2-ethynyltetrahydro-2,6,6-trimethyl-2H-pyran

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1982-03-18 - 1982-04-29

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study similar to guideline. Limited substance information (e.g. purity).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Principles of method if other than guideline:

The technique employed in the study was that of the repeated insulin method approved by the Food and Drug Administration and known as Draize technique.

GLP compliance:

no

Type of study:

patch test

Test material

Test material information

Constituent 1

Reference substance name:

2-ethynyltetrahydro-2,6,6-trimethyl-2H-pyran

EC Number:

237-551-3

EC Name:

2-ethynyltetrahydro-2,6,6-trimethyl-2H-pyran

Cas Number:

13837-60-0

Molecular formula:

C10H16O

IUPAC Name:

2-ethynyl-2,6,6-trimethyloxane

Test material form:

other: liquid

Details on test material:

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

In vivo test system

Test animals

Species:

human

Strain:

not specified

Sex:

male/female

Details on test animals and environmental conditions:

Sixty subjects were selected on a random basis in order of their applying for participation in the study except that no person was accepted with active dermatologic conditions or other discernible illnesses.

Study design: in vivo (non-LLNA)

Induction

Induction 1

Vehicle:

no data

Induction 2

Concentration / amount:

2% Lyptol in Dimethyl phthalate

Challenge

Challenge 1

Vehicle:

no data

Challenge 2

Concentration / amount:

2% Lyptol in Dimethyl phthalate

No. of animals per dose:

54

Results and discussion

Positive control results:

No data.

In vivo (non-LLNA)

Results

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

neat

No. with + reactions:

0

Total no. in group:

1

Clinical observations:

irritation noted due to tape reaction

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: neat. No with. + reactions: 0.0. Total no. in groups: 1.0. Clinical observations: irritation noted due to tape reaction.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: not specified

Conclusions:

Lyptol was found to be not sensitising in a Human Repeated Insult Patch Test, according to the Draize technique.

Executive summary:

In a Human Repeated Insult Patch Test, according to the Draize technique but conducted prior to the introduction of GLP or the applicable OECD test guideline, Lyptol FAB was found to be non sensitising as it produced no allergic or irritative reactions.