C9-14 aliphatics (2-25% aromatics).

C9-14 aliphatics (2-25% aromatics) are not skin sensitizers in humans (ExxonMobil, 1962). C9-14 aliphatics (2-25% aromatics) were evaluated for its ability to induce skin sensitization in a 100+ person Human Repeated Insult Patch Test (HRIPT).

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

There are no reports of respiratory sensitization from Hydrocarbons, C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%) in laboratory animals or humans. However, a skin sensitization study utilizing C9-14 aliphatics (2-25% aromatics) found no indication of skin sensitization in guinea pigs. Additional studies in humans also found no indication of skin sensitization. With these observations, it is presumed that Hydrocarbons, C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%) will not be a respiratory sensitizing agent.


Justification for classification or non-classification

Based on available read across data, Hydrocarbons, C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%) 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).