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Administrative data

Description of key information

A study was performed according to OECD guideline 429 to assess the skin sensitization potential of the test item in the CBA/Ca strain mouse following topical application to the dorsal surface of the ear.

The test item was considered to be a sensitizer under the conditions of the test.

The test item was classified as a contact sensitizer (Category 1B) according to the Globally Harmonized System of Classification and Labelling of Chemicals.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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
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
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.
Route:
intradermal
Vehicle:
other: DOWANOL DPM glycol ether product: Tween 80 surfactant (9:1)
Concentration / amount:
5% solution of the test material
Route:
other: epicutaneous
Vehicle:
other: DOWANOL DPM glycol ether product: Tween 80 surfactant (9:1)
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)
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).
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..
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. .
Reading:
other: N/A
Group:
negative control
Remarks on result:
not measured/tested

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.

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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The test item was classified as a contact sensitizer (Category 1B) according to the Globally Harmonized System of Classification and Labelling of Chemicals, due to information available from a LLNA study.