Middle distillate from refinery proces cofeeding vegetable oil

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:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

#2 home heating oil (50% catalytically-cracked)

IUPAC Name:

#2 home heating oil (50% catalytically-cracked)

Details on test material:

- Name of test material (as cited in study report): API #78-4, #2 home heating oil (50% cat)
- Substance type: petroleum distillation 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: 50% virgina gas oil and 50% cracked gas oil
- 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 provided by sponsor
- Storage condition of test material: 30 mL was removed from Elars' test material storage room and placed in an amber vial in the study room for the duration of the test.

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
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 11 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:

no data

Induction 2

Concentration / amount:

0.5 mL of undiluted test material

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

no data

Challenge 2

Concentration / amount:

0.5 mL of undiluted test material

No. of animals per dose:

10 animals per dose

Details on study design:

RANGE FINDING TESTS: not reported

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10 exposures
- Exposure period: 6 hours
- Test groups: 1 group of 10 animals
- Control group: 1 group of 10 animals
- Site: back of guinea pigs
- Frequency of applications: 3 times per week
- Duration: 3 weeks
- Concentrations: 0.5 mL of undiluted test material


B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 2 weeks after last induction exposure
- Exposure period: 6 hours
- Test groups: 1 group of 10 animals
- Control group: 1 group of 10 animals
- Site: backs of guinea pigs
- Concentrations: 0.5 mL of undiluted test material
- Evaluation (hr after challenge): 24 hours

Positive control substance(s):

yes

Remarks:

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:

1.1 average erythema score and 0.5 average oedema score

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: 1.1 average erythema score and 0.5 average oedema score.

Results 2

Reading:

1st reading

Hours after challenge:

24

Group:

positive control

Dose level:

0.05% w/v dilution of chlorodinitrobenzene

No. with + reactions:

10

Total no. in group:

10

Clinical observations:

mean erythema = 1.9

Remarks on result:

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

Any other information on results incl. tables

Phase	Average Dermal Irritation Score
	API #78-4		Positive Control
	Erythema	Oedema	Erythema	Oedema
Induction Phase Average	1.0	0.3	1.3	0.3
Challenge Phase Average	1.1	0.5	1.9	0.7

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information

Conclusions:

In a skin sensitisation study, there were no statistically significant differences between the mean of the averages of the ten sensitising treatments and the mean of the challenge treatment for wither erythema or oedema in the test or control group. Based on these results, the test material is considered non-sensitising.

Executive summary:

In a skin sensitisation study, ten young adult male albino rabbits were exposed to 0.5 mL of undiluted test material in the treatment group and ten

ten young adult male albino rabbits 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 backs approximately 3" x 3" in size. 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 sensitising 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 restriction because it was conducted similar to guideline study OECD 406.