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Diss Factsheets

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
This endpoint has been reviewed, assessed and accepted by UK-HSE as competent authority for the notification of a new substance [EC number: 481-730-0; Data from UK-Notification Dossier by Shell U.K. Limited in accordance with Directive 92/32/EEC (Articles 7/8/9/12) O.J.L 154, Volume 35, 5 June 1992; Notification Report 06-31-0125-00 from 1st Nov, 2006].

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Principles of method if other than guideline:
only 10 animals were used in the treatment group (instead of a minimum of 20 animals)
GLP compliance:
yes
Remarks:
American Petroleum Institute
Type of study:
Buehler test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): API-83-19, which is Naphtha (petroleum), light alkylate [CAS 64741-66-8]
- Substance type: test substance API-83-19 is a near analogue to Naphta (Fischer-Tropsch), light, C4-10 - branched and linear; it`s defined as:
'A complex combination of hydrocarbons produced by the distillation of the reaction products of isobutane with monoolefinic hydrocarbons usually ranging in carbon numbers from C3 through C5. It consists of predominantly branched chain saturated hydrocarbons having carbon numbers
predominantly in the range of C7-C10 and boiling in the range 90-160°C (194-320°F).'
--> the test substance API 83-19 is comparable to 'Naphtha (Fischer-Tropsch), light, C4-10 - branched and linear' and therefore read across is
valid.

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
paraffin oil
Concentration / amount:
Concentrations of test material and vehicle used at each stage of induction:
- Test material: 50% v/v in paraffin oil
- Vehicle control: paraffin oil undiluted
Concentrations of test material and vehicle used at each stage of challenge:
- Test material: 25% v/v in paraffin oil
- Vehicle control: paraffin oil undiluted
- Naive control: 25% v/v test material in paraffin oil
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
paraffin oil
Concentration / amount:
Concentrations of test material and vehicle used at each stage of induction:
- Test material: 50% v/v in paraffin oil
- Vehicle control: paraffin oil undiluted
Concentrations of test material and vehicle used at each stage of challenge:
- Test material: 25% v/v in paraffin oil
- Vehicle control: paraffin oil undiluted
- Naive control: 25% v/v test material in paraffin oil
No. of animals per dose:
- test group: 10
- naive control group: 10
- vehicle control group: 10
- positive control group: 20
- naive positive control group: 20

Study design: in vivo (LLNA)

Positive control substance(s):
other: 2,4-Dinitrochlorobenzene

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
other: mean of 1st and 2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25% v/v
No. with + reactions:
1
Total no. in group:
10
Clinical observations:
slight erythema
Remarks on result:
other: Reading: other: mean of 1st and 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25% v/v. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: slight erythema .
Reading:
other: mean of 1st and 2nd reading
Hours after challenge:
48
Group:
other: naive control group
Dose level:
25% v/v
No. with + reactions:
1
Total no. in group:
10
Clinical observations:
slight erythema
Remarks on result:
other: Reading: other: mean of 1st and 2nd reading. . Hours after challenge: 48.0. Group: other: naive control group. Dose level: 25% v/v. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: slight erythema.
Reading:
other: mean of 1st and 2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
paraffin only
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
-
Remarks on result:
other: Reading: other: mean of 1st and 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: paraffin only. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: -.
Reading:
other: mean of 1st and 2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
0,1% w/v
No. with + reactions:
20
Total no. in group:
20
Clinical observations:
very slight erythema and edema
Remarks on result:
other: Reading: other: mean of 1st and 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 0,1% w/v. No with. + reactions: 20.0. Total no. in groups: 20.0. Clinical observations: very slight erythema and edema.
Reading:
other: mean of 1st and 2nd reading
Hours after challenge:
48
Group:
other: naive positive control group
Dose level:
0,1% w/v
No. with + reactions:
3
Total no. in group:
20
Clinical observations:
very slight erythema
Remarks on result:
other: Reading: other: mean of 1st and 2nd reading. . Hours after challenge: 48.0. Group: other: naive positive control group. Dose level: 0,1% w/v. No with. + reactions: 3.0. Total no. in groups: 20.0. Clinical observations: very slight erythema.

Any other information on results incl. tables

Observations

- Test group: A very slight erthyema reaction was exhibited by one animal. The reaction did not exceed the highest reaction of the naive control animals.The other nine animals exhibited no reaction.

- Naive control group: A very slight erthyema reaction was exhibited by one animal. The other nine animals exhibited no reaction.

- Negative control group: No reaction was exhibited by any animal.

- Positive control group: Very slight to severe irritation was exhibited by all 20 animals. The reactions of 18 animals exceeded the highest reaction observed in the naive positive control animals.

- Naive positive control group: Three of the 20 animals exhibited very slight erythema reactions. The other 17 animals exhibited no reaction.

Other observations:

- All animals appeared normal throughout the study period with the exception of two test animals, five positive control animals, and two naive

control animals which exhibited soft stool/diarrhea sporadically throughout the study.

- A slight bodyweight loss of 5g was recorded during the last week of the study for one test animal. This animal exhibited normal bodyweight gains at all other weighings. Normal bodyweight gains were recorded for all other animals during the study.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
- Skin reactions to the induction dose: Slight to moderate erythema and slight edema were observed in the animals dosed with test material.
- Skin reactions to the challenge dose: the test group did not show any skin reaction, like erythema and edema after challange, except 1 out of 10
animals.
Result: It was concluded that, under the conditions of this study, repeated administration of 'Naphtha (petroleum), light alkylate', a structural
analogue to 'Naphtha (Fischer-tropsch), light, C4-10 - branched and linear', also had a weak potential to cause delayed contact hypersensitivity in
guinea pigs. However, the incident of significant response was below the EEC trigger threshold for classification as a dermal sensitizer.