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Toxicological information

Skin irritation / corrosion

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Administrative data

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.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Directive 67/548/EEC (OECD TG 404)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

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

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:
other: 24, 48, 72 hrs
Score:
1.9
Max. score:
2
Reversibility:
fully reversible within: 21 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 hrs
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 
  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 

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.