Butanoic acid, 3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-indenyl ester

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

from 24-09-2001 to 08-02-2002

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study performed in accordance with Standard Operating Procedures of Hill Top Research, INC. No official guideline available.

Cross-reference

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

The skin sensitising properties of Cyclobutanate were investigated in a Human Repeated Insult Patch Test (HRIPT), in which human volunteers were induced during 9 treatments, followed by a challenge treatment.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

441-420-8

EC Name:

-

Cas Number:

113889-23-9

Molecular formula:

C14H20O2

IUPAC Name:

tricyclo[5.2.1.0²,⁶]dec-3-en-8-yl butanoate; tricyclo[5.2.1.0²,⁶]dec-4-en-8-yl butanoate

Test material form:

liquid

Method

Type of population:

general

Ethical approval:

not specified

Subjects:

- Number of subjects exposed: 129 (114 subjects completed the study)
- Sex: M (12) / F (102)
- No information on age and race
- Demographic information: no information available

Clinical history:

No information available.

Controls:

Yes, standard control substance taken into account

Route of administration:

dermal

Details on study design:

TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: Occlusive
- Description of patch: No information available
- Vehicle / solvent: No information
- Concentrations: 5%
- Volume applied: 0.2 mL/patch
- Testing/scoring schedule: 9 induction treatments followed by a challenge which was read at 24, 48 and 72h
- Removal of test substance: no information available
- Other: test site: paraspinal region of the back

EXAMINATIONS
- Grading/Scoring system:
0 No visible reaction
1 Mild reaction
2 Moderate reaction
3 Severe reaction

Results and discussion

Results of examinations:

SYMPTOMS
- Frequency, level, duration of symptoms observed:
Reactions to Cyclobutanate: isolated instance of mild erythema, at the challenge 2 instances of mild and one of moderate erythema were observed at the 24-hour evaluation, and were all resolved by the 48-hour evaluation.
Reactions to test substance B (control): mild erythema for subject No. 38 after application 2 which was resolved by application 6. At the challenge a single instance of mild erythema was observed at the 24-hour evaluation which was resolved by the 48-hour evaluation.
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 2
- Number of subjects with negative reactions: 112
- Number of subjects with equivocal reactions: 0
- Number of subjects with irritating reactions: 0

RESULT OF CASE REPORT: For the 2 subjects who exhibited a positive challenge, No. 28 and 49, a rechallenge was performed under the same testing conditions as specified in the original protocol. There was no sensitization indicated at rechallenge at the 24-, 48-, and 72-hour evaluations.

Applicant's summary and conclusion

Conclusions:

In a Human Repeated Insult Patch Test performed with human volunteers, a positive skin reaction at challenge was seen in 2 out of 114 test subjects. These subjects were rechallenged and no skin sensitization was indicated at 24, 48 and 72 hours after rechallenge application.

Executive summary:

The sensitising potential of Cyclobutanate was determined in a Human Repeated Insult Patch Test (HRIPT), which was performed according to Standard Operating Procedures of the research lab (no guideline available). Topical application was performed with 5% Cyclobutanate and a control substance.

Reactions to Cyclobutanate: isolated instance of mild erythema, at the challenge 2 instances of mild and one of moderate erythema were observed at the 24-hour evaluation, and were all resolved by the 48-hour evaluation. Reactions to the control substance: mild erythema for subject No. 38 after application 2 which was resolved by application 6. At the challenge a single instance of mild erythema was observed at the 24-hour evaluation which was resolved by the 48-hour evaluation.

Under the conditions of this study, a positive skin reaction at challenge was seen in 2 out of 114 test subjects. These subjects were rechallenged and no sensitization was indicated at 24, 48 and 72 hours after rechallenge application.