Distillates (petroleum), hydrotreated middle

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1981-11-12 to 1982-08-14

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 a well-documented study report.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1993

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

Primary dermal irritation score includes scores from abraded skin. OECD TG 404 does not recommend testing on abraded skin. Also the test involved 24hr occluded exposure

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

64742-80-9

Cas Number:

64742-80-9

IUPAC Name:

64742-80-9

Constituent 2

Reference substance name:

Hydrodesulfurised middle distillate

IUPAC Name:

Hydrodesulfurised middle distillate

Test material form:

other: low viscosity liquid hydrocarbon

Details on test material:

- Name of test material (as cited in study report): API 81-10 (CAS# 64742-80-9)
- Physical state: yellow liquid
- Gravity API: 34.9
- Sulfur wt %:0.28
- Nitrogen ppm: 97
- Flash pt. °F: 160
- Boiling range (ASTM D-86) 10-95%: 421-637 °F
- Initial Boiling Point 342 °F
- End Boiling Point 651 °F
- Composition %:
paraffins 48.9
olefins 0
naphthenes 20.2
aromatics 30.9

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dutchland Laboratories, Inc., Denver, Pennsylvania
- Age at study initiation: At least 14 weeks of age
- Weight at study initiation: The average body weight at initiation was 2824 g
- Housing: Individually in screen bottom cages.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: atleast 14 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 21 degrees Celsius
- Humidity (%): 36% to 68% relative humidity
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12 hours dark/ 12 hours light

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL per abraded area and intact area

VEHICLE - material was used as supplied.

Duration of treatment / exposure:

24 hours

Observation period:

Erythema and edema were recorded 24 hours after exposure and 72, 96 hours and at 7 and 14 days.

Number of animals:

Six male rabbits

Details on study design:

TEST SITE
- Area of exposure: back of the animals.
- % coverage: not reported
- Type of wrap if used: Each area was covered with gauze patch, then secured with paper tape and over wrapped with Saran wrap and Elastoplast tape.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Material was wiped, not washed.
- Time after start of exposure: 24 hours


SCORING SYSTEM: Draize technique.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24 h

Score:

1.8

Max. score:

4

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: intact skin

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

48 h

Remarks on result:

not measured/tested

Results 3

Irritation parameter:

erythema score

Basis:

mean

Time point:

72 h

Score:

3.7

Max. score:

4

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: intact skin

Results 4

Irritation parameter:

edema score

Basis:

mean

Time point:

24 h

Score:

3.2

Max. score:

4

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: intact skin

Results 5

Irritation parameter:

edema score

Basis:

mean

Time point:

48 h

Remarks on result:

not measured/tested

Results 6

Irritation parameter:

edema score

Basis:

mean

Time point:

72 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: intact skin

Other effects:

Blanching of the test sites was noted in 2 animals exposed to test material at 24 hours and in 5 animals exposed to test material at 72 and 96 hours. Desquamation was present in 1-2 animals at the 72 and 96 hour observation periods.

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The mean erythema and oedema scores (24 and 72 hours) of 2.75 and 3.1 respectively, suggests that hydrodesulfurised middle distillates are irritating to skin after 24 hour occluded contact.

Executive summary:

In a primary dermal irritation study, six male, young adult New Zealand White Strain rabbits were dermally exposed to 0.5 mL of test material (hydrodesulfurised middle distillate) for 24 hours. Animals then were observed for 14 days. Irritation was scored by the method of Draize.

In this study the test material is a dermal irritant to the skin based on the mean erythema and oedema scores (24 and 72 hours) of 2.75 and 3.1 respectively.

This publication is classified as Klimisch score 2, reliable with restrictions because it is an acceptable and a well-documented study report.