Fuel oil, no. 2

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1979-09-21 to 1979-10-27

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: This study is classified as reliable with restrictions because it was conducted similar to guideline study OECD 406.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

GLP compliance:

not specified

Type of study:

other: buehler type dermal application

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:

68334-30-5

Cas Number:

68334-30-5

IUPAC Name:

68334-30-5

Constituent 2

Reference substance name:

Diesel fuel -marketplace sample

IUPAC Name:

Diesel fuel -marketplace sample

Test material form:

other: low viscosity hydrocarbon liquid

Details on test material:

- Name of test material (as cited in study report): API #79-6, disel fuel (marketplace sample)
- Substance type: petroleum distillate product composed of hydrocarbon chains
- Physical state: liquid
- Analytical purity: not provided by sponsor
- Impurities (identity and concentrations): not reported
- Composition of test material, percentage of components wt percent: 41.7% paraffins, 30.9% cycloparaffins (monocycloparaffins 18.8% dicycloparaffins 9.3%, tricycloparaffins 2.8%) 27.4% aromatics (alkylbenzenes 8.4%, indans and tetralins 5.3%, dinaphthenobenzenes 1.1%, C11+ naphthalenes 7.6%, biphenylenes 2.5% fluorenes etc 1.1% tricyclic aromatics 1.4%)
- Isomers composition: not reported
- Purity test date: not reported
- Lot/batch No.: not reported
- Expiration date of the lot/batch: not reported
- Stability under test conditions: not reported by sponsor
- Storage condition of test material: stored in Elars' test material storage room
- Flash Point: 142 °F
- Sulfur 0.19%
- Viscosity at 100°F: 2.17 cSt
- Bromine number 1.42
- benzene 80 ppm v/v
- acid number 0.0
- Distillation range (ASTM D-86) 5-95%: 412-648 °F
- Initial BP: 367 °F
- Final Boiling Point: 675°F

In vivo test system

Test animals

Species:

guinea pig

Strain:

other: albino

Sex:

male

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: CAMM Research Institute
- Age at study initiation: young adult
- Weight at study initiation: not reported
- Housing: housed in stainless steel cages with indirect bedding
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 10 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): not reported
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): not reported


IN-LIFE DATES: not reported

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

epicutaneous, occlusive

Vehicle:

unchanged (no vehicle)

Induction 2

Concentration / amount:

0.5 mL of undiluted test material

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

unchanged (no vehicle)

Challenge 2

Concentration / amount:

0.5 mL of undiluted test material

No. of animals per dose:

10 treatment animals and 10 positive control animals

Details on study design:

RANGE FINDING TESTS: not reported

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10
- Exposure period: 6 hours
- Test groups: 10 animals in treatment group
- Control group: 10 animals in positive control group
- Site: back
- Frequency of applications: three times per week
- Duration: three weeks
- Concentrations: undiluted


B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: two weeks after induction period
- Exposure period: 6 hours
- Test groups: 10 animals in treatment group
- Control group: 10 animals in positive control group
- Site: backs
- Concentrations: undiluted
- Evaluation (hr after challenge): 24 hours

Positive control substance(s):

yes

Remarks:

0.05% (w/v) dilution of chlorodinitrobenzene in ethanol

Results and discussion

Positive control results:

No statistically significant differences between the mean of the averages of the ten sensitizing treatments and the mean of the challenge treatment for either erythema or oedema in the control group.

In vivo (non-LLNA)

Results

Results 1

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

undiluted

No. with + reactions:

10

Total no. in group:

10

Clinical observations:

Average erythema score of 1.3 and average oedema score of 0.3.

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: undiluted. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: Average erythema score of 1.3 and average oedema score of 0.3..

Results 2

Reading:

1st reading

Hours after challenge:

24

Group:

positive control

Dose level:

0.05% w/v dilution of chlorodinitrobenzene in ethanol

No. with + reactions:

10

Total no. in group:

10

Clinical observations:

Average erythema score = 1.9, Average oedema score = 0.7

Remarks on result:

other: see Remark

Remarks:

Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.05% w/v dilution of chlorodinitrobenzene in ethanol. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: Average erythema score = 1.9, Average oedema score = 0.7 .

Results 3

Reading:

other: not tested

Group:

negative control

Remarks on result:

not measured/tested

Any other information on results incl. tables

Phase	Average Dermal Irritation Score
	API #79 -6		Positive Control
	Erythema	Oedema	Erythema	Oedema
Induction Phase Average	1.3	0.3	1.3	0.3
Challenge Phase Average	1.3	0.3	1.9	0.7

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Results indicated no statistically significant differences between the mean of the averages of the ten sensitizing treatments and the mean of the challenge treatment for either erythema or oedema in the test or control group. Based on this data, the test material is considered non-sensitising.

Executive summary:

In a skin sensitisation study, ten young adult male albino guinea pigs were exposed to 0.5 mL of undiluted diesel fuel (marketplace sample) in the treatment group and ten young adult male albino guinea pigs were exposed to 0.05% (w/v) dilution of chlorodinitrobenzene in ethanol in the positive control group. Both groups were shaved in an area on their back. On the day of application, test material or positive control was placed on a gauze patch which was put on the shaved exposure site, covered with plastic wrap and wrapped with elastic bandaging. Bandaging and wrapping was removed 6 hours after application. The same procedure was replicated 3 times a week for 3 weeks (10 treatments in total). Two weeks after the last induction dose, a single challenge dose was administered following the same methods as used during the induction period, in both the treatment and positive control groups. Scoring of erythema and oedema was made at 24 hours after each application.

Results indicated no statistically significant differences between the mean of the averages of the ten sensitizing treatments and the mean of the challenge treatment for wither erythema or oedema in the test or control group. Based on this data, the test material is considered non-sensitising.

This study received a Klimisch score of 2 and is classified as reliable with restrictions because it was conducted similar to guideline study OECD 406.