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Diss Factsheets

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:
supporting study
Study period:
Not reported
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: A non GLP study performed to sound scientific principles with a sufficient level of detail to assess the quality of the submitted data.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
A preliminary skin irritation study was performed prior to initiation of the sensitisation study. The irritation study was conducted to define the concentration to be used for the definitive test; the maximum non-irritating concentration and the minimum irritant concentration. Each animal received a topical induction with the test material at concentrations of 100, 30, 10 or 3% for 21 consecutive days. Animals then received two topical challenge exposures at or below the minimum irritating concentration. Sensitisation was then measured 24, 48 and/or 72 hours after challenge application.
GLP compliance:
no
Remarks:
Study predates GLP.
Type of study:
open epicutaneous test

Test material

Constituent 1
Chemical structure
Reference substance name:
4-methyl-3-decen-5-ol
EC Number:
279-815-0
EC Name:
4-methyl-3-decen-5-ol
Cas Number:
81782-77-6
Molecular formula:
C11H22O
IUPAC Name:
4-methyldec-3-en-5-ol
Test material form:
liquid

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, open
Vehicle:
other: Ethanol
Concentration / amount:
100, 30, 10 and 3%
Challengeopen allclose all
Route:
epicutaneous, open
Vehicle:
other: Ethanol
Concentration / amount:
100, 30, 10 and 3%
No. of animals per dose:
One to six groups of animals were used per concentration, where each group consisted of 6 to 8 animals.
Details on study design:
RANGE FINDING TESTS: A single 0.025 mL application of each test concentration was applied to a 2 cm² patch of skin, previously clipped free of hair. The test material was applied at the following concentrations; 100, 30, 10 and 3%. The skin reaction was recorded 24 hours after application. The minimum irritant and maximum non-irritant concentrations were taken forward to the definitive test. The minimum irritant concentration was defined as the lowest concentration that caused skin irritation; the maximum non-irritant concentration was defined as the highest concentration that did not elicit a macroscopic skin reaction. The lowest irritation concentration after a single application was determined to be 30% and the highest non-irritating concentration was 10%.MAIN STUDYA. INDUCTION EXPOSURE- Site: 8 cm² on the clipped flank of each animal.- Frequency of applications: Daily.- Duration: Three weeks.- Observations: The skin irritation was observed 4 hours after application or at the end of each week. The maximum non-irritant and minimal irritation concentrations were also recorded.- Concentrations: 100, 30, 10 and 3%.- Application: A 0.1 mL aliquot of each test solution was applied using a pipette.- Observation: Skin irritation was measured 24 hours after application or at the end of the week. The application site was changed for animals which displayed a very strong reaction.B. CHALLENGE EXPOSURE- No. of exposures: Two exposures.- Days of challenge: 21 and 35.- Site: The 2 cm² area on the contralateral flank of each animal.- Concentrations: The test material was applied at concentrations at the minimal irritating concentration and some lower concentrations.- Application: A 0.025 mL aliquot was applied using a pipette.- Evaluation (hr after challenge): Reactions were scored 24, 48 and/or 72 hours after application.
Challenge controls:
Six to eight untreated animals (or animals pre-treated with the vehicle) were submitted for the challenge exposure as described above.
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
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10
No. with + reactions:
0
Total no. in group:
6
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
72
Group:
test chemical
Dose level:
10
No. with + reactions:
0
Total no. in group:
6
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10
No. with + reactions:
0
Total no. in group:
6
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10
No. with + reactions:
0
Total no. in group:
6
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
10
No. with + reactions:
0
Total no. in group:
6
Remarks on result:
no indication of skin sensitisation
Group:
positive control
Remarks on result:
not measured/tested
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
10
No. with + reactions:
0
Total no. in group:
6
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
10
No. with + reactions:
0
Total no. in group:
6
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
72
Group:
negative control
Dose level:
10
No. with + reactions:
0
Total no. in group:
6
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
24
Group:
negative control
Dose level:
10
No. with + reactions:
0
Total no. in group:
6
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
10
No. with + reactions:
0
Total no. in group:
6
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
10
No. with + reactions:
0
Total no. in group:
6
Remarks on result:
other:

Any other information on results incl. tables

Results

The highest non-irritating concentration after a single application of the test material in ethanol was 10%. Only very slight skin irritation occurred with repeated applications.

Table 1. Skin Irritation

Concentration %

Skin Irritation After Days

7

14

21

100

++*

++*

+

30

+

++*

+

10

(+)

(+)

(+)

3

-

-

-

Degree of skin irritation; - none, + slight, ++ moderate, +++ strong.

* Application site was changed.

Table 2. Skin Sensitization

Induction Concentration %

Sensitization Rate (Number of Positive Animals/ Total tested)

Day 21

Day 35

100

0/6

0/6

30

0/6

0/6

10

0/6

0/6

3

0/6

0/6

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of the test, none of the tested animals elicited a positive reaction to the challenge exposure. Accordingly the test material was considered to be non-sensitizing.
Executive summary:

The skin sensitisation potential of the test material was determined in an open epicutaneous test. This study predates GLP and was performed to sound scientific principles.

A preliminary test was conducted to define the test concentrations for the definitive test; the maximum non-irritating and minimum irritant concentrations. In the definitive test, guinea pigs received daily topical induction applications of the test material in solution with ethanol at 100, 30, 10 and 3% for 21 consecutive days. A 0.1 mL aliquot of the appropriate test solution was applied to an area 8 cm² located on the flank of each animal and left uncovered. Each animal was challenged on the untreated flank on days 21 and 35 with a 10% of less test solution. The sensitisation potential was scored 24, 48 or 72 hours after challenge.

Under the conditions of the test, the highest non-irritating concentration after a single application of the test material in ethanol was 10%. Only very slight skin irritation occurred with repeated applications. None of the tested animals elicited a positive reaction to the challenge exposure. Accordingly the test material was considered to be non-sensitizing.