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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2nd August 2017 - 1st September 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2017

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
Study was initially conducted for R&D purposes. However, as a valid skin sensitization test already existed it was considered unethical to re-run the same study to a different method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- Appearance: yellow liquid
- Storage conditions of test material: Room temperature in the dark

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male
Details on test animals and environmental conditions:
Prior to use, all animals were acclimated for at least 5 days. Animals were individually housed in wire mesh suspension cages. The animals were maintained on a 12 hour cycle light controlled room, at a temperature of 64-79 F and a relative humidity of 30-70%

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, semiocclusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100%
Day(s)/duration:
six hours
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challengeopen allclose all
No.:
#1
Route:
epicutaneous, semiocclusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
75%
Day(s)/duration:
6 hours
Adequacy of challenge:
highest non-irritant concentration
No.:
#2
Route:
epicutaneous, semiocclusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
75%
Day(s)/duration:
6 hours
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
20
Details on study design:
0.4 ml of the test item at 100% concentration was added directly yo Hilltop chambers and applied to the clipped left shoulder of twenty albino guinea pigs. The chambers were secured in place with micropore and Kendall adhesive tape for 6 hours. Two additional 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 hour contact) of the test material at 75% concentration, on a naive site located on the right shoulder. Animals were scored for irritation at 24 and 48 houts are initation of the primary challenge application.
Challenge controls:
six naive control animals received only the primary challenge dose, at a concentration of 75%
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
75%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
75%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
75%
No. with + reactions:
0
Total no. in group:
6
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
75%
No. with + reactions:
0
Total no. in group:
6
Remarks on result:
no indication of skin sensitisation
Key result
Group:
positive control
Remarks on result:
not measured/tested

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Following primary challenge of the test article at 75% concentration, the incidence of grade 1 responses or greater in the test group (0 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.
Executive summary:

The test substance was evaluated for sensitization potential by applying 0.4 mL at a 100% concentration directly into Hilltop chmabers and applying them to the clipped left shoulder of twenty albino guinea pigs. The animals were held gently, and the chambers were applied as quickly as possible to the clipped left shoulder. The chmabers were secured with Micropore and Kendall adhesive tape. Approximatley 6 hours later, the tape and chambers were removed. Two additional indction doses were conducted following the same procedure, at weekly intervals.

Two weeks after the final application the animals received a topical primay challenge dose (6 hour contact) of the test material at 75% concentration, on a naive site located on the right shoulder. Animals were scored for irritation at 24 and 48 houts 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 primary challenge dose, at a 75% concentration. The four remaining guinea pigs were designated for a re-challenge, if necessary.

Follwoing primary challenge at 75% concentration, the incidene of grade 1 responses or greater in the test group (0 of 20) was compared to that of the naive control group (0 of 6). The incidence and severity of these resposnes were not significantly greater than those produced by the naive control group indicating that sensitization had not been induced.

Under the classification criteria set forth under GHS, the test substance is not considered to be a skin sensitizer.