Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Remarks:
This study has been performed before REACH and the limitations for in-vivo testing of sensitization came into force.
Type of information:
experimental study
Adequacy of study:
key study
Study period:
14 January to 14 February 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Performed under GLP
Justification for type of information:
The type of method is one of the officially accepted animal test methods for skin sensitisation.
Qualifier:
according to
Guideline:
EPA OPP 81-6 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
This study has been performed before REACH and the limitations for in-vivo testing of sensitization came into force.
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL- Source: International Specialty Products - Name: Suttocide® A (Powder) - Batch of test material: 01/13/97 - Appearance: White powder - Purity test date: Not specified.- Storage: The test article was stored at room temperature and humidity. - Use in test: The test article was used as received and moistened with 0.1 ml of distilled water prior to dosing.
Species:
guinea pig
Strain:
Hartley
Remarks:
Albino
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS- Source: Ace Animals, Boyertown, PA on 1/07/97- Age at study initiation: born the week of 12/13/96- ID: identified by cage notation and a uniquely numbered metal eartag- Weight at study initiation: 289-351 g- Housing: 1/cage in suspended wire cages- Diet: Fresh Purina Guinea Pig Chow (Diet #5025) ad libitum- Water: ad libitum: ENVIRONMENTAL CONDITIONS- Temperature (°C): controlled- 12 hour light/dark cycle
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
0.4 g, of the test article (moistened with 0.1 ml of distilled water
Day(s)/duration:
Once a week on the same day each week for a three week period, a total of 3 six hour insults.
Adequacy of induction:
highest technically applicable concentration used
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
0.4 g, of the test article (moistened with 0.1 ml of distilled water).
Day(s)/duration:
6-hour exposure, fourteen days after the last induction exposure
Adequacy of challenge:
highest non-irritant concentration
No.:
#2
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
0.4 g, of the test article (moistened with 0.1 ml of distilled water).
Day(s)/duration:
6-hour exposure
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
10
Details on study design:
MAIN STUDY A. INDUCTION EXPOSURE - Exposure period: 6 hours - No. of exposures: 3, once/week on the same day each week for a three week period, a total of 3 six hour insults - Test group (#1): 100% - Control group (#2): Naive control - Site: the left shoulder area using a 25 mm Hilltop Chamber which is designed to keep the test article on a 25 mm area of the site - Occlusion: The chamber was covered with a 8 x 8 cm piece of rubber dental dam and wrapped with non-irritating tape to provide occlusion. After 6 hours, the dams were removed. Any residual test article was cleansed from the sites with distilled water and the sites were dried with soft toweling. - Evaluation (h after induction): 24 and 48 B. CHALLENGE EXPOSURE - No. of exposures: 1 - Time point of challenge: Fourteen days after the last induction exposure - Exposure period: 6 hours - Test group (#1): 100% - Control group (#2): 100% - Site: on the left hip area - Evaluation (h after challenge): 24, 48 and 72 OTHERThe animals in groups 1 and 2 were observed once daily for the duration of the study for mortality, toxicity and pharmacological effects. Body weights were recorded pretest, the day following the last induction application and the day following the challenge application.
Challenge controls:
Five animals were untreated for the three week induction period and served as the naive control.
Positive control substance(s):
yes
Remarks:
2,4-Dinitrochlorobenzene: induction with 0.4 ml of 0.2% and challenge with 0.4 ml of 0.1%
Positive control results:
Dinitrochlorobenzene (DNCB) is a sensitizer, with a maximum of 7 out of 10 animals responding.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
test group
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
One animal had diarrhea and one animal had a prolapsed rectum during the observation period. Body weight changes were normal.
Interpretation of results:
GHS criteria not met
Conclusions:
The test article is not a dermal sensitizer.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The study performed in 1984 that indicated that the substance had significant potential for sensitiztion was not reliable as methods applied were out-dated. Further, the sample tested was not the commercially available Suttocide A, and thus it was recommended that further studies applying the Buehler method should be performed on the commercially available material to assess the true potential of Suttocide A to produce contact allergy under conditions which more closely simulate potential human exposure, i.e., via repeated topical application. Such a study was performed at MB Research Laboratories in 1997 and showed instead that sodium n-(hydroxymethyl)glycinate is not a dermal sensitizer.


Migrated from Short description of key information:
The test article is not a dermal sensitizer as it did not induce any significant response in the Buehler test.

Justification for selection of skin sensitisation endpoint:
GLP study according to an internationally accepted guideline

Justification for classification or non-classification

As the results of the key study did not fulfill the criteria for classification according to CLP, the substance is not classified for sensitization.