Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to a standard method but was non-GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Principles of method if other than guideline:
The guinea pig sensitization method used was a modification of the method of Maguire (1973): The Bioassay of Contact Allergens in the Guinea pig. J. Soc. Cosmetic Chem. 24, 151-162.
GLP compliance:
no
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 1, 2 butylene oxide
- Physical state: Clear liquid
- Source: Inorganic Chemicals Laboratory, Midland, Michigan

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 (Charles River Breeding Laboratories, Inc., Kingston, 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 commercial certified laboratory chow (Ralston Purina Company, St. Louis, Missouri) and tap water -ad libitum. All animals were acclimated to the laboratory environment at least one week prior to testing and were housed 5 per cage. Each animal was identified by a numbered metal eartag.

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.1 ml of undiluted test material
Challengeopen allclose all
Route:
epicutaneous, open
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.1 ml of undiluted test material
No. of animals per dose:
10/dose
Details on study design:
The guinea pig sensitization method used was a modification of the method of Maguire (1973). The test material was applied undiluted. Ten
guinea pigs received 4 applications of the test material within 7 days during the insult phase of testing. An additional group of 10 guinea pigs received DER* 331 epoxy resin as a 10% solution in DOWANOL DPM/ Tween 80 ( 9: 1). The epoxy resin is known to be a skin sensitizer and served as a positive control. Each insult application consisted of 0.1 ml of the test material or the positive control resin applied to a gauze square patch, placed on the back of the guinea pig, then secured and covered with adhesive tape. Thefirst insult application was allowed to remain in place for 48 hours, then removed, and a second application of 0.1 ml was made. At the time of the third application, a total of 0.2 ml of Freund's Adjuvant, (Bacto-Adjuvant complete, H37RA DIFCO Laboratories, Detroit, Michigan) was. injected intradermally adjacent to the insult site. Forty-eight hours aafter this application,
the patch was removed and a fresh patch of 0.1 ml of the material was applied. The last patch was removed 48 hours later and the animals
allowed to rest for two weeks. Each time the insult patches were removed, observations for primary irritation effects were made and
recorded. After a two-week rest period, both flanks of the animal were clipped and challenged with the test solution on one side and if diluted, the appropriate solvent on the other. The challenge applications were not covered. Skin response at these sites was recorded at 24 and 48 hours after application.
Positive control substance(s):
yes
Remarks:
DER 331 epoxy resin

Results and discussion

Positive control results:
A positive response indicative of sensitization (slight to moderate redness) was observed on 9 of 10 guinea pigs receiving DER 331.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
0.1 ml
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1 ml. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
0.1 ml
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.1 ml. No with. + reactions: 0.0. Total no. in groups: 10.0.

Any other information on results incl. tables

None of the 10 guinea pigs treated with the undiluted test material revealed signs of sensitization. Therefore, this material was not considered a potential human skin sensitizer.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
The test material was not considered a potential human sensitizer.