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Toxicological information

Skin irritation / corrosion

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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: This study is classified as reliable without restriction because it was conducted similar to guideline study OECD TG 404.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
24hr occluded exposure raher than 4 hr semi-occluded. The second area on each rabbit was abraded and test material applied, rather than serving as an unabraded control area.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: semi-solid
Details on test material:
- Name of test material (as cited in study report): 64741-56-6, API 81-13
- Substance type: Bitumen
- Physical state: Semi-solid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dutchland Laboratories, Inc., Denver, PA
- Age at study initiation: Approximately 14 weeks
- Weight at study initiation: 2959 g (average)
- Housing: Individually in screen bottom cages
- Diet (e.g. ad libitum): Ad libitum, continuous access to Purina certified rabbit chow
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: At least 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 21
- Humidity (%): 36 to 68
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Remarks:
Material was warmed slightly before application
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL test material (as submitted)
Duration of treatment / exposure:
24 hour exposure
Observation period:
24, 72 hours, 96 hours, 7 and 14 days
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: back and flanks
- Type of wrap if used: 2.5x2.5 cm gauze patch, secured with paper tape and overwrapped with saran wrap and elastoplast tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Wiped as thoroughly as possible without irritating the skin
- Time after start of exposure: 24 hours

SCORING SYSTEM: Draize, 1959

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
0.2
Max. score:
4
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
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
4
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:
0.2
Max. score:
4
Remarks on result:
other: intact skin

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Not irritating under EU (EC 1272/2008). Criteria used for interpretation of results: EU
Conclusions:
The mean erythema and oedema scores for 24 and 72 hours were both 0.1. Under the conditions of this study, Vacuum Residuum was determined to be not irritating to rabbit skin.
Executive summary:

In a primary dermal irritation study, 6 male New Zealand White Rabbits were dermally exposed to 0.5 mL of Vacuum Residuum for 24 hours, under occlusive dressing, to clipped back areas. Animals then were observed for 14 days. Irritation was scored by the method of Draize, 1959.

 

The mean erythema and oedema scores for 24 and 72 hours were both 0.1. By day 14, oedema had resolved, but the mean erythema score was 0.8 on day 14. In this study, Vacuum Residuum is not a dermal irritant based on minimal erythema and oedema scores.

 

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