Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across based on grouping of substances (category approach)
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

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:

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.