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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:
1984-10-13 to 1984-10-16
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable without restriction because it was conducted according to or similar to guideline study OECD TG 404.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
exposure duration was 24 hours instead of 4 hours
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): white mineral oil [F-52-01; ARCOprime 70]
- Molecular formula (if other than submission substance): N/A
- Molecular weight (if other than submission substance): N/A
- Smiles notation (if other than submission substance): N/A
- InChl (if other than submission substance): N/A
- Structural formula attached as image file (if other than submission substance): see Fig. N/A
- Substance type: petroleum hydrocarbons
- Physical state: transparent colourless liquid
- Analytical purity: 100% petroleum hydrocarbons
- Impurities (identity and concentrations): not reported
- Composition of test material, percentage of components: not reported
- Isomers composition: not reported
- Purity test date: not reported
- Lot/batch No.: 769
- Expiration date of the lot/batch: September 1989
- Radiochemical purity (if radiolabelling): N/A
- Specific activity (if radiolabelling): N/A
- Locations of the label (if radiolabelling): N/A
- Expiration date of radiochemical substance (if radiolabelling): N/A
- Stability under test conditions: approximately 5 years
- Storage condition of test material: stored in temperature-monitored room (10 to 27 degrees Celsius)
- Density 0.8433 g/ml
- Flash Point °F: 355

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Alpine Laboratory Rabbits
- Age at study initiation: 8 to 10 weeks
- Weight at study initiation: 2.1 to 2.3 kilograms
- Housing: individually housed in stainless steel cages with screen floors.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 15 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 and 24 degrees Celsius
- Humidity (%): 28 to 57%
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle


IN-LIFE DATES: From: 1984-10-29 To: 1984-10-16

Test system

Type of coverage:
occlusive
Preparation of test site:
other: abraded and intact
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): undiluted


VEHICLE
- Amount(s) applied (volume or weight with unit): N/A
- Concentration (if solution): N/A
- Lot/batch no. (if required): N/A
- Purity: N/A
Duration of treatment / exposure:
24 hours
Observation period:
24 and 72 hours
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 1 inch squares on the lateral sides of the spine
- % coverage: 20%
- Type of wrap if used: gauze pads stabilized with hypoallergenic tape to which a dental dam was applied.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): skin wiped to removed test substance after exposure
- Time after start of exposure: 24 hours


SCORING SYSTEM: Draize technique

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: intact skin
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
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: intact 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:
4
Reversibility:
not specified
Remarks on result:
other: intact skin
Irritant / corrosive response data:
At the 24 and 72 hour observation time points erythema and oedema scores were 0.0 for all sites.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The mean erythema and edema scores of Highly refined base oil under the conditions of this study are both 0. Therefore, the test material is classified as not irritating.
Executive summary:

In a primary dermal irritation study,white rabbits (6 males) were dermally exposed to 0.5 mL of undiluted Highly refined base oil for 24 hours occlusively to 2 abraded and 2 unabraded test sites flanking the spine. Animals were then observed for 24 and 72 hours. Irritation was scored by the method of Draize (1959).

At the 24 and 72 hour observation time points erythema and edema scores were 0.0 for all sites. In this study, Highly refined base oil is not a dermal irritant based on the mean erythema and oedema scores of 0.0. 

This study received a Klimisch score of 1 and is classified as reliable without restriction because it is carried out according to or similar to guideline study OECD TG 404.