Petrolatum

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

1985-08-20 to 1986-02-06

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: This study is classified as reliable with restrictions because it is an acceptable, well-documented study report which meets basic scientific principles.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

24hr occluded exposure

Principles of method if other than guideline:

The test procedure was consistent with that given in OECD 404; however, the following deviations are noted. Animals were exposed to the test material for 24 hours under occlusion. Current guidelines state that animals should only be exposed for 4 hours under a semi-occlusion. Additionally, the skin of some animals was abraded. Current guidelines recommend that skin be left intact.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

64741-50-0

Cas Number:

64741-50-0

IUPAC Name:

64741-50-0

Constituent 2

Reference substance name:

Unrefined light paraffinic distillate

IUPAC Name:

Unrefined light paraffinic distillate

Test material form:

other: oily liquid

Details on test material:

- Name of test material (as cited in study report): API 84 -01
- Substance type: Unrefined light paraffinic oil
- CAS number: 64741-50-0

Light paraffinic distillate, API 84-01, CAS No. 64741-50-0
- Molecular weight (if other than submission substance): 296
- Physical state: Liquid (light amber)
- CAS number: 64741-50-0
- Viscosity, cSt: 2.67 at 100°C
- API Gravity: 31.5
- Flash Point: (°F) 372
- Sulfur, Wt %: 0.2
- Nitrogen ppm: 256
- Distillation ASTM D 86 equivalent (°F) range: 601-803 (10-95%)
- Initial Boiling Point (°F): 579
- Composition of test material, Wt. %:
Olefins: 39.7
Naphthenes 21.7
- PONA % by MS: 37

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hazleton Dutchland, Inc., Denver, Pennsylvania
- Age at study initiation: 14 weeks
- Weight at study initiation: 2521 to 3102 grams
- Housing: Individually, screen-bottom cages
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 to 24 degrees Celsius
-Humidity (%): 56% to 70%
- Photoperiod (hrs dark / hrs light): 12 hour/ 12 hour

Test system

Type of coverage:

occlusive

Preparation of test site:

other: abraded or shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 millilitre per area

Duration of treatment / exposure:

24 hours under occlusion

Observation period:

Animals were observed 24 hours, 72 hours, 96 hours, 7 days and 14 days after the initial 24 hour exposure.

Number of animals:

Six animals were used in this study.

Details on study design:

TEST SITE
- Type of wrap if used: 2.5cm x 2.5cm gauze patch, secured with paper tape and over wrapped with Saran Wrap and Elastoplast tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped with wet disposable paper towels
- Time after start of exposure: 24 hours

SCORING SYSTEM: Draize technique

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24 and 72 hours

Score:

4.3

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

24 h

Score:

2.33

Max. score:

4

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: intact skin

Results 3

Irritation parameter:

erythema score

Basis:

mean

Time point:

48 h

Remarks on result:

not measured/tested

Results 4

Irritation parameter:

erythema score

Basis:

mean

Time point:

72 h

Score:

1.83

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:

24 h

Score:

2.33

Max. score:

4

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: intact skin

Results 6

Irritation parameter:

edema score

Basis:

mean

Time point:

48 h

Remarks on result:

not measured/tested

Results 7

Irritation parameter:

edema score

Basis:

mean

Time point:

72 h

Score:

1.67

Max. score:

4

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: intact skin

Any other information on results incl. tables

When applied undiluted at a level of 0.5 mL/area to intact or abraded shaved skin patches under occlusion for 24 hours, the test substance gave a primary dermal irritation index of 4.3. The test substance was judged by the authors to be irritating. 

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Not classified; exposure period was 24 hours under occlusion Criteria used for interpretation of results: EU

Conclusions:

Followiing application to clipped rabbit skin under occluded dressing the materal caused mild to moderate irritation. Based on the level of reaction and the the fact that the test site was occluded, it was considered that the material did not meet the EU criteria for classification as irritant.

Executive summary:

Read across justification

No skin irritation studies have been reported for petrolatum (carcinogenic or unknown feed-stock), but data have been reported for unrefined / acid treated lubricant base oils, materials similar to the oil entrained in petrolatum (carcinogenic or unknown feed-stock).

In a primary dermal irritation study, six, 14 week New Zealand White rabbit were dermally exposed to 0.5mL of API 84 -01 for 24 hours. Both intact and abraded skin was treated and observed for a total of 14 days. Erythema and oedema irritation was scored by the method of Draize.

In this study, API 84 -01 was found to be a dermal irritant to the skin based on the primary dermal irritation index score of 4.3. Mean erythema and oedema scores over 72 hours (i.e., average of 24 and 72 hour readings) for intact skin was 2.08 for both endpoints. Mean erythema and oedema scores over the same time period for abraded skin were 2.25 and 2.17, respectively.

This study received a Klimisch score of 2 and is classified as reliable with restriction because the study is acceptable and well-documented study report which meets basic scientific principles.