Registration Dossier

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
no
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): SBP 100/140
- Analytical purity:100% pure commercial product
- Composition of test material, percentage of components: SBP 100/140 consists of 35% C7, 50% C8, 15% C9 saturated hydrocarbon isomers. 65% n and isoparaffins, and 35% naphthenes.
- Other: Density = 0.73 g/cubic centimetre

Before the current ECHA nomenclature rules became effective, we adopted the IUPAC name Hydrocarbons, C7-9, n-alkanes, isoalkanes, cyclics (EC number 920-750-0) as the identifier for the substance and this was the name that was used during the pre-registration phase of REACH. Also during this time, samples of the product were collected and the required physicochemical studies were conducted. The resulting robust studies summaries were entered into the IUCLID dossier using this name and EC number.

Between 2008 and 2009 ECHA issued a specific document about the nomenclature to be used under REACH, the so called REACH Implementation Project 3.10. The implications of this document to the appropriate nomenclature for the registered substance were only fully understood by us beginning in late 2009/early 2010.

As such, during the creation of the robust study summaries in IUCLID, the discrepancy with the substance naming was not noticed. As a result, it appears in IUCLID that the tested substance indicated is not the same as the registered one; however, if robust study summaries and/or associated study reports use the substance name “Hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics,” they are actually referring to the registered substance “Hydrocarbons, C7-C8, n-alkanes” according to the revised REACH nomenclature rules.

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: p-strain
Sex:
male/female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
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
Challengeopen allclose all
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

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
0
Group:
test group
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.
Reading:
2nd reading
Hours after challenge:
24
Group:
test group
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.
Reading:
other: 3rd reading
Hours after challenge:
48
Group:
test group
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.

Applicant's summary and conclusion

Interpretation of results:
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.