Registration Dossier
Registration Dossier
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EC number: 921-024-6 | 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 -C7, n-alkanes, isoalkanes, cyclics, <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:
- 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
- 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
- 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.
- 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
- 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:
- 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 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:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 27 Apr 1987 - 08 May 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Sittingbourne Research Centre Breeding unit
- Age at study initiation: 3-6 months
- Weight at study initiation: 3834-4988 g
- Housing: singly housed in hanging, stainless steel cages with all-mesh floors and tops and half mesh fronts (67x43x45 cm).
- Diet (ad libitum): Standard rabbit diet, S. Q. C.
- Water (ad libitum): filtered but untreated from the public supply
- Acclimation period: at least two weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-19
- Photoperiod: Lighting (fluorescent tube) was automatically switched on for the day (0600 to 1800 hours GMT) and off for the night (1800 to 0600 hours GMT). - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 30 minutes, 24, 48, 72 hours and 7 days
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 2 cm x 2 cm
- Type of wrap if used: The patch and surrounding skin were covered by a single layer of gauze and held in place by means of an elastic adhesive bandage.
REMOVAL OF TEST SUBSTANCE
- Washing: After 4 hours the wrapping and patch was removed and the test site washed with water and gently dried.
SCORING SYSTEM: The site was examined and scored for erythema and oedema on a graded scale of 0 to 4. - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 30 minutes
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- 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:
- 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:
- 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:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 30 minutes
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal: #1, 2, 3, 4, 5, 6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- SBP 60/95 LNH 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.
- Interpretation of results:
- other: Not irritating
- Remarks:
- Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Hydrocarbons, C6-C7, n-alkanes, isoalkanes, cyclics, < 5% n-hexane 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.
- Executive summary:
Hydrocarbons, C6-C7, n-alkanes, isoalkanes, cyclics, < 5% n-hexane 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.
Referenceopen allclose all
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 |
|
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 |
|
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
- 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
- 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
- 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.
Reference
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 is substance specific data available for Hydrocarbons, C6 -C7, n-alkanes, isoalkanes, cyclics, <5% n-hexane. Additionally, data is available for structural analogue, Hydrocarbons, C7 -C9, n-alkanes, isoalkanes, cyclics and is presented in the dossier. This data is read across to Hydrocarbons, C6 -C7, n-alkanes, isoalkanes, cyclics, <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 -7, n-alkanes, isoalkanes, cyclics, <5% n-hexane
A 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.
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), Hydrocarbons, C6-C7, n-alkanes, isoalkanes, cyclics, <5% n-hexane 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.
Eye Irritation
Hydrocarbons, C7 -C9, n-alkanes, isoalkanes, cyclics
The irritation potential of hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics to rabbit eye was determined in a key eye irritation test (Shell, 1977). 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.
Respiratory Irritation
No studies were located to indicate that Hydrocarbons, C6 -C7, n-alkanes, isoalkanes, cyclics, <5% n-hexane, is a respiratory irritant.
Justification for classification or non-classification
Skin Irritation:
Based on available substance specific data, skin irritating effects are expected from the exposure to Hydrocarbons, C6 -C7, n-alkanes, isoalkanes, cyclics, <5% n-hexane. Therefore the substance is considered as a skin irritant and classified as a Category 2 skin irritant.
Eye Irritation:
Based on available read across data, Hydrocarbons, C6 -C7, n-alkanes, isoalkanes, cyclics, <5% n-hexane 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)
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
