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Diss Factsheets

Administrative data

Description of key information

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.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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
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
Specific details on test material used for the study:
SRJID or Lot I.D. Number: 7482-9A
Physical State and Appearance: Colorless liquid
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
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
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
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
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.

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

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The respective criteria are not met. Therefore ethylcyclohexane has not to be classified for skin sensitisation.