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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
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 OECD Guideline 404.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
A second untreated skin area was not used as a control in the animals
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: low viscosity liquid hydrocarbon
Details on test material:
- Name of test material (as cited in study report): MD-7 or MRD-92-180
- Physical state: amber liquid
- Expiration date of the lot/batch: December 1996
- Storage condition of test material: room temperature
- pH: 6

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: HRP Inc., Denver, Pennsylvania
- Age at study initiation: approximately 14 weeks
- Weight at study initiation: 2.09 to 2.37 kg
- Housing: singly housed in suspended stainles steel and wire mesh with absorbent paper below cages
- Diet (e.g. ad libitum): the amount of feed administered to the animals was limited on a daily basis (limits were not reported in the study report)
- Water (e.g. ad libitum): not reported
- Acclimation period: 8 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.3 to 21.1°C
- Humidity (%): 40 to 60 percent
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark


IN-LIFE DATES: not reported

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): neat
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3 male animals
Details on study design:
TEST SITE
- Area of exposure: clipped back
- % coverage: not reported
- Type of wrap if used: not reported


REMOVAL OF TEST SUBSTANCE
- Washing (if done): not reported
- Time after start of exposure: not reported


SCORING SYSTEM: mean erythema and oedema scores were calculated by the method of Snedecor and Cochran, 1989

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
2.7
Max. score:
4
Reversibility:
fully reversible within: 10 days
Remarks on result:
other: MD-7
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: MD-7
Irritant / corrosive response data:
No corrosivity was observed.
Other effects:
None

Any other information on results incl. tables

No clinical signs were observed during the test period.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Light catalytic cracked distillate is classified as irritating to skin according to EU criteria.
Executive summary:

In a primary dermal irritation study, three male New Zealand White rabbits were exposed to 0.5 mL of light catalytic cracked distillate under semi-occlusive conditions for a 4 -hour exposure period. Animals were observed for 10 days following exposure.

No clinical signs were observed during the test period. Well-defined erythema was observed in one animal, and moderate to severe erythema was observed in two animals at the 1, 24, 48, and 72 hour observation timepoints. Moderate to slight oedema was observed in all animals. Erythema and oedma resolved by day 10, and therefore the study was terminated at that time. Light catalytic cracked distillate is classified as irritating to skin according to EU criteria.

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