Distillates (petroleum), heavy straight-run

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1985-01-02 to 1985-02-28

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study is classified as reliable without restrictions because it was conducted similar to OECD 406 guidelines and was GLP compliant.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Deviations:

no

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:

64741-44-2

Cas Number:

64741-44-2

IUPAC Name:

64741-44-2

Constituent 2

Reference substance name:

Straight run middle distillate

IUPAC Name:

Straight run middle distillate

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): Straight run middle distillate (API 83-11)
- Name of test material (as cited in study report): API 83-11
- Molecular formula (if other than submission substance): Straight run middle distillate
- Clear, light yellow liquid
- CAS number: 64741-44-2
- Gravity API: 36.2
- Sulfur wt %:0.30
- Nitrogen ppm: 80
- Boiling range (ASTM D-86 equiv) 10%: 488 °F
- Initial Boiling Point 366 °F
- End Boiling Point 735 °F
- Viscosity at 40°C cSt: 4.16
- Aniline Point °F: 171
- Composition % by MS:
olefins 2.0
aromatics 21.0
saturates 77.0

In vivo test system

Test animals

Species:

guinea pig

Strain:

Hartley

Sex:

male

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Hazelton Dutchland., Inc., Denver, Pennsylvania
- Age at study initiation: Approximately 9 to 10 weeks
- Weight at study initiation: 409 grams to 622 grams
- Housing: Individually
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: At least 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 to 24
- Humidity (%): 37% to 58%
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12 hours dark/12 hours light

IN-LIFE DATES: From: 1985-01-02 To: 1985-02-28

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

epicutaneous, occlusive

Vehicle:

paraffin oil

Induction 2

Concentration / amount:

Induction exposure was 0.4 millilitres of undiluted compound and challenge exposure was 0.4 millilitres of a 1% volume/volume in paraffin oil.

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

paraffin oil

Challenge 2

Concentration / amount:

Induction exposure was 0.4 millilitres of undiluted compound and challenge exposure was 0.4 millilitres of a 1% volume/volume in paraffin oil.

No. of animals per dose:

Ten for test compound and vehicle treatment and twenty for positive control

Details on study design:

RANGE FINDING TESTS: A range finding test was conducted on six animals using the test compound at concentrations of 1%, 10%, 25%, 50%, 75%, and 100% . Slight to well defined irritation occurred with the undiluted test compound, which was selected for the initiation exposure. Slight irritation occurred with one of the 1% applications, but not with the other so it was selected as the non-irritating dose for the challenge exposure.


MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: Three
- Exposure period: 6 hours
- Test groups: 0.4 millilitres undiluted induction followed by 0.4 millilitres 1% challenge
- Control group: Vehicle and positive controls
- Site: Back
- Frequency of applications: Once a week
- Duration: 3 weeks
- Concentrations: Undiluted


B. CHALLENGE EXPOSURE
- No. of exposures: One
- Day(s) of challenge: One
- Exposure period: 6 hours
- Test groups: test compound in paraffin oil
- Control group: Vehicle and positive controls
- Site: Back
- Concentrations: 1%
- Evaluation (hr after challenge): 24 and 48 hours

Challenge controls:

Ten animals were used as naive controls administered only the challenge dose of either the straight run middle distillate or the positive control.

Positive control substance(s):

yes

Remarks:

2,4-dinitrochlorobenzene

Results and discussion

Positive control results:

After the challenge exposure, all twenty animals exhibited slight to severe irritation that exceeded the highest response in naive positive controls in 18 of the 20 animals.

In vivo (non-LLNA)

Results

Results 1

Reading:

other: combined readings

Hours after challenge:

24

Group:

negative control

Dose level:

0

No. with + reactions:

0

Total no. in group:

10

Remarks on result:

other: Reading: other: combined readings. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.

Results 2

Reading:

other: combined readings

Hours after challenge:

24

Group:

test chemical

Dose level:

1%

No. with + reactions:

1

Total no. in group:

10

Remarks on result:

other: Reading: other: combined readings. . Hours after challenge: 24.0. Group: test group. Dose level: 1%. No with. + reactions: 1.0. Total no. in groups: 10.0.

Results 3

Reading:

other: combined readings

Hours after challenge:

24

Group:

positive control

Dose level:

0.34 w/v in 80% aqueous ethanol

No. with + reactions:

20

Total no. in group:

20

Clinical observations:

There was occasional soft stools in a few of the animals.

Remarks on result:

other: see Remark

Remarks:

Reading: other: combined readings. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.34 w/v in 80% aqueous ethanol. No with. + reactions: 20.0. Total no. in groups: 20.0. Clinical observations: There was occasional soft stools in a few of the animals..

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on these results, straight run middle distillate was not a skin sensitizer under the conditions of the test.

Executive summary:

A straight run middle distillate was tested using the Buehler method for dermal sensitisation in guinea pigs. The test substance (0.4 millilitres) was applied undiluted during the induction phase (three applications under occlusion, once per week for 3 weeks), and as a 1% volume/volume dilution in paraffin oil during the challenge phase, to groups of ten male guinea pigs. A positive control group (2,4-dinitrochlorobenzene in 80% aqueous ethanol, 0.3% for induction, 0.1% for challenge, as above in twenty animals), a vehicle control group (undiluted paraffin oil in ten animals) and a naive control (0.4 millilitres of 1% dilution of test sample during challenge only in ten animals) were also included in this study. The sites were examined for erythema and oedema at 24 and 48 hours following each application according to the method of Draize. Following challenge, very slight erythema was exhibited by a single animal however the intensity of the reaction did not exceed the highest response recorded in the naïve control animals. The other test animals exhibited no reaction following challenge. Positive controls had the appropriate response. Based on these results, straight run middle distillate was not a skin sensitizer under the conditions of the test.

This study received a Klimisch score of 1 and is classified as reliable without restrictions because it was conducted similar to OECD 406 guidelines and was GLP compliant.