Petrolatum (petroleum), oxidized, calcium salt

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation / corrosion, other

Remarks:

in vivo study, since in vitro studies were not available at that time

Type of information:

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

Adequacy of study:

key study

Study period:

2003-09-26 to 2003-12-12

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study is classified as reliable without restriction because it followed OECD guideline 404 and followed GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Paraffin wax (CAS # 848301-87-1) (For Petrolatum (Non-carcinogenic Feed-stock))

IUPAC Name:

Paraffin wax (CAS # 848301-87-1) (For Petrolatum (Non-carcinogenic Feed-stock))

Details on test material:

- Name of test material (as cited in study report): SARAWAX 50
- Substance type: paraffin wax
- Physical state: white waxy solid
- Composition of test material, percentage of components: 90 to 94%M N-alkanes, 10 to 6%M iso-alkanes
- Lot/batch No.: 03/3361
- Expiration date of the lot/batch: 2006-09-01
- Stability under test conditions: stable for at least 96 hours in water vehicle
- Storage condition of test material: at room temperature in the dark

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: at least 6 weeks old
- Weight at study initiation: at least 1.0 kilogram
- Housing: individually housed in cages with perforated floors
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16.2 to 23.2°C
- Humidity (%): 49 to 75%
- Air changes (per hr): approximately 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark

IN-LIFE DATES: From: 2003-10-07 To: 2003-10-17

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

other: skin was wetted with 50% v/v ethanol/water solution before application of test material

Controls:

no

Amount / concentration applied:

0.5 grams

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: flank
- % coverage: 2 x 3 centimetres
- Type of wrap if used: metalline patch, mounted on micropore tape, secured with Coban elastic bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): water was used to remove residual test substance
- Time after start of exposure: four hours

SCORING SYSTEM: Draize Method

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 to 72 hours

Score:

ca. 0

Max. score:

4

Reversibility:

fully reversible

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 to 72 hours

Score:

ca. 0

Max. score:

4

Reversibility:

fully reversible

Irritant / corrosive response data:

Slight erythema was observed at 1 hour in the skin areas of all three rabbits but resolved by 24 hours.

Other effects:

None observed

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of the study, paraffin wax is considered not irritating.

Executive summary:

Read across justification

No dermal irritation studies have been reported for petrolatum (non-carcinogenic feed-stock), but data have been reported for paraffin and hydrocarbon waxes, materials similar to constituents of petrolatum (non-carcinogenic feed-stock).

In a primary skin irritation study, the intact skin of three male albino rabbits was exposed to 0.5 milligrams of paraffin wax under semi-occlusive conditions for 4 hours. Animals were observed for 72 hours, and skin irritation or corrosion was scored by the method of Draize at 1, 24, 48, and 72 hours. At the end of the 4 -hour test period, excess paraffin wax was removed with water. Slight erythema was observed at 1 hour in all three animals which was fully reversible by 24 hours. Therefore, under conditions of the study, paraffin wax is considered not irritating.    

           

This study received a Klimisch score of 1 and is classified as reliable without restriction because it is a well-documented study report and closely followed OECD Guideline No. 404.