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Description of key information

A guinea pig maximization test was conducted. None of the 10 guinea pigs treated with the undiluted test substance revealed signs of sensitization.

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
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
Justification for non-LLNA method:
The test was performed before the OECD guideline 429 (LLNA) entered into force.
Species:
guinea pig
Strain:
Hartley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc., Kingston, New York
- Age at study initiation: no data
- Weight at study initiation: no data
- Housing: housed 5 per cage
- Diet: ad libitum, commercial certified laboratory chow (Ralston Purina Company, St. Louis, Missouri)
- Water: ad libitum, tap water
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.1 mL undiluted test material
Day(s)/duration:
14 days
Adequacy of induction:
not specified
Route:
epicutaneous, open
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.1 mL undiluted test material
Day(s)/duration:
48 hours
Adequacy of challenge:
not specified
No. of animals per dose:
10/dose
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 4
- Exposure period: 7 days
- Test groups: 0.1 mL
- Control group: not included
- Site: back

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. The first 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 after 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.

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge:
- Exposure period: 48 hours
- Test groups: 0.1 mL
- Control group: not included
- Site: flanks
- Evaluation (hr after challenge): 24 and 48

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
Positive control results:
A positive response indicative of sensitization (slight to moderate redness) was observed on 9 of 10 guinea pigs receiving DER 331.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.1 mL
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.1 mL
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
positive control
Dose level:
10%
No. with + reactions:
9
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation
Reading:
1st reading
Group:
negative control
Remarks on result:
not measured/tested

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.

Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

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. The first 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 after 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. A positive response indicative of sensitization (slight to moderate redness) was observed in 9 of 10 guinea pigs receiving the positive control. None of the 10 guinea pigs treated with the undiluted test substance revealed signs of sensitization. Therefore, the test substance is not considered a skin sensitizer (Dow, 1984)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008


The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data the test item is not classified for skin sensitization according to Regulation (EC) No 1272/2008 (CLP).