Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Endpoint summary
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 C6 -C10 (even numbered), n-alkanes, isoalkanes, >5% n-hexane is a respiratory irritant.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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.
- 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.
- 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.
- 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.
Referenceopen allclose all
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 |
|
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 |
|
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- 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
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 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.
Referenceopen allclose all
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 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
There are no skin or eye irritation data available on the Hydrocarbons, C6-C10 (even numbered), n-alkanes, isoalkanes, >5% n-hexane. However, there are reliable data available for structural analogues Hydrocarbons, C6-C7, n-alkanes, isoalkanes, cyclics, <5% n-alkanes, Hydrocarbons, C7-C9, isoalkanes, and Hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics and presented in the dossier. This data is read across to Hydrocarbons, C6-C10 (even numbered), n-alkanes, isoalkanes, >5% n-hexane 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, C6 -C7, n-alkanes, isoalkanes, cyclics, <5% n-hexane
Two studies of ExxonMobil (1990a and 1992a) showed irritating effects to the skin of rabbits based on persistant irritation at study termination. ExxonMobil (1990a) examined the skin irritation of the hydrocarbons, C6-C7, n-alkanes, isoalkanes, cyclics, < 5% n-hexane, conducted similar to OECD 404. 0.5 mL of test substance was applied on the clipped skin of 6 rabbits, and covered with a semi-occlusive patch. After 4 hours of exposure, the test substance was removed. Animals were scored for dermal irritation 45 min, 24, 48, 72 hours and 7 days after patch removal. All animals exhibited very slight to well-defined erythema. In 3 of 6 rabbits, very slight edema were observed. These symptoms were mostly reversible within 7 days. However, three animals still showed irritating symptoms at the study termination. Desquamation was noted in two animals at day 7 of the observation period.
In a subsequent study of ExxonMobil (1992a), the skin irritation potential of the test substance was determined according to the study design of ExxonMobil (1990a). No edema were noted, but all animals exhibited very slight to well-defined erythema. In 5 of 6 rabbits, these symptoms were not reversible within the observation period of 7 days. Desquamation was also noted in 5 of 6 animals at the study termination.The test substance is skin irritating based on persistant irritation at the end of the observation period of 7 days. An observation period of 14 days was not considered in the study.
In contrast, the skin irritation potential of hydrocarbons, C6-C7, n-alkanes, isoalkanes, cyclics, < 5% n-hexane was determined according to OECD 404 (Shell, 1987a) yielding a negative result. The test substance was applied to the intact skin of rabbits for 4 hours under semiocclusive conditions. After removal of the test substance, no edema, but very slight erythema were noted. At 72 hours 3 of 6 rabbits were still affected. All skin effects in all treated animals had cleared by 7 days.
Hydrocarbons, C7-C9, isoalkanes
The skin irritation potential of the test substance (Hydrocarbons C7-C9, isoalkanes, <2% aromatics) was determined according to OECD 404 (Total Solvants, 2000). The test substance was applied to the intact skin of rabbits for 4 hours under semiocclusive 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.
Eye Irritation
Hydrocarbons, C7-C9, isoalkanes
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 (ExxonMobil, 2004). 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. Two further 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 (both studies from ExxonMobil, 1997a,b). In another study of ExxonMobil (1962c) conducted similar to OECD 405, at 1 hour after administration, 4 of 6 animals showed slight erythema which completely subsided by the 4 hour observation. The remaining 2 animals showed slight or moderate erythema, slight edema, and slight discharge. These irritating effects were fully reversible within 72 hours after administration.Under the test conditions, the test substance was not irritating to the eyes.
Hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics
The eye irritation potential of the 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 (Shell, 1977b). 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 as 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 C6-C10 (even numbered), n-alkanes, isoalkanes, >5% n-hexane, isoalkanes is a respiratory irritant.
Justification for classification or non-classification
Skin Irritation:
Based on available substance specific data, Hydrocarbons C6-C10 (even numbered), n-alkanes, isoalkanes, >5% n-hexane meets the criteria for classification as a skin irritant (Skin Irrit. 2; H315; causes skin irritation) under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).
Ocular Irritation:
Based on available substance specifc data, Hydrocarbons C6-C10 (even numbered), n-alkanes, isoalkanes, >5% n-hexane does not meet the criteria for classification as an ocular irritant under the new Regulation (EC) 1272/2008 on classification, labeling 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).
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