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EC number: 216-835-0 | CAS number: 1678-91-7
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1992-02-05 - 1992-03-19
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- other: footpad method
- Justification for non-LLNA method:
- no other study available
Test material
- Reference substance name:
- Ethylcyclohexane
- EC Number:
- 216-835-0
- EC Name:
- Ethylcyclohexane
- Cas Number:
- 1678-91-7
- Molecular formula:
- C8H16
- IUPAC Name:
- ethylcyclohexane
- Test material form:
- liquid: volatile
Constituent 1
- Specific details on test material used for the study:
- SRJID or Lot I.D. Number: 7482-9A
Physical State and Appearance: Colorless liquid
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Crl:(HA)BR VAF/PlusT
- Sex:
- not specified
- Details on test animals and environmental conditions:
- Source: Charles River Laboratories, Kingston, NY, USA
For Primary Irritation Screen:
No. of Animals: 5/dose
Sex: Not determined
Body Weight Range (grams): 537 -589
Age: Not determined
For Sensitization Study (Induction and Challenge):
No. of Animals: 20; 10 control and 10 test animals
Sex: Female
Body Weight Range (grams): 373 - 465
Age at Study Initiation: 6-7 weeks
Housing:
All animals were individually housed in suspended, stainless-steel, mesh cages.
Environmental Conditions:
A photoperiod of 12 hours light from 6 a.mn. to 6 p.m. was maintained. Room temperature was maintained at 68-75'F. Relative humidity was maintained at 45-47%.
Diet and Water:
ad libitum
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- other: Freund's complete adjuvant
- Concentration / amount:
- 1%
- Day(s)/duration:
- 7 days
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, open
- Vehicle:
- other: acetone, dioxane, and guinea pig fat (7:2: 1).
- Concentration / amount:
- 10%
- Day(s)/duration:
- 48 days
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 5
- Details on study design:
- Primary Irritation Screen:
Five animals per dose group, previously assigned as controls on a footpad sensitization study, were tested for primary skin irritation. Hair was removed from the backs of the animals with an electric clipper and 0.3 mL of a 1.0% solution of the test compound in a mixture of acetone, dioxane, and guinea pig fat (7:2: 1) was applied to the clipped area. Twenty-four hours later, the animals were depilated and scored for edema and erythema. The skin reaction was also scored at 48 hours. The highest average score for either day determined the concentration to be used in the challenge dose of the main study. The challenge dose was based on the following criteria. If the average was 0, a 10% solution
was used for the challenge dose. If the average was 0.2 to 0.6, a 3% solution was used for the challenge dose. If the average was 0. 8 to 1. 2, a 1 % solution was used for the challenge dose and if the average was 1.4 or more, a 0. 1% solution was used.
Sensitization Procedure:
Ten animals were injected in the footpad with 0.05 mL of Freund's complete adjuvant (control group). At the same time, 10 other animals were injected in the same manner with 0.05 mL of Freund's containing 1 % test compound (test group). Seven days later the hair was removed
from the backs of the animals with an electric clipper. The animals were then challenged with 0.3 mL of a solution of the test material (at the concentration determined in the previous step) in acetone, dioxane, and guinea pig fat (7:2: 1). The animals were depilated 24 hours after
the challenge dose and the reaction to the topical challenge was scored. The next day (48 hours after challenge) the reaction was scored again. - Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- no dose level tested
- Remarks on result:
- not measured/tested
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on these results, the test material was not considered to be a dermal sensitizer in guinea pigs. Furthermore, the lack of any positive response at challenge indicates that the test material has a low potential for human dermal sensitization.
- Executive summary:
A dermal sensitization study was conducted with this test material in guinea pigs using the footpad method. No signs of irritation were evident at the application site for five animals administered 1.0% of the test material in the initial primary irritation screen. Therefore, the concentration used in the challenge dose of the sensitization study was set at 10.0%. In the sensitization study, no dermal responses were evident for animals previously induced with Freund's adjuvant (control animals) and for animals previously induced with the test material in Freund's adjuvant (test animals). All animals in both groups were graded as having no
response to the test material at challenge. Based on these results, the test material was not considered to be a dermal sensitizer in guinea pigs. The lack of any positive response at challenge indicates that the test material has a low potential for human dermal sensitization. Since none of the animals responded positively, the test material is not classified with respect to skin sensitisation.
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