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EC number: 946-365-8 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- 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.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- 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 for cross-reference:
- read-across source
- 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.
- 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 data is being read across from the source study that tested Hydrocarbons, C9, aromatics based on analogue read across.
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.
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 | |||
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Directive 67/548/EEC (OECD TG 404)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Hydrocarbons, C9, aromatics
- EC Number:
- 918-668-5
- Molecular formula:
- C9H12
- IUPAC Name:
- Hydrocarbons, C9, aromatics
Constituent 1
Test animals
- 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
Test system
- 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
Results and discussion
In vivo
Resultsopen allclose all
- 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.
Any other information on results incl. tables
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 | |||
Applicant's summary and conclusion
- 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.
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