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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
April 24 until June 01, 1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
1981
Deviations:
no
GLP compliance:
yes
Type of study:
open epicutaneous test
Justification for non-LLNA method:
The guinea pig test method described in OECD TG 406 provide suitable information for hazard identification.

Test material

Constituent 1
Chemical structure
Reference substance name:
4-pentylcyclohexanone
EC Number:
406-670-4
EC Name:
4-pentylcyclohexanone
Cas Number:
61203-83-6
Molecular formula:
C11H20O
IUPAC Name:
4-pentylcyclohexan-1-one

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Iva : PDH
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: no information
- Age at study initiation: about 4 weeks
- Weight at study initiation: mean 217 (186 - 258) g
- Housing: individual in Makrolon cages type IV
- Diet: ad libitum, Altromin Standard Diet TPF 3012
- Water: ad libitum, tap water
- Acclimation period: 7 days
- Indication of any skin lesions: no

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-30
- Humidity (%): 40-62
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, open
Vehicle:
paraffin oil
Concentration / amount:
0.1 mL
Day(s)/duration:
21
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challengeopen allclose all
No.:
#1
Route:
epicutaneous, open
Vehicle:
paraffin oil
Concentration / amount:
1,3 and 10%
Day(s)/duration:
day 22
Adequacy of challenge:
highest non-irritant concentration
No.:
#2
Route:
epicutaneous, open
Vehicle:
paraffin oil
Concentration / amount:
1,3 and 10%
Day(s)/duration:
day 36
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
6
Details on study design:
RANGE FINDING TESTS: According to the recommendations of KLECAK a pretest to determine the threshold concentration after single application was done with 3, 10, and 30 % preparations. The concentrations of 10 and 30 % did induce skin irritation and thus the concentrations of 3% and 10% were choosen as concentrations for the sensitization study.

MAIN STUDY
A. INDUCTION EXPOSURE
- Test groups: 0.1 mL test material preparation
- Control group: treated with vehicle (liquid paraffin) only
- Site: shaved back
- Frequency of applications: once daily
- Duration: 21 days
- Concentrations: 3% and 10% (groups 3 and 4)

B. CHALLENGE EXPOSURE
- No. of exposures: single
- Day(s) of challenge: day 22 (challenge I) and day 36 (challenge II)
- Control group: vehicle
Half of the untreated control animals (group 1) were treated on challenge I and the rest on challenge II with the test material preparations and the vehicle to exclude primary irritation.
- Site: shaved left flank (challenge I) and shaved right flank (challenge II)
- Concentrations: Each animal of the different test groups was challenged with 3 different test material concentrations (i.e. with 1, 3, and 10 %)
- Evaluation (hr after challenge): During the induction phase the guinea-pigs were investigated for skin reactions daily, about 24 hours after application of the test material always. After challenge they were examined 24, 48, and 72 hours after administration. The skin reactions were classified as: 0 = negative/questionable + =positive
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:
6
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
6
Key result
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
6
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
6
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
6
Key result
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
6
Group:
positive control
Remarks on result:
not measured/tested

Any other information on results incl. tables

Table 1: Results of first challenge

 Time after challenge (h)        24              48           72
 Concentration (g ad 100 mL)  0  1  3  10  0  1  3  10  0  1  3  10
 351  0  0  0  0  0  0  0  0  0  0  0  0
 352  0  0  0  0  0  0  0  0  0  0  0  0
 353  0  0  0  0  0  0  0  0  0  0  0  0
 354  0  0  0  0  0  0  0  0  0  0  0  0
 355  0  0  0  0  0  0  +  0  0  +  +  0
 356  0  0  0  0  0  0  0  0  0  0  0  0

Findings after challenge

After the first challenge none of the guinea-pigs of the test material group 3 or the control groups showed any positive skin reaction. One animal (No. 355) in group 4 (induction with 10 %) showed positive skin reaction to the 3 % test material preparation at the 48 h and 72 h readings and to the 1 % test material preparation after 72 h . After the second challenge none of the guinea-pigs of the test material or control groups showed any positive reaction.

Findings in the induction phase

Due to the test material and the vehicle the skin at the treatment sites showed erythema and/or scales in the induction phase (groups 2-4).

Clinical findings, body weight and mortality

All the guinea-pigs behaved normally and were without clinical symptoms during the study period. The body weight development was normal (Table 2) and no animal died.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item is not to be classified as skin sensitizer.
Executive summary:

A study according OECD TG 406 was conducted to test for skin sensitizing properties in guinea-pigs in the Open Epicutaneous Test (OET). Four groups with 6 female guinea-pigs, each, were investigated:

Group 1 and group 2 were controls. Group 3 was treated with 0.1 mL of 3 % test item, and group 4 with 0.1 mL of 10 test item, during the 21 day induction phase.

During this period erythema and/or scales were observed at the treated skin in groups 2-4.

After the first challenge on day 22 with test material concentrations of 1, 3, and 10 %, no skin reaction was observed in group 3. One of the 6 guinea-pigs treated with 10 % test material preparation in the induction phase showed positive skin reactions after 48 and 72 hours to 1 and 3% substance.

After the second challenge, on day 36 of the study, with the same concentrations, none of the challenge sites in any of the guinea-pigs showed a positive reaction.

The results indicate borderline sensitization only by exposition to 10 % test item, since at the second challenge no skin reaction was detectable.

Thus. the test item is not to be classified as skin sensitizer.