Paraffin oils (petroleum), catalytic dewaxed light

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

1980-10-21 to 1980-10-28

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: This study was classified as reliable with restriction. The study is an acceptable, well-documented study report that followed sound scientific principles.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Principles of method if other than guideline:

The method did not strictly follow the guideline but is deemed appropriate as utilized in this report.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

64742-56-9

Cas Number:

64742-56-9

IUPAC Name:

64742-56-9

Constituent 2

Reference substance name:

Solvent dewaxed light paraffinic oil, sufficiently refined, IP 346 < 3%

IUPAC Name:

Solvent dewaxed light paraffinic oil, sufficiently refined, IP 346 < 3%

Test material form:

other: Oily liquid

Details on test material:

- Name of test material (as cited in study report): API 78-9 Solvent dewaxed light paraffinic oil
- CAS number: 64742-56-9
- API Identification number: API 78-9

Molecular weight (if other than submission substance): 322
- Substance type: Other Lubricant Base Oil (Sufficiently Refined, IP 346 < 3%)
- Physical state: Liquid
- Analytical purity: Not reported
- Stability under test conditions: Not reported
- Storage condition of test material: Stable at room temperature
- Other:
Specific gravity 60/60: 0.8490
API gravity: 35.2
Viscosity CS: 11.5 @ 100°F
Viscosity CS: 2.81 @ 210°F
Viscosity SUS: 64.2 @ 100°F
Viscosity SUS: 35.6 @ 210°F
Viscosity Index: 97
Viscosity-gravity constant: 0.807
Pour Point: -3°F
Aniline Point: 200.5 °F
Ramsbottom Carbon:0.03%
Density 20C: 0.8453
Refractive Index ND20:1.4675
UV Absorptivity, 260 nm: 0.500
UV Absorptivity, 290 nm: 0.261
UV Absorptivity, 343 nm: 0.002
Distillation range (°F) 597-751 (5 and 95%)
Initial Boiling Point (°F): 536
Final Boiling Point (°F): 782


- Composition of test material:
ASTMD-2007, Wt. %:
Asphaltenes: 0.0
Saturates: 88.7
Aromatics 11.3
Polar compounds: 0.0

Carbon Distribution (ndm)
% Aromatic carbons: 3
% Naphthenic carbons: 30
% Paraffinic carbons: 67

Sulfur, ppm: 490
Basic Nitrogen, ppm: 20
Total Nitrogen, ppm: 237

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elkhorn Rabbitry (Watsonville, California)
- Age at study initiation: Not reported
- Weight at study initiation: 3.0 - 5.0 Kg
- Fasting period before study: Not reported
- Housing: Individual cage
- Diet (e.g. ad libitum): Purina Rabbit Chow® ad libitum
- Water (e.g. ad libitum): Fresh water ad libitum
- Acclimation period: 14 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: From: 1980-10-02 To: 1980-10-28

Test system

Type of coverage:

occlusive

Preparation of test site:

abraded

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

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

Duration of treatment / exposure:

24 hours

Observation period:

7 days

Number of animals:

3/sex/dose

Details on study design:

TEST SITE
- Area of exposure: Lateral to the midline (back) and 10 cm apart
- % coverage: Not reported
- Type of wrap if used: Plastic wrap secured with one-inch porous tape


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Wiped with guaze sponges
- Time after start of exposure: 24 hours


SCORING SYSTEM: Draize scoring method

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24 h

Score:

1

Max. score:

8

Reversibility:

fully reversible within: 7 days

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:

0.17

Max. score:

8

Reversibility:

fully reversible within: 7 days

Results 4

Irritation parameter:

edema score

Basis:

mean

Time point:

24 h

Score:

0

Max. score:

8

Reversibility:

other: not applicable

Remarks on result:

other: intact and abraded 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:

0

Max. score:

8

Reversibility:

other: not applicable

Remarks on result:

other: intact and abraded skin

Irritant / corrosive response data:

See (Table 1) "Remarks on results including table and figures"

Any other information on results incl. tables

Table 1. Mean Dermal Irritation Scores
Parameter	Exposure time (hours)	Exposure unit (Values^*)
Erythema
Intact Skin	24	1.00
Abraded Skin	72	0.17
Subtotal  =   1.17
Edema
Intact Skin	24	1.00
Abraded Skin	72	0.17
Subtotal  =    1.17
Total      =   2.34
Primary Irritation Score  =   (2.34/4) = ~0.6

^*Average value of animals recorded for dermal irritation in the study.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Edema was not apparent in male or female rabbits at any observation point. Slight erythema (1) was evident in all male and female rabbits at the 24 hour observation point. Very slight erythema (1) was observed in only 1 male rabbit by the 72 hour observation point and no irritation was visible in any test animal by the end of the 7-day observation period. No differences in irritation were observed between intact and abraded skin sites.

API 78-9 when administered dermally was not considered to be irritating to the intact and abraded skin of New Zealand White rabbits

Executive summary:

In a primary dermal irritation study, 6 New Zealand White rabbits (3 male/3 female) were dermally administered 0.5 mL solvent dewaxed light paraffinic oil under occlusive wrap for 24-hours. After the exposure period, the bandages were removed and test sites were wiped with guaze sponges. The animals were observed thereafter and dermal irritation was scored using the method of Draize at 24 hours, 72 hours and on Day 7 post-exposure.

Edema was not apparent in male or female rabbits at any observation point. Very slight erythema (1) was evident in all male and female rabbits at the 24 hour observation point. Very slight erythema (1) was observed in only 1 male rabbit by the 72 hour observation point and no irritation was visible in any test animal by the end of the 7-day observation period. No differences in irritation were observed between intact and abraded skin sites.

Solvent dewaxed light paraffinic oil is not considered to be irritating to the skin of rabbits.

This study is classified as 'reliable with restriction' because although the study is well documented and scientifically acceptable, the results for the 48-hour observation period were not reported as recommended by acceptable guidelines. Adverse systemic effects such as signs of clinical toxicity and body weight were not conducted and/or reported.