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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:
17 Dec 1991 - 24 Jan 1992
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions
Justification for type of information:
A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
Cross-reference
Reason / purpose for cross-reference:
read-across: supporting information
Reference
Endpoint:
skin irritation: in vivo
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
17 Dec 1991 - 24 Jan 1992
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions
Justification for type of information:
A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
Reason / purpose for cross-reference:
read-across source
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Score:
0.67
Max. score:
2
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 45 minutes
Score:
0.2
Max. score:
4
Reversibility:
not reversible
Remarks:
within 7 days
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
not reversible
Remarks:
within 7 days
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not reversible
Remarks:
within 7 days
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
not reversible
Remarks:
within 7 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 45 minutes
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
edema score
Basis:
animal: #1, 2, 3, 4, 5, 6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritant / corrosive response data:
Erythema was noted in one animal (score of 1) at the 45 min observation. By the 48 hr observation, all animals showed erythema (max. score 2). At study termination on day 7, 5 animals still showed erythema (score of 1). Desquamation was also noted in 5 animals on day 7. No edema was observed during the experiment.

Table: Skin Irritation Results

Animal

Observation

Hours

Day

0.75

24

48

72

7

JEI656M

Erythema

0

0

1

1

0

Edema

0

0

0

0

0

JEI649M

Erythema

1

0

2

1

1

Edema

0

0

0

0

0

JEI653M

Erythema

0

0

1

1

1

Edema

0

0

0

0

0

JEI661M

Erythema

0

1

1

1

1

Edema

0

0

0

0

0

JEI660M

Erythema

0

1

2

1

1

Edema

0

0

0

0

0

JEI657M

Erythema

0

0

1

1

1

Edema

0

0

0

0

0

Interpretation of results:
other: Category 2 irritant
Remarks:
Criteria used for interpretation of results: other: CLP
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 0.67, 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 data is being read across from the source study that tested hydrocarbons, C6-C7, n-alkanes, isoalkanes, cyclics, <5% n-hexane based on category read across.

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 minutes, 24, 48, and 72 hours after patch removal, and also on day 7. The primary irritation index was 0.67. 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.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Study was terminated on day 7 despite some animals still showing symptoms.
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
hydrocarbons, C6-C7, n-alkanes, isoalkanes, cyclics, < 5% n-hexane
EC Number:
919-389-1
IUPAC Name:
hydrocarbons, C6-C7, n-alkanes, isoalkanes, cyclics, < 5% n-hexane
Details on test material:
- Name of test material (as cited in study report): MRD-91-121
- Physical state: colorless liquid
- Analytical purity: 100%
- Storage condition of test material: room temperature
- Lot/batch No.: I

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hazelton Research Products, Denver, PA
- Age at study initiation: 13 weeks
- Weight at study initiation: 1.95-2.26 kg
- Housing: suspended stainless steel cages with wire mesh
- Diet: Agway Certified Diet, R.C.A. Rabbit, limited on daily basis
- Water (ad libitum): Elizabethtown Water Company
- Acclimation period: 8 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-21
- Humidity (%): 40-60
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: December 17, 1991 To: December 24, 1991

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount applied (volume): 0.5 ml
Duration of treatment / exposure:
4 hours
Observation period:
45 minutes, 24, 48, 78 hours and 7 days after end of exposure
Number of animals:
6 males
Details on study design:
TEST SITE
- Area of exposure: dorsal surface
- Type of wrap if used: Test material was introduced under a gauze patch secured with tape. This was covered by a semi-occlusive dressing.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): reverse osmosis water and 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
Score:
0.67
Max. score:
2
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 45 minutes
Score:
0.2
Max. score:
4
Reversibility:
not reversible
Remarks:
within 7 days
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
not reversible
Remarks:
within 7 days
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not reversible
Remarks:
within 7 days
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
not reversible
Remarks:
within 7 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 45 minutes
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
edema score
Basis:
animal: #1, 2, 3, 4, 5, 6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritant / corrosive response data:
Erythema was noted in one animal (score of 1) at the 45 min observation. By the 48 hr observation, all animals showed erythema (max. score 2). At study termination on day 7, 5 animals still showed erythema (score of 1). Desquamation was also noted in 5 animals on day 7. No edema was observed during the experiment.

Any other information on results incl. tables

Table: Skin Irritation Results

Animal

Observation

Hours

Day

0.75

24

48

72

7

JEI656M

Erythema

0

0

1

1

0

Edema

0

0

0

0

0

JEI649M

Erythema

1

0

2

1

1

Edema

0

0

0

0

0

JEI653M

Erythema

0

0

1

1

1

Edema

0

0

0

0

0

JEI661M

Erythema

0

1

1

1

1

Edema

0

0

0

0

0

JEI660M

Erythema

0

1

2

1

1

Edema

0

0

0

0

0

JEI657M

Erythema

0

0

1

1

1

Edema

0

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
other: Category 2 irritant
Remarks:
Criteria used for interpretation of results: other: CLP
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 0.67, 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 minutes, 24, 48, and 72 hours after patch removal, and also on day 7. The primary irritation index was 0.67. 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.

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