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)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
August 24, 2016 to September 23, 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2600 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
This study was originally comissioned for R&D purposes. Therefore, in the interest of animal welfare it was considered scientificaly unjustified to run the same study to the LLNA guideline.
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male
Details on test animals and environmental conditions:
Prior to use, all animals were acclimated for at least five days. Animals were individually housed in wire mesh suspension cages. The animals were maintained according to the recommendations contained in the National Academy Press 2011: ' Guide for the Care and Use of Laboratory Animals.' The animals were supplied Purina Guinea Pig Chow and tap water ad libitum during both acclimation and test periods.

ENVIRONMENTAL CONDITIONS:
Light/dark cycle: 12 hour light, 12 hour dark cycle
Temperature: 64 - 79 F
Relative Humidity - 30-70 %
Route:
epicutaneous, occlusive
Vehicle:
other: Mineral Oil
Concentration / amount:
10 %
Day(s)/duration:
Weekly application for a total of 3 weeks
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Route:
epicutaneous, occlusive
Vehicle:
other: Mineral Oil
Concentration / amount:
5%
Day(s)/duration:
Once
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
20
Details on study design:
The test substance was evaluated for sensitization potential by applying 0.4 mL at a 10% concentration directly into Hilltop Chambers and applying them to the slipped left shoulder of twenty albino guinea pigs in the following manner: The animals were held gently, and the chambers were applied as quickly as possible to the clipped left shoulder. The chambers were secured with Micropore tape and further secured with Kendall adhesive tape. Approximatley 6 hours later, the tape and chambers were removed. Two additional induction doses were conducted following the same procedure, at weekly intervals.

Two weeks after the final application the animals received a topical primary challenge dose (6 hours contact) of the test subtance at a 5% concentration, on a naive site located on the right shoulder. Animals were scored for irritation at 24 and 48 hours after initiation of the primary challenge application/
Challenge controls:
Ten guinea pigs served as a naive control group, and remained untreated through the induction phase. Six naive animals recived only the primary challlenge dose, at a 5% concentration. The four remaining guinea pigs were designated for re-challenge, if necessary
Positive control substance(s):
yes
Remarks:
1-chloro-2,4-Dinitrobenzene
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
5%
No. with + reactions:
1
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
5%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
5%
No. with + reactions:
0
Total no. in group:
6
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
5%
No. with + reactions:
0
Total no. in group:
6
Remarks on result:
no indication of skin sensitisation
Group:
positive control
Remarks on result:
not measured/tested
Interpretation of results:
GHS criteria not met
Conclusions:
Based on the results of this study, the GHS criteria for skin sensitization are not met
Executive summary:

The test substance was evaluated for sensitization potential by applying 0.4 mL at a 10% concentration directly into Hilltop Chambers and applying them to the clipped left shoulder of twenty albino guinea pigs in the following manner: The animals were held gently, and the chambers were applied as quickly as possible to the clipped left shoulder. The chambers were secured with Micropore tape and further secured with Kendall adhesive tape. Approximatley six hours later, the tape and chambers were removed. Two additional induction doses were conducted following the same procedure.

Two weeks after the final application the animals received a topical primary challenge dose ( 6 hours contact) of the test substance at 5% concentration, on a naive control site located on the right shoulder. Animals were scored for irritation at 24 and 48 hurs after initiation of the primary challenge application.

Ten guinea pigs served as a naive control group, and remained untreated through the induction phase. Six naive control animals received only the primaru challenge dose, at a 5% concentration. The four remaining guinea pigs were designated for a re-challenge, if necessary.

Following primary challenge of the test susbtance at 5% concentration, the incidence of grade 1 response or greater in the test group (1 of 20) was compared to that of the naive control group (0 of 6). The incidence and severity of these responses were not significantly greater than those produced by the naive control group indicating that sensitization had not been induced.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

The potential of the test substance to be a contact sensitizer was investigated in a study conducted in accordance with standardised guideline OECD 406. It was assigned a reliability score of 1 in accordance with the criteria detailed by Klimisch (1997)

The test substance was evalutated for sensitization potential by applying 0.4 mL at a 10% concentration directly into Hilltop Chambers and applying them to the clipped left shoulder of twenty albino guinea pigs. Approximatley 6 hours later, the tape and chambers were removed. Two additional inductions doses were conducted following the same procedure, at weekly intervals.

Two weeks after the final application the animals received a topical primary challenge dose of the test substance at 5% concentration, on a naive site located on the right shoulder. Animals were scored for irritation at 24 and 48 hours after initiation of the primary challenge application

Following primary challenge, the incidence of grade 1 response or greater in the test group (1 of 20) was compared to that of the naive contril group (0 of 6). The incidence and severity of these responses were not significantly greater than those produced by the naive control group indicating that sensitization had not been induced.

Justification for classification or non-classification

In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No. 1272/2008, the test material does not require classification for skin sensitzation.