Naphtha (petroleum), light steam-cracked arom.

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliant, guideline study, available as unpublished report, minor restrictions in reporting but otherwise adequate for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OTS 798.4470 (Acute Dermal Irritation)

Deviations:

yes

Remarks:

occlusive dressing used

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Naphtha (petroleum), steam-cracked middle arom.

EC Number:

271-138-9

EC Name:

Naphtha (petroleum), steam-cracked middle arom.

Cas Number:

68516-20-1

IUPAC Name:

Naphtha (petroleum), steam-cracked middle arom.

Test material form:

liquid

Details on test material:

- Name of test material (as cited in study report): E000144700
- Physical state: Clear, pale yellow to yellow liquid, gasoline-like naphtha odour
- Analytical purity: Not reported
- Lot/batch No.: Not reported
- Stability under test conditions: Stable
- Storage condition of test material: 50-80°F

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Sterling Rabbitry, Wellsville, Utah, USA.
- Age at study initiation: Young adult
- Weight at study initiation: 2.0-4.0 kg
- Housing: Individually in stainless steel, wire mesh bottom cages.
- Diet: Fresh certified Agway rabbit feed ad libitum
- Water: Fresh potable water ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature: 61-71°F
- Humidity: 40-60%
- Air changes: At least 10 per hr
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: From: 5 February 1990 To: 8 February 1990

Test system

Type of coverage:

occlusive

Preparation of test site:

other: clipped

Vehicle:

unchanged (no vehicle)

Controls:

other:

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:

4 h

Observation period:

72 h

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: dorsal area (approximately 1 square inch)
- Type of wrap if used: gauze patch taped with hypoallergenic tape and wrapped with an impervious, non-reactive rubberised material and taped in place.

SCORING SYSTEM: Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

2.8

Max. score:

4

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other: scores at all time points

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

3.2

Max. score:

4

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other: scores at all time points

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

E000144700 is irritating but not corrosive to the skin.

Executive summary:

The primary dermal irritation of E000144700 (CAS 68516-20-1) was investigated in a group of 6 albino rabbits. 0.5 mL of neat test substance was applied to approximately 1 square inch of shaved dorsal skin and retained in contact for 4 hours under an occlusive dressing. Erythema and oedema was seen in all six animals from 1 hour until 72 hours after removal of the dressing. Mean erythema and oedema scores over 24, 48 and 72 hours were greater than 2.

E000144700 (CAS 68516-20-1) is irritating to rabbit skin and warrants classification Category 2, H315 under GHS/CLP.