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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
Study period:
12 Dec 1989 - 1 Feb 1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Study terminated on day 7, rather than day 14.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): MRD-89-517 from Machelen Chemical Technology Center, Machelen, Belgium
- Physical state: liquid
- Analytical purity: 100 %
- Lot/batch No.: I
- Storage condition of test material: room temperature
- Other: colorless

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hazleton Research Products, Denver, PA
- Age at study initiation: 12 weeks
- Weight at study initiation: 2.0-3.0 kg
- Housing: suspended stainless steel
- Diet: Agway Certified Diet R.C.A. Rabbit, restricted diet
- Water (ad libitum): Elizabethtown Water Company
- Acclimation period: 22 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-23
- Humidity (%): 30-100
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
Duration of treatment / exposure:
4 hours
Observation period:
45, 24, 48, and 72 hours and 7 days after exposure
Number of animals:
4 male/2 female
Details on study design:
TEST SITE
- Area of exposure: dorsal area
- Type of wrap if used: gauze patch secured with tape, loosely held by a semi-occlusive dressing


REMOVAL OF TEST SUBSTANCE
- Washing (if done): reverse osmosis water with paper towels
- Time after start of exposure: 4 hours


SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 and 72 hr observations
Score:
1.42
Reversibility:
not fully reversible within: some animals still exhibited irritation at study termination on day 7
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 45 minutes
Score:
1.5
Max. score:
4
Reversibility:
not reversible
Remarks:
within 7 days
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24, 48, 72 hours
Score:
1.3
Max. score:
4
Reversibility:
not reversible
Remarks:
within 7 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48, 72 hours
Score:
1.7
Max. score:
4
Reversibility:
not reversible
Remarks:
within 7 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48, 72 hours
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
other: 24, 48, 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
other: 24, 48, 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
other: 24, 48, 72 hours
Score:
1.3
Max. score:
4
Reversibility:
not reversible
Remarks:
within 7 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 45 minutes
Score:
0.7
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24, 48, 72 hours
Score:
1
Max. score:
4
Reversibility:
not reversible
Remarks:
within 7 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24, 48, 72 hours
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
animal: #3, 4, 6
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: animal #3, 6: effects occurred after 45 minutes and were fully reversible within 24 hours
Irritation parameter:
edema score
Basis:
animal #5
Time point:
other: 24, 48, 72 hours
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritant / corrosive response data:
All animals exhibited erythema (maximum score of 2), and 4 animals exhibited edema (maximum score of 1) at the 45 min observation. These symptoms were mostly gone by the 72 hr. observation. However, three animals still had symptoms at the study termination on day 7. Desquamation was noted in two animals at the day 7 observation.
Other effects:
One animal had poor food consumption on day 4. Another animals had a small amount of stool also on day 4.

Any other information on results incl. tables

Table: Skin Irritation Results

Animal

Observation

Hours

Day

0.75

24

48

72

7

JEH665M

Erythema

2

1

1

2

2

Edema

1

1

1

1

1

JEH666M

Erythema

2

2

2

1

2

Edema

1

1

1

0

0

JEH658M

Erythema

2

1

1

0

0

Edema

1

0

0

0

0

JEH671M

Erythema

1

1

1

1

0

Edema

0

0

0

0

0

JEH708F

Erythema

1

2

1

0

0

Edema

0

1

0

0

0

JEH712F

Erythema

1

1

2

1

1

Edema

1

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Remarks:
Migrated information
Conclusions:
The test substance, hydrocarbons, C6-C7, n-alkanes, isoalkanes, cyclics, <5% n-hexane, is mildly irritating to skin. Although the primary irritation index was only 1.42, the inflammation had not fully resolved by study termination, therefore it is not known if the effects are reversible. The test substance is a Category 2 irritant under OECD GHS guidelines based on persistant irritation.
Executive summary:

This study examined the skin irritation of the test substance, hydrocarbons, C6-C7, n-alkanes, isoalkanes, cyclics, <5% n-hexane. 0.5 mL of test substance was placed on the clipped skin of 6 rabbits, and covered with a semi-occlusive patch. After 4 hrs of exposure, the test substance was removed. Animals were scored for dermal irritation 45 min, 24 h, 48h, and 72 hrs after patch removal, and also on day 7. The primary irritation index was 1.42. Inflammation had not fully resolved by study termination, therefore it is not known if the effects are reversible. The test substance is a Category 2 irritant under OECD GHS guidelines based on persistant irritation.