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Diss Factsheets

Administrative data

Description of key information

Skin Irritation

irritating to the skin

Ocular Irritation

not ocular irritants 

Respiratory Irritation

No studies were located to indicate that Hydrocarbons, C10, aromatics, <1% naphthalene is a respiratory irritant.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
29/09/1992-21/10/1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study according to EEC Directive 84/449.
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:
other: Directive 67/548/EEC (OECD TG 404)
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Froxfield Farms U.K. Ltd
- Age at study initiation: 3 to 5 months
- Weight at study initiation: 3.02-3.54 kg
- Housing: singly in hanging stainless steel cages with perforated or wire-mesh flooring, animals identified by cage-labels and ear-tags
- Diet (e.g. ad libitum): Standard Rabbit Diet, S.Q.C., Special Diets Services Ltd.
- Water (e.g. ad libitum): tap water


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15-20
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): neat


Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48, and 72 hrs
7, 14, 21 days
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: dorsal skin
- Type of wrap if used: 6 cm² lint patch covered with a larger gauze patch


REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water
- Time after start of exposure: 4 hrs


SCORING SYSTEM: Draize
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
1.9
Max. score:
2
Reversibility:
fully reversible within: 21 days
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
Desquamation was noted in all animals on day 7. By day 21 all symptoms were fully reversed.

Dermal Scores for Each Animal

  Dermal Response  1 hr  24 hr  48 hr  72 hr  7 days  10 days  14 days 
TT017 M  Erythema  1  2  2  2  1  1  0 
  Edema  0  0  0  0  0  0  0 
TT019 M  Erythema  1  2  2  2  1  0  0 
  Edema  0  0  0  0  0c  0  0 
TT021 M  Erythema  1  2  2  1  1  0  0 
  Edema  0  0  0  0  0d  0  0 
TT036 F  Erythema 1  2  2  2  0  0  0 
  Edema  0  0  0  0  0  0c  0 
TT038 F  Erythema  1  2  2  1  1  0  0 
  Edema  0  0  0  0  0  0c  0 
 TT043 F Erythema  1 2  2  2  1  0  0 
  Edema  0  0  0  0  0c  0b  0

b - slight desquamation

c - desquamation

d - reduced pliability

Summary of other skin irritation studies

End Point Study Reference  
REACH requirement IUCLID Section Study Name Data Waiving Waiving Justification Species Study Result Type Test Guideline/Qualifier Test Guideline/Guideline Test Guideline/Deviations Reliability Rational For Reliability GLP Compliance Test Materials/Identity Study Result Reference Type Reference Author Reference Year Reference Title Bibliographic Source Testing Laboratory Reference Report No. Owner Company Company Study No. Report Date Data access
8.1 Skin Irritation or Corrosion 7.3.1  Primary Dermal Irritation Study in the Rabbit Rabbit experimental result equivalent or similar to  OECD Guideline 404 Exposure for 24 hrs, rather than 4 hrs.  2 In general agreement with OECD test guideline 404.  No data MRD-ECH-80-14 not classifiable  study report ANON 1980 Primary Dermal Irritation Study in the Rabbit HSPA0139 Bio/dynamics Inc. 6301-80 ExxonMobil Petroleum & Chemical BVBA 80MRL23 31/12/1980 yes 
8.1 Skin Irritation or Corrosion 7.3.1  Primary Skin Irritation - Rabbit Rabbit experimental result equivalent or similar to  OECD Guideline 404 Exposure for 24 hrs, rather than 4 hrs, no sex data available, 12 rabbits used, and no data reported for 48 hr time point. 2 Uses Draize Method which is in general agreement with OECD test guideline 404.  No data MRD-61-14 not classifiable  study report ANON 1963 Primary Skin Irritation - Rabbit HSPA0143 Hazleton Laboratories, Inc.  29890 ExxonMobil Petroleum & Chemical BVBA 63MRL2 yes 
8.1 Skin Irritation or Corrosion 7.3.1  Primary Dermal Irritation Study in the Rabbit  Rabbit experimental result equivalent or similar to  OECD Guideline 404 Study ended on day 7, when there was still unresolved delayed erythema. 2 In general agreement with OECD test guideline 404.  No data MRD-83-208 not irritating study report ANON 1984 Primary Dermal Irritation Study in the Rabbit HSPA0144 Exxon Biomedical Science, Inc.  320804 ExxonMobil Petroleum & Chemical BVBA 84MRL88 13/04/1984 yes 
8.1 Skin Irritation or Corrosion 7.3.1  Primary Dermal Irritation Study in the Rabbit Rabbit experimental result equivalent or similar to  OECD Guideline 404 No 2 In general agreement with OECD test guideline 404 - GLP.  Yes MRD-85-734 irritating study report ANON 1986 Primary Dermal Irritation Study in the Rabbit HSPA0145 Exxon Biomedical Science, Inc.  273404 ExxonMobil Petroleum & Chemical BVBA 86MRL60 09/04/1986 yes 
8.1 Skin Irritation or Corrosion 7.3.1  Primary Dermal Irritation Study in the Rabbit  Rabbit experimental result equivalent or similar to  OECD Guideline 404 No 1 In agreement with OECD test guideline 404 - GLP.  Yes MRD-89-522 not irritating study report ANON 1990 Primary Dermal Irritation Study in the Rabbit  HSPA0146 Exxon Biomedical Science, Inc.  252204 ExxonMobil Petroleum & Chemical BVBA 90MRL97 02/02/1990 yes 
8.1 Skin Irritation or Corrosion 7.3.1  Primary Dermal Irritation Study in the Rabbit Rabbit experimental result equivalent or similar to  OECD Guideline 404 Exposure for 24 hrs, rather than 4 hrs.  2 In general agreement with OECD test guideline 404.  No data MRD-ECH-80-14 not classifiable  study report ANON 1980 Primary Dermal Irritation Study in the Rabbit HSPA0138 Bio/dynamics Inc. 6301-80 ExxonMobil Petroleum & Chemical BVBA 80MRL20 11/07/1980 yes 
8.1 Skin Irritation or Corrosion 7.3.1  Primary Irritation of the Skin Rabbit experimental result equivalent or similar to  OECD Guideline 404 Exposure for 24 hrs, rather than 4 hrs.  2 Uses Draize Method which is in general agreement with OECD test guideline 404. Summary of study only. No data Shellsol A moderate irritant study report Coombs, AD, Blair, D, Doak, SM, Carter, BI 1977 The Acute Toxicity of Shellsol A HSPA0685 Sittingbourne Research Centre M(T)-1-77 Shell Chemicals Europe BV June, 1977 yes 
Interpretation of results:
other: not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Hydrocarbons, C9, aromatics is a mild skin irritant.
Executive summary:

This study examined the irritation/corrosion of Hydrocarbons, C9, aromatics to rabbit skin. 0.5 ml of test substance was applied to the clipped dorsal skin of 3 male and 3 female rabbits for 4 hrs. Animals were then examined at 1, 24, 48, and 72 hrs, and 7, 14, and 21 days after the end of exposure and scored using the Draize method for signs of erythema, edema, and corrosion. Mean erythema score (24, 48, and 72 hrs) was 1.9, and the mean edema score (24, 48, and 72 hrs) was 0.0. Desquamation was noted in all animals on day 7. By day 21 all symptoms were fully reversed. Hydrocarbons, C9, aromatics, is therefore not corrosive and only mildly irritating to skin. According to EU GHS guidelines, Hydrocarbons, C9, aromatics, would be not be classified as a skin irritant.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1990/05/02-1990/05/15
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: According to OECD Guideline 405. GLP
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 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hazelton Research Products, Inc.
- Sex: female (6)
- Age at study initiation: 14 weeks
- Weight at study initiation: 2.48-2.75 kg
- Housing: Individually
- Diet (e.g. ad libitum): Agway Certified Diet R.C.A. Rabbit (pellets), restricted with new food each day
- Water (e.g. ad libitum): Automatic watering system, ad libitum
- Acclimation period: 15 days


ENVIRONMENTAL CONDITIONS
- Temperature (°F): 65-70
- Humidity (%): 40-60
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
other: contralateral eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): neat

Duration of treatment / exposure:
Test material was introduced into the lower conjunctival sac of the right eye of each animal, the upper and lower lids were gently held together for one second prior to releasing to prevent loss of material.
Observation period (in vivo):
1, 4, 24, 48, and 72 hrs post instillation and once per day on days 4 and 7.
Number of animals or in vitro replicates:
Female (6)
Details on study design:
SCORING SYSTEM: Draize scale for ocular irritation

Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
mean
Time point:
other: 1 hr
Score:
1.7
Max. score:
2
Reversibility:
fully reversible within: 72 hrs
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
mean
Time point:
24 h
Score:
0.5
Max. score:
1
Reversibility:
fully reversible within: 72 hrs
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
mean
Time point:
48 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 72 hrs
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1 hr
Score:
1.33
Reversibility:
fully reversible within: 48 hrs
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24 h
Score:
0.17
Max. score:
1
Reversibility:
fully reversible within: 48 hrs
Irritation parameter:
chemosis score
Basis:
mean
Time point:
48 h
Score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
72 h
Score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1-72 hrs
Score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1-72 hrs
Score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: Mean 24, 48, and 72-hour scores not specified
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: Mean 24, 48, and 72-hour scores not specified
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: Mean 24, 48, and 72-hour scores not specified
Irritant / corrosive response data:
Redness was noted for all animals at the 1 hr observation point, for 3 animals at the 24 hr observation point, and for two animals at the 48 hr observation point. Chemosis was noted for all animals at the 1 hr observation and for 1 animal at the 24 hr observation point. Only one animal was noted in having discharge at the 1 hr time point. All animals were free of any occular irritation after the 48 hr observation. The maximum Draize score was 8 at the 1 hr time point.

Summary of other eye irritation studies:

Chemical Name: Hydrocarbons, C9, aromatics  
Reference Substance:          
CAS Number: 64742-95-6        
EC Number: 265-199-0        
SMILES:          
End Point Study Reference  
REACH requirement IUCLID Section Study Name Data Waiving Waiving Justification Species Study Result Type Test Guideline/Qualifier Test Guideline/Guideline Test Guideline/Deviations Reliability Rational For Reliability GLP Compliance Test Materials/Identity Study Result Reference Type Reference Author Reference Year Reference Title Bibliographic Source Testing Laboratory Reference Report No. Owner Company Company Study No. Report Date Data access
8.2 Eye Irritation 7.3.2 Draize Eye Irritation Studies - Rabbits  Rabbit Experimental result Equivalent or similar to  OECD guideline 405 Eyes of some animals were irrigated 2 Acceptable, well-documented study report in general agreement with OECD guideline 405. Not performed according to GLP. No     MRD-61-14 not irritating Study report ANON 1961 Draize Eye Irritation Studies - Rabbits HSPA0147 Hazleton Laboratories ExxonMobil Petroleum & Chemical BVBA 61MRL7 yes
8.2 Eye Irritation 7.3.2 Ocular Irritation Study in the Rabbit Rabbit Experimental result Equivalent or similar to  OECD guideline 405 Failed to continue study to 21 days when symptoms were still present at 72 hrs.  2 Similar to OECD guideline 405. yes MRD-90-720 not classifiable Study report ANON 1990 Ocular Irritation Study in the Rabbit HSPA0150 Exxon Biomedical Sciences, Inc.  172013 ExxonMobil Petroleum & Chemical BVBA 90MRL166 12/06/1990 yes
8.2 Eye Irritation 7.3.2 Eye Irritation Study in Rabbits Rabbit Experimental result Equivalent or similar to  OECD guideline 405 No 2 Similar to OECD guideline 405. No data MRD-ECH-80-14 not irritating Study report ANON 1980 Eye Irritation Study in Rabbits HSPA0148 Bio/dynamics Inc. 29641 ExxonMobil Petroleum & Chemical BVBA 80MRL16 11/07/1980 yes
8.2 Eye Irritation 7.3.2 Eye Irritation  Rabbit Experimental result According to Federal Register, 28, (110), 6.6.1963. para 191.12. Test for eye irritation. No 2 Summary only of study. No data Shellsol A not irritating Study report Coombs, AD, Blair, D, Doak, SM, Carter, BI 1977 The Acute Toxicity of Shellsol A HSPA0686 Sittingbourne Research Centre M(T)-1-77 Shell Chemicals Europe BV June, 1977 yes
Interpretation of results:
other: Not irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Based on the individual and mean scores of ocular irritations, test substance would not be considered an ocular irritant under either EU GHS guidelines or under the EU requirements for dangerous substances and preparations guidelines.
Executive summary:

This study was conducted to determine the potential of the substance to cause irritation to the eye in a rabbit model system. Six rabbits were instilled with 0.1 ml of MRD-89 -522, neat. Ocular examinations occurred at 1, 4, 24, 48, and 72 hrs, and days 4 and 7 post instillation. Ocular damage was assessed and scored according to the Draize eye test. All animals survived the exposure. Maximum observed Draize score was 8. Irritation subsided as the study progressed and all animals were clear of ocular irritation after the 48 hr observation. Based on the individual and mean scores, test substance should not be considered an ocular irritant under either EU GHS guidelines or under the EU requirements for dangerous substances and preparations 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, C10, aromatics, <1% naphthalene. However, data is available for a structural analogue, Hydrocarbons, C9, aromatics and presented in the dossier. This data is read across to 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, C9, aromatics

A key skin irritation study (Shell, 1993) examined the irritation/corrosion of Hydrocarbons, C9, aromatics to rabbit skin. 0.5 mL of test substance was applied to the clipped dorsal skin of 3 male and 3 female rabbits for 4 hrs. Animals were then examined at 1, 24, 48, and 72 hrs, and 7, 14, and 21 days after the end of exposure and scored using the Draize method for signs of erythema, edema, and corrosion. Mean erythema score (24, 48, and 72 hrs) was 1.9, and the mean edema score (24, 48, and 72 hrs) was 0.0. Desquamation was noted in all animals on day 7. By day 21 all symptoms were fully reversed. Hydrocarbons, C9, aromatics, is therefore not corrosive and only mildly irritating to skin. According to EU GHS guidelines, Hydrocarbons, C9, aromatics, would be not be classified as a skin irritant.

 

In a supporting study (ExxonMobil, 2004a), 3 male rabbits were subjected to a 4 hr dermal (shaved) exposure of 0.5 mL of the test material (Hydrocarbons, C9, aromatics) under a gauze pad and a compression wrap via a semi-occluded patch. Dermal responses were evaluated at 1, 24, 48, and 72 hrs post-dosing and on Days 7, 10, and 14 according to the Draize method of scoring. Animals exhibited maximum erythema (Grade 2 and 3) at the 24 hr observation point. Edema was most severe at the 1 hr observation point for all animals (Grade 2). Effects gradually lessened until there were minimal signs of edema or erythema at Day 14. By study termination, all animals were free of adverse clinical signs.

 

In a second supporting study (ExxonMobil, 2004b), 3 rabbits were subjected to a 4 h dermal (shaved) exposure of 0.5 ml of the test material (Hydrocarbons, C9, aromatics) via a semi-occluded patch. Dermal responses were evaluated at 1, 24, 48, and 72 hrs post-dosing and on Days 7, 10, and 14 according to the Draize method of scoring. All animals exhibited maximal erythema and edema at the 24 h observation point with effects gradually lessening until there were no signs of edema or erythema at Day 14. By study termination, all animals were free of adverse clinical signs.

 

In another supporting study (ExxonMobil, 2004c), 3 male rabbits were subjected to a 4 hr dermal (shaved) exposure of 0.5 mL of the test material (Hydrocarbons, C9, aromatics) under a gauze pad via a semi-occluded patch. Dermal responses were evaluated at 1, 24, 48, and 72 hrs post-dosing and on days 7, 10, and 14 according to the Draize method of scoring. Animals exhibited maximum erythema, grade 4 at the 24 hr observation point and the erythema remained in all animals through the 72 hr time period. Edema was noted at the 24 hr to 10 day time points, with severity fluctuating from mild (grade 1, 24 hrs) to more severe (grade 3, day 7). Effects gradually lessened until all animals were free of adverse clinical signs at day 14.

Hydrocarbons, C9 aromatics can be considered to be mildly to moderately irritating to the skin, with any effects generally reversible. In addition, a study was conducted in which 26 human volunteers were dermally exposed to C9 aromatics. Results showed no evidence of aromatics being a dermal irritant to humans. Using qualitative weight of evidence reasoning, the C9 Aromatics may cause mild skin irritation, but results are insufficient to classify.

 

Eye Irritation

Hydrocarbons, C9, aromatics

A key study (ExxonMobil, 1990) was conducted to determine the potential of the test material (Hydrocarbons, C9, aromatics) to cause irritation to the eye in a rabbit model system. Six rabbits were instilled with 0.1 mL of the test material, neat. Ocular examinations occurred at 1, 4, 24, 48, and 72 hrs, and days 4 and 7 post instillation. Ocular damage was assessed and scored according to the Draize eye test. All animals survived the exposure. Maximum observed Draize score was 8. Irritation subsided as the study progressed and all animals were clear of ocular irritation after the 48 hr observation. Based on the individual and mean scores, test material should not be considered an ocular irritant under either EU GHS guidelines.

Respiratory Irritation

No studies were located to indicate that Hydrocarbons, C10, aromatics, <1% naphthalene is a respiratory irritant.

Justification for classification or non-classification

Skin Irritation:

Based on available read across data, Hydrocarbons, C10, aromatics, <1% naphthalene does not meet the criteria for classification for skin Irritation under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).

 

Ocular Irritation:

Based on available read across data, Hydrocarbons, C10, aromatics, <1% naphthalene does not meet the criteria for classification as ocular irritants 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).