3(or 4)-(4-methylpenten-3-yl)cyclohex-3-ene-1-methyl acetate

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1972

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Original reference in German; no data about the purity and no certificate of analysis of the test substance; no information on the strain, age, sex, body weight, source and housing conditions of the animals; individual animal data were not reported

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1972

Report date:

1972

Materials and methods

Principles of method if other than guideline:

Method: Open epicutaneous test

GLP compliance:

no

Remarks:

pre-GLP

Type of study:

open epicutaneous test

Test material

Test material information

Constituent 1

Reference substance name:

3(or 4)-(4-methylpenten-3-yl)cyclohex-3-ene-1-methyl acetate

EC Number:

276-650-6

EC Name:

3(or 4)-(4-methylpenten-3-yl)cyclohex-3-ene-1-methyl acetate

Cas Number:

72403-67-9

Molecular formula:

C15H24O2

IUPAC Name:

[3-(4-methylpent-3-en-1-yl)cyclohex-3-en-1-yl]methyl acetate; [4-(4-methylpent-3-en-1-yl)cyclohex-3-en-1-yl]methyl acetate

Test material form:

not specified

Details on test material:

- Name of test material (as cited in study report): ACETATE MYRALDYLE

In vivo test system

Test animals

Species:

guinea pig

Strain:

not specified

Sex:

not specified

Details on test animals and environmental conditions:

None

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

epicutaneous, open

Vehicle:

other: acetone

Induction 2

Concentration / amount:

Preliminary test: 100, 30, 10 and 3 % or lower in acetone

Main test:
- Topical induction exposure: 100, 30, 10 and 3 %
- Topical challenge exposures: Minimal irritating (3 %) and lower concentrations

Challenge

Challenge 1

Route:

epicutaneous, open

Vehicle:

other: acetone

Challenge 2

Concentration / amount:

Preliminary test: 100, 30, 10 and 3 % or lower in acetone

Main test:
- Topical induction exposure: 100, 30, 10 and 3 %
- Topical challenge exposures: Minimal irritating (3 %) and lower concentrations

No. of animals per dose:

6-8 guinea pig

Details on study design:

PRELIMINARY TEST (skin irritation):
- Estimation of threshold-toxic concentration: One day before starting the induction procedure, 0.025 mL of each test concentration (100, 30, 10 and 3 % or lower in acetone) was applied directly to the clipped flank skin (2 cm2) of the guinea pigs and the skin reactions were observed after 24 h. The minimal irritant and the maximal non-irritant concentrations were determined by an all-or-none criterion.

MAIN STUDY
A. INDUCTION EXPOSURE: EPICUTANEOUS
- No. of exposures: 21
- Test groups: 0.1 mL of each test concentration was applied directly to the skin of animals and the application sites were left uncovered.
- Site: Clipped flank skin (8 cm2)
- Frequency of applications: Once daily for 3 weeks
- Evaluation of skin reactions: 24 h after application or at the end of each week
- Duration: Days 0-20

B. CHALLENGE EXPOSURE: EPICUTANEOUS
- No. of exposures: Two
- Day of challenge: No data
- Test groups: 0.025 mL of each test concentration was applied directly to the skin and the application sites were left uncovered.
- Site: Contralateral flank skin (2 cm2)
- Evaluation (h after application): 24, 48 and/or 72 h

Challenge controls:

On the scheduled day of challenge, 0.025 mL of each test concentration was applied directly to the skin of vehicle treated or untreated control animals. The application sites were left uncovered and observed for skin reactions after 24, 48 and/or 72 h.

Positive control substance(s):

no

Results and discussion

Positive control results:

Not applicable

In vivo (non-LLNA)

Results

Reading:

other: Day of challenge (readings at 24, 48 and/or 72 h)

Hours after challenge:

72

Group:

test chemical

Dose level:

Induction: 3-100 %; challenge: 3 % or lower

No. with + reactions:

0

Total no. in group:

6

Clinical observations:

no data on clinical signs; no. of animals = 6-8/group

Remarks on result:

other: see Remark

Remarks:

Reading: other: Day of challenge (readings at 24, 48 and/or 72 h). . Hours after challenge: 72.0. Group: test group. Dose level: Induction: 3-100 %; challenge: 3 % or lower. No with. + reactions: 0.0. Total no. in groups: 6.0. Clinical observations: no data on clinical signs; no. of animals = 6-8/group.

Any other information on results incl. tables

Preliminary test:

- Lowest irritant concentration: 3 %

- Highest non-irritant concentration: 1 %

 

Table 7.4.1/1: Main test: skin irritation after repeated applications over 21 successive days

 

Concentration in %	Skin irritation after days
	7	14	21
100	slight	moderate	very strong
30	slight	moderate	very strong
10	very slight	slight	moderate
3	very slight	very slight	very slight

 

Table 7.4.1/2: Main test: capacity to induce allergic sensitisation

 

Concentration in % (after daily applications over 3 weeks)	Sensitisation
100	Negative
30	Negative
10	Negative
3	Negative

 

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under these test conditions, ACETATE MYRALDYLE was considered not to be a skin sensitiser to guinea pig.

Executive summary:

In an open epicutaneous test (OET), groups of guinea pigs (6 -8/group) were epicutaneously induced with 0.1 mL of the test item, ACETATE MYRALDYLE, at concentrations of 100, 30, 10 and 3 % in acetone. Each test concentration was applied directly to the clipped flank skin (8 cm2) of guinea pigs, once daily for 21 successive days (Days 0-20) and then the application sites were left uncovered. On the scheduled day for challenge exposure, 0.025 mL of the test item at the minimal irritating (3 %) and some lower concentrations were applied to the contralateral skin of previously treated and untreated or vehicle treated animals.

No skin reactions were noted at the challenged sites of the test group animals. ACETATE MYRALDYLE produced a 0 % sensitisation rate and was considered not to be a skin sensitiser to guinea pig.

Under these test conditions, ACETATE MYRALDYLE was considered not to be a skin sensitiser to guinea pig.