Oxirane, 2,2'-[(octahydro-4,7-methano-1H-indene-2,5-diyl)bis(2,1-phenyleneoxymethylene)]bis-

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1983

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: No GLP guideline study.

Justification for type of information:

Study carried out before introduction of REACH regulation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: The guinea pig sensitization test used is a modification of the method of Maquire (1973), (Repeated insult patch test)

Deviations:

not specified

GLP compliance:

no

Type of study:

patch test

Justification for non-LLNA method:

Study carried out before introduction of REACH regulation

Test material

Test material information

Constituent 1

Reference substance name:

2,2'-{octahydro-1H-4,7-methanoindene-2,5-diylbis[(2,1-phenylene)oxymethylene]}bis(oxirane)

EC Number:

943-519-6

Cas Number:

2149603-92-7

Molecular formula:

C28H32O4

IUPAC Name:

2,2'-{octahydro-1H-4,7-methanoindene-2,5-diylbis[(2,1-phenylene)oxymethylene]}bis(oxirane)

Test material form:

not specified

In vivo test system

Test animals

Species:

guinea pig

Strain:

Hartley

Sex:

male

Details on test animals and environmental conditions:

The skin sensitization test was conducted on male Hartley albino guinea pigs (Buckberg Lab Animals, Inc., Tomkins Cove, New York). All animals
were maintained on a 12-hour photocycle in animal care facilities fully accredited by the American Association for Accreditation of Laboratory Animal Care. They were supplied with Purina Guinea Pig Chow #5025 (Ralston Purina Company, St. Louis, Missouri) and water ad libitum. All guinea pigs
were acclimated to the laboratory environment at least 7 days prior to testing, and were housed 5/cage. All animals were weighed once each week
during the acclimation period and throughout the course of the study.
Each guinea pig was uniquely identified by an individual metal ear tag and was also color coded for easier identification during the study.

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

intradermal

Vehicle:

other: DOWANOL DPM glycol ether product: Tween 80 surfactant (9:1)

Induction 2

Concentration / amount:

5% solution of the test material

Challenge

Challenge 1

Route:

other: epicutaneous

Vehicle:

other: DOWANOL DPM glycol ether product: Tween 80 surfactant (9:1)

Challenge 2

Concentration / amount:

5% solution of the test material

No. of animals per dose:

10 males

Positive control substance(s):

yes

Remarks:

Diglycidyl ether of bisphenol A (known to be a mild sensitizer)

Results and discussion

Positive control results:

Slight to moderate redness with very slight to slight edema was observed on the challenge site of all 10 guinea pigs treated with the positive control
(diglycidyl ether of bisphenol A).

In vivo (non-LLNA)

Results

Results 1

Reading:

other: see remark

Group:

positive control

Dose level:

10% solution on DOWANOL PM/Tween 80 (9:1).

No. with + reactions:

10

Total no. in group:

10

Clinical observations:

Diglycidyl ether of bisphenol A used as positive control. Slight to mederate redness with very slight to slight edema was observed on the challenge site of all 10 guinea pigs treated.

Remarks on result:

other: see Remark

Remarks:

Group: positive control. Dose level: 10% solution on DOWANOL PM/Tween 80 (9:1).. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: Diglycidyl ether of bisphenol A used as positive control. Slight to mederate redness with very slight to slight edema was observed on the challenge site of all 10 guinea pigs treated..

Results 2

Reading:

other: See remark

Group:

test chemical

Dose level:

5% solution of the test material in DOWANOL PM gkycol ether product: Tween 80 surfactant (9:1)

No. with + reactions:

1

Total no. in group:

10

Clinical observations:

Very slight redness was observed at the challenge site of 1/10 animals treated with the test item. This was not considered a positive response, as very slight redness was also observed on the corresponding challenge site treated only with the solvent.

Remarks on result:

other: see Remark

Remarks:

Group: test group. Dose level: 5% solution of the test material in DOWANOL PM gkycol ether product: Tween 80 surfactant (9:1). No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: Very slight redness was observed at the challenge site of 1/10 animals treated with the test item. This was not considered a positive response, as very slight redness was also observed on the corresponding challenge site treated only with the solvent. .

Results 3

Reading:

other: N/A

Group:

negative control

Remarks on result:

not measured/tested

Any other information on results incl. tables

Very slight redness was observed at the challenge site of only 1 of 10 animals treated with the test material.

This was not considered a positive response, as very slight redness was also observed on the corresponding challenge site treated only with the solvent. Therefore, as a 5% solution in D0WAN0L PH/Tween 80 (9:1) dicyclopentadiene novolac epoxide is not considered a positive skin sensitizer to guinea pigs.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Migrated information

Conclusions:

Dicyclopentadiene novalac epoxide is not likely to be a potent human skin sensitizer, based on results of the guinea pig skin sensitization test.

Executive summary:

A sample of dicyclopentadiene novolac epoxide was submitted to the Acute Toxicology Laboratory of Health and Environmental Sciences-Texas, for assessment of skin sensitization potential. Source of this solid brown material was Resins Research, Freeport, Texas.

Dicyclopentadiene novalac epoxide is not likely to be a potent human skin sensitizer, based on results of the guinea pig skin sensitization test. None of the 10 guinea pigs exposed to a 5% solution of the test material in DOWANOL* PM glycol ether product: Tween 80 surfactant (9:1) exhibited signs of sensitization. Under similar conditions, 10 of 10 guinea pigs exposed

to a known mild sensitizer (diglycidyl ether of bisphenol A) used as a positive control showed significant signs of sensitization.