MK1 Diesel Fuel

Skin sensitisation

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:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: This study is classified as reliable with restrictions because it is an acceptable and well-documented study report.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OTS 798.4100 (Skin Sensitisation)

GLP compliance:

yes

Type of study:

Buehler test

Justification for non-LLNA method:

The first-choice method according to REACH Annex VII §8.3, the Murine Local Lymph Node Assay, is known to give false positive results with hydrocarbon substances.

Test material

Test material information

Constituent 1

Reference substance name:

64742-81-0

IUPAC Name:

64742-81-0

Constituent 2

Reference substance name:

straight run kerosine

IUPAC Name:

straight run kerosine

Test material form:

other: low viscosity liquid hydrocarbon

Details on test material:

Straight run kerosine (F-131)

In vivo test system

Test animals

Species:

guinea pig

Strain:

Hartley

Sex:

male

Study design: in vivo (non-LLNA)

Induction

Route:

epicutaneous, occlusive

Vehicle:

other: Mineral oil

Challenge

Route:

epicutaneous, occlusive

Vehicle:

other: Mineral oil

No. of animals per dose:

10

Details on study design:

1st application: Induction undiluted occlusive epicutaneous
2nd application: Challenge 50 % occlusive epicutaneous

Positive control substance(s):

yes

Remarks:

dinitrochlorobenzene

Results and discussion

Positive control results:

DNCB evoked an acceptable positivve response

In vivo (non-LLNA)

Results

Results 1

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

1:2 v/v dilution

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

Severity Index (erythema + oedema) = 0.0

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1:2 v/v dilution . No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: Severity Index (erythema + oedema) = 0.0.

Results 2

Reading:

1st reading

Hours after challenge:

24

Group:

negative control

Dose level:

1:2 v/v dilution challenge control

No. with + reactions:

0

Total no. in group:

4

Clinical observations:

Severity Index (erythema + oedema) = 0.0

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 1:2 v/v dilution challenge control. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: Severity Index (erythema + oedema) = 0.0.

Results 3

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

1:2 v/v dilution

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

Severity Index (erythema + oedema) = 0.0

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1:2 v/v dilution . No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: Severity Index (erythema + oedema) = 0.0.

Results 4

Reading:

2nd reading

Hours after challenge:

48

Group:

negative control

Dose level:

1:2 v/v dilution challenge control

No. with + reactions:

0

Total no. in group:

4

Clinical observations:

Severity Index (erythema + oedema) = 0.0

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 1:2 v/v dilution challenge control. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: Severity Index (erythema + oedema) = 0.0.

Results 5

Reading:

2nd reading

Hours after challenge:

48

Group:

positive control

Dose level:

0.3% DNCB

No. with + reactions:

10

Total no. in group:

10

Remarks on result:

other: all animals reacted to challenge

Any other information on results incl. tables

The scores after the challenge treatment are summarised below

Group	Time	Severity range	Incidence
Test material	24 h	0	0/10
	48 h	0	0/10
Test control	24 h	0	4/4
	48 h	0	4/4
DNCB positive	24 h	4-6	10/10
	48 h	2-5	10/10
DNCB negative	24 h	0-2	4/4
	48 h	0-3	4/4
Mineral oil	24 h	0	0/4
	48 h	0	0/4

On the basis of the above response, the test material was not sensitizing.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this study, the test substance was classified as not sensitising.

Executive summary:

In a sensitisation study, test material was applied to the occluded skin of a group of 10 guinea pigs. Six hours after application, the patches were removed and an evaluation of skin response using the Draize scale was made 24 and 48 hours after patch application. A further group of 10 animals were treated with Dinitrochlorobenzene (DNCB) and these animals served as the positive control group. This procedure was repeated on the same test sites once each week for 3 weeks. Thirteen days after the last induction dose, test material or DNCB was again applied to the occluded skin on a fresh test site of either the test or positive control animals. Patches were removed after six hours and the test sites were assessed and scored for reaction 24 hours after patch application. At challenge, previously untreated groups of 4 animals were treated with either test material, DNCB or vehicle; these served as negative controls.

Response grades, including incidence and severity, at challenge phase were less than or equivalent to responses during induction phase. The responses of the treatment animals were the same as the challenge control group. Positive control groups responses indicate that a sensitising response occurred; therefore, DNCB is classified as a delayed contact sensitiser. However, under the conditions of this study, the test material is not a sensitising agent.