Hydrocarbons, C6-C7, n-alkanes, isoalkanes, cyclics, <5% n-hexane

Skin irritation / corrosion

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

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

Test material information

Constituent 1

Reference substance name:

Hydrocarbons, C6-C7, n-alkanes, isoalkanes, cyclics, <5% n-hexane

EC Number:

921-024-6

Molecular formula:

none available - not a single isomer - see remarks

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-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 or test system 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

Results

Results 1

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

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 45 minutes

Score:

1.5

Max. score:

4

Reversibility:

not reversible

Remarks:

within 7 days

Results 3

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.3

Max. score:

4

Reversibility:

not reversible

Remarks:

within 7 days

Results 4

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.7

Max. score:

4

Reversibility:

not reversible

Remarks:

within 7 days

Results 5

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 6

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 7

Irritation parameter:

erythema score

Basis:

animal #5

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 8

Irritation parameter:

erythema score

Basis:

animal #6

Time point:

24/48/72 h

Score:

1.3

Max. score:

4

Reversibility:

not reversible

Remarks:

within 7 days

Results 9

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 45 minutes

Score:

0.7

Max. score:

4

Reversibility:

not fully reversible within: 7 days

Results 10

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

not reversible

Remarks:

within 7 days

Results 11

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 12

Irritation parameter:

edema score

Basis:

animal: #3, 4, 6

Time point:

24/48/72 h

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

Results 13

Irritation parameter:

edema score

Basis:

animal #5

Time point:

24/48/72 h

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.