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Toxicological information

Skin irritation / corrosion

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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

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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 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

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
1
Max. score:
8
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
0.17
Max. score:
8
Reversibility:
fully reversible within: 7 days
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
Irritation parameter:
edema score
Basis:
mean
Time point:
48 h
Remarks on result:
not measured/tested
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.