Registration Dossier

Administrative data

Description of key information

Hydrocarbons, C9-C10, aromatics, >1% Naphthalene are a combination of Hydrocarbons, C9 Aromatics and Hydrocarbons, C10-C12 Aromatics. Read across data is available for Hydrocarbons, C9 Aromatics and Hydrocarbons, C10-C12 Aromatics and the worst case scenario for each end point has been presented.

 

Hydrocarbons, C9 Aromatics:

 

Skin Irritation - Hydrocarbons, C9, Aromatics are not corrosives and are mild to moderate dermal irritants for rabbit (OECD TG 404). A series of skin irritation studies were conducted using rabbits and standard test protocols.The mean erythema scores in the four independent key studies ranged from 1.9 to 4.0; mean edema scores in these same studies ranged from 0.0 to 2.2. Therefore, 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. 

 

Ocular Irritation - not ocular irritants 

 

Respiratory Irritation - not respiratory irritants

 

Hydrocarbons, C10-C12 Aromatics:

 

Skin Irritation - not corrosives or dermal irritants

 

Ocular Irritation - not ocular irritants 

 

Respiratory Irritation - not respiratory irritants

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:
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:
Hydrocarbons, C9-C10, aromatics, >1% Naphthalene are a combination of Hydrocarbons, C9 Aromatics and Hydrocarbons, C10-C12 Aromatics. Read across data is available for Hydrocarbons, C9 Aromatics and Hydrocarbons, C10-C12 Aromatics and the worst case scenario for each end point has been presented.
Reason / purpose:
read-across: supporting information
Qualifier:
according to
Guideline:
other: Directive 67/548/EEC (OECD TG 404)
GLP compliance:
yes (incl. certificate)
Species:
rabbit
Strain:
New Zealand White
Details on test animals 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 
  Edema 
TT019 M  Erythema 
  Edema  0c 
TT021 M  Erythema 
  Edema  0d 
TT036 F  Erythema
  Edema  0c 
TT038 F  Erythema 
  Edema  0c 
 TT043 F Erythema  1
  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:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1989/12/04 -1989/12/07
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: According to or similar to guideline study OECD 404: GLP
Justification for type of information:
Hydrocarbons, C9-C10, aromatics, >1% Naphthalene are a combination of Hydrocarbons, C9 Aromatics and Hydrocarbons, C10-C12 Aromatics. Read across data is available for Hydrocarbons, C9 Aromatics and Hydrocarbons, C10-C12 Aromatics and the worst case scenario for each end point has been presented.
Reason / purpose:
read-across: supporting information
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
Source: l'Abbaye de Bellefontaine
Sex: Male (6)
Age at study initiation: Approximately 12 weeks
Weight at study initiation: 2.5 +/- 0.1 kg
Housing: Individually
Diet (e.g. ad libitum): ad libitum
Water (e.g. ad libitum): Automatic watering system, ad libitum
Acclimation period: 5

ENVIRONMENTAL CONDITIONS
Temperature (°C): 20 +/- 3
Humidity (%): 30-70%
Photoperiod (hrs dark / hrs light): 12/12
Monitored at least once a day
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
Amount(s) applied (volume or weight): 0.5 ml
Concentration (if solution): neat
Duration of treatment / exposure:
Test material was administered to the clipped backs as a single dose introduced under a gauze patch and held in contact with the skin by means of a semi-occlusive dressing for 4 hours. Residual test material was then removed.
Observation period:
1, 24, 48, and 72h post application and once per day on Day 7
Number of animals:
Male (6)
Details on study design:
SCORING SYSTEM: Draize scale for dermal irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1 hour
Score:
ca. 1.7
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
ca. 1.8
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Score:
ca. 1.2
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
ca. 1
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
1.3
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1 hour
Score:
ca. 2.7
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
ca. 1
Irritation parameter:
edema score
Basis:
mean
Time point:
48 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0.33
Irritant / corrosive response data:
Topical application of Coupe Aromatique 180 -230 elicited mild dermal responses. The erythema was noted as slight at the 72 hour time point while the edema that was noted in the animals was completely reversed by the 48 hour observation.
Interpretation of results:
other: Not irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The average erythema score (24,48, and 72 hours) was 1.3. The average edema score (24,48, and 72 hours) was 0.33.

Classification as a dermal irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
Executive summary:

In this study, 6 rabbits were subjected to a 4h dermal (shaved) exposure of 0.5 ml of Coupe Aromatique 180-230 via a semi-occluded patch. Dermal responses were evaluated at 1, 24, 48, and 72h post-dosing according to the Draize method of scoring.

At the 1, 24, and 72 hour observations two animals were noted with a well defined erythema and edema. The average erythema score (24,48, and 72 hours) was 1.3. The average edema score (24,48, and 72 hours) was 0.33.

Classification as a dermal irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1989/12/12 - 1990/1/31
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: In agreement with OECD test guideline 404. GLP
Justification for type of information:
Hydrocarbons, C9-C10, aromatics, >1% Naphthalene are a combination of Hydrocarbons, C9 Aromatics and Hydrocarbons, C10-C12 Aromatics. Read across data is available for Hydrocarbons, C9 Aromatics and Hydrocarbons, C10-C12 Aromatics and the worst case scenario for each end point has been presented.
Reason / purpose:
read-across: supporting information
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
Source: Hazleton Research Products
Sex: Male (3), Female (3)
Age at study initiation: Approximately 12 weeks
Weight at study initiation: 2.00-3.00 kg
Housing: Individually
Diet (e.g. ad libitum): Agway Certified Diet R.C.A. Rabbit (pellets), restricted as per recommendation of supplier
Water (e.g. ad libitum): Automatic watering system, ad libitum
Acclimation period: 22d

ENVIRONMENTAL CONDITIONS
Temperature (°F): 65 to 74
Humidity (%): 30-70%
Photoperiod (hrs dark / hrs light): 12/12
Monitored at least once a day
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
Amount(s) applied (volume or weight): 0.5 ml
Concentration (if solution): neat
Duration of treatment / exposure:
Test material was administered to the clipped backs as a single dose introduced under a gauze patch (secured with non-irritating tape) and held in contact with the skin by means of a semi-occlusive dressing for 4 hours. Residual test material was then removed.
Observation period:
45 min, 24, 48, and 72h post application and once per day on Day 7
Number of animals:
Male (3), Female (3)
Details on study design:
SCORING SYSTEM: Draize scale for dermal irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1 hour
Score:
ca. 1
Max. score:
2
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
ca. 1
Max. score:
2
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Score:
ca. 0.83
Max. score:
2
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
ca. 2
Max. score:
2
Irritation parameter:
erythema score
Basis:
mean
Time point:
7 d
Score:
ca. 0.67
Max. score:
1
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1 hour
Score:
ca. 0.33
Max. score:
1
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
48 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
ca. 0.17
Max. score:
1
Irritation parameter:
edema score
Basis:
mean
Time point:
7 d
Score:
ca. 0
Max. score:
0
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0.94
Irritant / corrosive response data:
Topical application of MRD-89-524 elicited dermal responses in 4 out of 6 animals. At the 1, 24, and 72 hour observations two animals were noted with a well defined erythema and very slight edema. One animal was noted with well defined erythema and three animals were noted with very slight erythema at the 48 hour observation. At day 7, four animals were noted with very slight erythema.
Interpretation of results:
other: Not irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The average erythema score (24,48, and 72 hours) was 0.94. The average edema score (24,48, and 72 hours) was 0.06.

Classification as a dermal irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
Executive summary:

In this study, 6 rabbits were subjected to a 4h dermal (shaved) exposure of 0.5 mL of MRD-89-524 via a semi-occluded patch. Dermal responses were evaluated at 1, 24, 48, and 72h post-dosing and on day 7 according to the Draize method of scoring.

At the 1, 24, and 72 hour observations two animals were noted with a well defined erythema and very slight edema.  One animal was noted with well defined erythema and three animals were noted with very slight erythema at the 48 hour observation. At day 7, four animals were noted with very slight erythema. The average erythema score (24,48, and 72 hours) was 0.94. The average edema score (24,48, and 72 hours) was 0.06.

Classification as a dermal irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.

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

Eye irritation

Link to relevant study records

Referenceopen allclose all

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:
Hydrocarbons, C9-C10, aromatics, >1% Naphthalene are a combination of Hydrocarbons, C9 Aromatics and Hydrocarbons, C10-C12 Aromatics. Read across data is available for Hydrocarbons, C9 Aromatics and Hydrocarbons, C10-C12 Aromatics and the worst case scenario for each end point has been presented.
Reason / purpose:
read-across: supporting information
Qualifier:
equivalent or similar to
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 hours not specified
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: Mean 24, 48, and 72 hours not specified
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: Mean 24, 48, and 72 hours not specified
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: Mean 24, 48, and 72 hours 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:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From April 23, 1990 to May 24, 1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report in agreement with OECD guideline 405-GLP
Justification for type of information:
Hydrocarbons, C9-C10, aromatics, >1% Naphthalene are a combination of Hydrocarbons, C9 Aromatics and Hydrocarbons, C10-C12 Aromatics. Read across data is available for Hydrocarbons, C9 Aromatics and Hydrocarbons, C10-C12 Aromatics and the worst case scenario for each end point has been presented.
Reason / purpose:
read-across: supporting information
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
increased number of animals
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hazleton Research
- Age at study initiation: Approximately 14 weeks
- Weight at study initiation: 2.29-2.75 kg
- Housing: Individual
- Diet (e.g. ad libitum): restricted feeding regimen per manufacturers recommendation
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 15 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): maintained range of 18.3-21.1 °C
- Humidity (%): maintained range of 40-60%
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light


IN-LIFE DATES: From: 1990-05-08 To: 1990-05-22
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.1ml
- Concentration (if solution): undiluted

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, 24, 48, 72 hours post-instillation and once per day on days 4, 7, 10, and 14
Number of animals or in vitro replicates:
Six animals (all females)
Details on study design:
SCORING SYSTEM: Draize Method


TOOL USED TO ASSESS SCORE: 2% sodium fluorescein dye under UV light
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 1.46
Max. score:
8
Reversibility:
fully reversible within: 14 days
Irritation parameter:
other: redness
Basis:
mean
Time point:
other: 1h
Score:
ca. 1.17
Max. score:
2
Irritation parameter:
other: redness
Basis:
mean
Time point:
24 h
Score:
ca. 0.5
Max. score:
1
Irritation parameter:
other: redness
Basis:
mean
Time point:
48 h
Score:
ca. 0.17
Max. score:
1
Irritation parameter:
other: redness
Basis:
mean
Time point:
72 h
Score:
ca. 0.6
Max. score:
1
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1h
Score:
ca. 1.67
Max. score:
2
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24 h
Score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
48 h
Score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
72 h
Score:
ca. 0.2
Max. score:
1
Reversibility:
fully reversible within: 14 days
Other effects:
Alopecia around the treated eye was noted for one animal on days 10 and 14.

One animal died prior to study termination (day 3). This animal exhibited poor food consumption, distended abdomen, and small amount of stool on day 2. It was the opinion of the study director that this death was not test material related, but due to a gastro-intestinal problem.
Interpretation of results:
other: Not irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Classification as an ocular irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
Executive summary:

Application of 0.1 mL of MRD-89-523 to the eye of six rabbits elicited slight, transient conjunctival redness, chemosis, and some discharge. Mean scores for redness at 24, 48, 72 hours were 0.50, 0.17, and 0.60 respectively. The scores for chemosis were 1.67, 0, and 0. There were no positive scores for corneal, or iridial irritation. Ocular irritation was most prominent at the 1 hour, 72 hour and day 4 observations where the total Draize score ranged from 4-12. Additional observations included alopecia in one animal on days 10 and 14. All other animals were free of signs of irritation within 14 days of dosing.  

Classification as an ocular irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Hydrocarbons, C9-C10, aromatics, >1% Naphthalene are a combination of Hydrocarbons, C9 Aromatics and Hydrocarbons, C10-C12 Aromatics. Read across data is available for Hydrocarbons, C9 Aromatics and Hydrocarbons, C10-C12 Aromatics and the worst case scenario for each end point has been presented.

 

Hydrocarbons, C9 Aromatics:

 

Skin Irritation – Hydrocarbons,C9 Aromatics are not corrosives and are mild to moderate dermal irritants for rabbits (OECD TG 404). Topical application of Hydrocarbons, C9 Aromatics to the clipped backs of rabbits under semi-occlusive dressing for 4 hours elicited dermal responses in all animals. The mean erythema scores in the four independent key studies ranged from 1.9 to 4.0; mean edema scores in these same studies ranged from 0.0 to 2.2. Therefore, Hydrocarbons, C9 aromatics can be considered to be mildly to moderately irritating to rabbit skin, with any effects generally reversible. In addition, a study was conducted in which 26 human volunteers were dermally exposed to Hydrocarbons, 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 to rabbits, but are not irritating to human skin.

 

Ocular Irritation – Hydrocarbons, C9 Aromatics are not ocular irritants (OECD TG 405) when evaluated in rabbits following a single 0.1 mL ocular instillation. Testing of Hydrocarbons,C9 Aromatics generally demonstrated reversible conjunctive redness, chemosis, and infrequent discharge in animals. Draize scores were generally low. All study results indicate that the Hydrocarbons,C9 Aromatics are not irritating for rabbits.

 

Respiratory Irritation - No studies were located to indicate that Hydrocarbons, C9 Aromatics are respiratory irritants. However, a constituent of the C9 Aromatics,

1,3,5-trimethylbenzene, is classified as a respiratory irritant (STOT Single Exp. 3: H335) under EU CLP.

 

Hydrocarbons, C10-C12 Aromatics:

 

Skin Irritation - C10-C12 Aromatics are not corrosives or dermal irritants for rabbit (OECD TG 404). Topical application of C10-C12 Aromatics to the clipped backs of

rabbits under semi-occlusive dressing for 4 hours elicited dermal responses in all animals. The dermal responses consisted of erythema ranging from very slight to well defined erythema and very slight edema. A total of 14 animal studies were examined that covered all substance in the category. Five studies used occlusive dressing and did not report sufficient data for classification. Eight studies that were of superior quality and used GLP standards reported data which did not lead to classification. C10-C12 Aromatics are not irritating to human skin when evaluated in a repeated patch test as a 50% w/w preparation. Application of a 50% w/w preparation of C10-C12 Aromatics under semi-occlusive conditions did not result in signs of primary irritation. In another study at the same concentration, application of C10-C12 Aromatics to the skin without or in conjunction with UV irradiation did not elicit an irritation response in any of the study participants. Using qualitative weight of evidence reasoning, the C10-C12 Aromatics are not irritating to rabbit or human skin.

 

Ocular Irritation - C10-C12 Aromatics are not ocular irritants (OECD TG 405) when evaluated in rabbits following a single 0.1 mL ocular instillation. Testing of C10-C12 Aromatics generally demonstrated reversible conjunctive redness, chemosis, and infrequent discharge in animals. Draize scores were generally low. A total of 7 studies were examined that covered all substance in the category. All study results indicate that the C10-C12 Aromatics are not irritating for rabbits.

 

Respiratory Irritation - No studies were located to indicate that C10 -C12 Aromatics are respiratory irritants.

Justification for classification or non-classification

There is no data available for Hydrocarbons, C9-C10, aromatics, >1% Naphthalene. Hydrocarbons, C9-C10, aromatics, >1% Naphthalene are a combination of Hydrocarbons, C9 Aromatics and Hydrocarbons, C10-C12 Aromatics. Based on available read across data, Hydrocarbons, C9-C10, aromatics, >1% Naphthalene do not warrant classification as skin, ocular, or respiratory irritants under the Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP). However, a constituent of Hydrocarbons, C9 Aromatics, 1,3,5-trimethylbenzene, is classified as a respiratory irritant (STOT Single Exp. 3: H335) under EU CLP. Therefore, Hydrocarbons, C9-C10, aromatics, >1% Naphthalene are also classified as respiratory irritants under EU Regulation (EC) 1272/2008.