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Diss Factsheets

Administrative data

Description of key information

Skin Irritation

Irritating to the skin

Eye Irritation

Not irritating to eyes

 

Respiratory Irritation

No studies were located to indicate that Hydrocarbons, C7, n-alkanes, isoalkanes, cyclics, is a respiratory irritant.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
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: supporting information
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Cunicole de Val de Selle, Prouzel, France
- Weight at study initiation: average weight: 2.4 ± 0.05 kg
- Housing: individually housed; polystyrene cages with feeding bottles and troughs
- Diet: Lapins entretien référence 112 C (U.A.R., Villemoisson-sur-Orge, France); ad libitum during the study
- Water: filtered drinking water; ad libitum during the study
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 50 ± 20 %
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin areas of the test animals served as controls
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL


Duration of treatment / exposure:
4 hours
Observation period:
15 days after application (at 1, 24, 48, 72 hours and thereafter daily)
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: 6 square centimetre
- Type of wrap if used: gauze bandage and compress


SCORING SYSTEM: OECD Draize Scoring System
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.7
Max. score:
4
Reversibility:
other: reversible on day 8, but dryness of the skin
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
other: reversible on day 9, but dryness of the skin
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effect
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effect
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effect
Irritant / corrosive response data:
At 1 hour after exposure, erythema were observed for all three animals and edema for two of three animals.
Interpretation of results:
other: Irritating
Remarks:
Criteria used for interpretation of results: other: GHS (EU, 2007)
Conclusions:
The test substance was irritating to the skin according to the criteria of the EU and the GHS.
Executive summary:

The test substance was irritating to the skin according to the criteria of the EU and the GHS.

Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
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: supporting information
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
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
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
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:
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.

Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
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
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: supporting information
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
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

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
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:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
not reversible
Remarks:
within 7 days
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
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
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
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
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:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not reversible
Remarks:
within 7 days
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
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
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.

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

Interpretation of results:
Category 2 (irritant) based on GHS criteria
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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
18 September 2000 - 26 July 2004
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: supporting information
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Covance Research Products Inc. (formerly HRP), Denver, PA, USA
- Age at study initiation: approximately 15 - 16 weeks
- Weight at study initiation: 2.41 - 2.73 kg
- Housing: single housed during study; suspended stainless steel and wire mesh with absorbent paper below cages
- Diet (e.g. ad libitum): PMI Certified Rabbit Diet 5322; feed was analysed and not contaminated; the animals received new feed each day and the old feed, if any, was discarded. Availability of feed was checked at least once daily for all animals.
- Water (e.g. ad libitum): ad libitum, automatic watering system; water was analysed and not contaminated; availability of water was checked at least once daily for all animals
- Acclimation period: 22 days; animals were examined for viability at least once daily
- Other: animal identification by ear tags and corresponding cage identification


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17.8 - 22.2°C (64 - 72 degrees Fahrenheit)
- Humidity (%): 30 - 70 % relative humidity
- Photoperiod (hrs dark / hrs light): approx. 12 h light (06.00 - 18.00) and 12 h dark (18.00 - 06.00)
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL


Duration of treatment / exposure:
see observation period: The test substance was not washed out.
Observation period (in vivo):
1, 24, 48, 72 hours and 7 days
Number of animals or in vitro replicates:
3 males
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: Draize Standard Eye Irritation Grading Scale (Draize 1959: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, Association of Food and Drug Officials of the US, vol. 49, pp. 2-56.

TOOL USED TO ASSESS SCORE: 2 % sodium fluorescein
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effect
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no effect
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effect
Irritant / corrosive response data:
Ocular instillation of the test substance elicited conjunctival responses in all animals. Iridic and corneal responses were not evident during the study. Conjunctival responses consisted of redness of Grade 2 in all animals and discharge of Grade 1 and Grade 2 for one animal each at the 1 hour evaluation. Discharge was not evident after the 1 hour evaluation but redness of Grade 1 was noted for 2 animals at the 24 and 48 hour evaluations. Redness of Grade 1 also was noted for all animals at 72 hour evaluation. Irritation was not evident at the Day 7 evaluation and the study was terminated.
Other effects:
All animals survived the study termination and were free of clincial signs during the study.
Interpretation of results:
other: Not irritating
Remarks:
Criteria used for interpretation of results: other: GHS (EU, 2007)
Conclusions:
Based on the study design the test substance, hydrocarbons, C7-C9, isoalkanes, is not irritating.
Executive summary:

Based on the study design the test substance, Hydrocarbons, C7-C9, isoalkanes, is not irritating.

Endpoint:
eye irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given
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: supporting information
Principles of method if other than guideline:
according to the Federal Register of the F.D.A. 28 (110), 6.6.1963, para. 191.12. Test for eye irritants
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Strain: albino
- Source: Ranch Rabbits, Crawley, Sussex
- Weight at study initiation: 3 kg
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye served as control
Amount / concentration applied:
0.2 mL
Duration of treatment / exposure:
single application
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
2 males, 2 females
Details on study design:
Undiluted solvent was instilled into the conjunctival sac of the right eye of two male and two female albino rabbits; the untreated left eye served as a control. A visual assessment of irritancy was made half an hour after application and again 1, 2, 3 and 7 days later.
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 0.5 hrs - 7 days
Score:
0
Max. score:
4
Reversibility:
not specified
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4

Conjunctiva redness, chemosis and discharge, Cornea opacity and area, and Iris were scored in 4 animals. In all 4 animals only at timepoint 0.5 hr a very mild irritancy was observed in conjunctiva redness and scored 0 - 1. Thus the overall score can be considered to be 0.

Table: Individual Eye Irritation Scores

Animal

1/2 hr

24 hrs

48 hrs

72 hrs

7 days

1351 Female

Cornea, opacity

0

0

0

0

0

Cornea, area

0

0

0

0

0

Iris

0

0

0

0

0

Conjunctiva, redness

0-1

0

0

0

0

Conjunctiva, chemosis

0

0

0

0

0

Conjunctiva, discharge

0

0

0

0

0

1352 Male

Cornea, opacity

0

0

0

0

0

Cornea, area

0

0

0

0

0

Iris

0

0

0

0

0

Conjunctiva, redness

0-1

0

0

0

0

Conjunctiva, chemosis

0

0

0

0

0

Conjunctiva, discharge

0

0

0

0

0

1422 Female

Cornea, opacity

0

0

0

0

0

Cornea, area

0

0

0

0

0

Iris

0

0

0

0

0

Conjunctiva, redness

0-1

0

0

0

0

Conjunctiva, chemosis

0

0

0

0

0

Conjunctiva, discharge

0

0

0

0

0

1423 Male

Cornea, opacity

0

0

0

0

0

Cornea, area

0

0

0

0

0

Iris

0

0

0

0

0

Conjunctiva, redness

0-1

0

0

0

0

Conjunctiva, chemosis

0

0

0

0

0

Conjunctiva, discharge

0

0

0

0

0

Interpretation of results:
other: not irritating
Remarks:
Criteria used for interpretation of results: other: EU, GHS, 2007
Conclusions:
The purpose of this test was to determine the irritation potential of hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics to rabbit eye. 0.2 mL of test substance was added to the right eye of two male and two female rabbits. The animals were scored for irritation at 0.5 hrs after applications, and also at 1, 2, 3, and 7 days after application. All animals showed conjunctival redness (score of 0-1) at the 0.5 hr observation. No other signs of irritation were noted. The test substance is not irritating to eyes according to OECD GHS guidelines.
Executive summary:

The purpose of this test was to determine the irritation potential of hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics to rabbit eye. 0.2 mL of test substance was added to the right eye of two male and two female rabbits. The animals were scored for irritation at 0.5 hrs after applications, and also at 1, 2, 3, and 7 days after application. All animals showed conjunctival redness (score of 0-1) at the 0.5 hr observation. No other signs of irritation were noted. The test substance is not irritating to eyes according to OECD GHS guidelines.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

There is no data available for Hydrocarbons, C7, n-alkanes, isoalkanes, cyclics. However, data is available for structural analogues, Hydrocarbons, C6 -C7, n-alkanes, isoalkanes, cyclics, <5% hexane, Hydrocarbons, C7 -C9, n-alkanes, isoalkanes, cyclics and Hydrocarbons, C7 -C9, isoalkanes and are presented in the dossier. This data is read across to Hydrocarbons, C7, n-alkanes, isoalkanes, cyclics based on analogue read across and a discussion and report on the read across strategy is provided as an attachment in IUCLID Section 13.

Skin Irritation

Hydrocarbons, C7 -C9, isoalkanes

In a key study (Total, 2000), the skin irritation potential of Hydrocarbons C7-C9, isoalkanes was determined according to OECD 404 (Total Solvants, 2000a). The test substance was applied to the intact skin of rabbits for 4 hours under semi occlusive conditions. After removal of the test substance, no edema, but well-defined to moderate erythema were noted in all three animals. Irritating effects were reversible within 9 days. Under the test conditions, the test substance was irritating to the skin.

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

A key study (Exxon, 1992) 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.

 

In another key study (Exxon, 1990) 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.

In a supporting study (Shell, 1987), The skin irritation of hydrocarbons, C6-C7, n-alkanes, isoalkanes, cyclics, <5% n-hexane was examined by the adminstration of 0.5 mL of test substance to the clipped skin of 6 rabbits, and covered with a semi-occlusive patch. After 4 hours the wrapping and patch was removed and the test site washed with water and gently dried. The substance caused minimal erythema when the application patches were removed. At 72 hours half the rabbits were still affected. All skin effects in all treated animals had cleared by 7 days.

Ocular Irritation

 

Hydrocarbons, C7-C9, isoalkanes

In a key study (Exxon, 2004), the eye irritation potential of the hydrocarbons, C7-C9, isoalkanes was determined by instillation of 0.1 mL of the test material into the conjunctival sac of 3 rabbits. Ocular reactions were examined and scored 1, 24, 48, 72 hours after application. At the 1 hour evaluation, conjunctival redness (grade 2) was observed in all animals. Conjunctival redness (grade 0-1) was also noted in all animals at the 72 hour evaluation. All redness was reversible within 7 days. No corneal opacity, iritis or conjunctival chemosis was noted in any of the 3 rabbits.

In two supporting studies (Exxon, 1997a, 1997b), eye irritation studies performed according to OECD 404 showed that no ocular irritation in any animal at any time point could be observed for the compounds ISOPAR E and ISOPAR C.The test substance was administered into the lower conjunctival sac of the right eye. The upper and lower lids were gently held togehter for approximately 1 second to prevent loss of test substance. The contralateral eye served as the control. Animals were examined for viability twice daily. Body weights were recorded on Day 0. Observations were also made for unusual effects such as pannus, blistering of the conjunctivae, ulceration, or other effects indicative of a corrosive action. Under the design of this study the test substance, hydrocarbons, C7 -C9, isoalkanes is not irritating.

In another supporting study (Exxon, 1962c), the eye irritation of hydrocarbons, C7 -C9, isoalkanes was determined by adminstration of 0.1 mL of the test material into the left eyes of 6 rabbits.At one hour after administration, four of the treated eyes showed slight erythema which completely subsided by the four-hour observation. The remaining two animals showed slight or moderate erythema, slight edema, and slight discharge. The treated eye of one of these animals appeared normal at 24 hours, while the remaining animal showed slight erythema and a discharge at this time. At 48 hours this animal showed only slight erythema and this was fully reversible within 72 hours after administration. The terminal fluorescein examination revealed no evidence of corneal damage in any of the treated eyes. Under the design of this study the test substance, hydrocarbons, C7 -C9, isoalkanes, is not irritating.

Hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics

In a key study (Shell, 1977), the eye irritation potential of hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics was determined by instillation of 0.2 mL of the test material into the conjunctival sac of 4 rabbits. A visual assessment of irritancy was made 30 min, 24, 48, 72 hours and 7 days after application. At 30 min after application, a very mild irritancy was observed in mild conjunctival redness (grade 0-1) in all animals. All redness was reversible within 24 hours. No corneal opacity, iritis, conjunctival chemosis, or discharge was noted in any of the 4 rabbits.

Respiratory Irritation

No studies were located to indicate that Hydrocarbons, C7, n-alkanes, isoalkanes, cyclics, is a respiratory irritant. 

Justification for classification or non-classification

Skin Irritation:

Based on available read across data, skin irritating effects are expected from the exposure to Hydrocarbons, C7, n-alkanes, isoalkanes, cyclics. Therefore the substance is considered as a skin irritant and classified as a Category 2 skin irritant under the new Regulation (EC) 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP).

Eye Irritation:

Based on available read across data, Hydrocarbons, C7, n-alkanes, isoalkanes, cyclics does not meet the criteria for classification as an ocular irritant under the new Regulation (EC) 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP).

Respiratory Irritation:

There are no studies that warrant classification as a respiratory irritant under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).