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Diss Factsheets

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:
1990-04-09 to 1990-05-09
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Remarks:
Study is GLP compliant and equivalent or similar to EU and OECD Guidelines. The highest non-irritating dose was used as opposed to a dose that causes mild to moderate irritation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Version / remarks:
Annex V (Buehler)
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes (incl. QA statement)
Type of study:
Buehler test
Justification for non-LLNA method:
The skin sensitisation potential of the test substance was investigated in an in vivo study in guinea pigs. The study was performed, prior to the date where Local Lymph Node Assay (LLNA) was considered a the default assay.

Test material

Constituent 1
Test material form:
liquid
Specific details on test material used for the study:
- Name of test material (as cited in study report): 6398-16-20
- Physical state: clear, pale yellow liquid
- Stability under test conditions: There was no apparent change in the physical state of the test article during administration
- Other: The purity, identity, strength and stability of the test article were the responsibility of the sponsor.

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: BuckberG Lab Animals, Tomkins Cove, New York
- Weight at study initiation: 300 - 500 g
- Housing: Individually in 1/2" wire mesh cages
- Diet: Purina Guinea Pig DietR, ad libitum
- Water: Fresh tap water, at libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
other:
Vehicle:
other: 80% ethanol
Concentration / amount:
Concentration of test material and vehicle used at induction:
1% in 80% aqueous ethanol for each of three inductions

Concentration of test material and vehicle used for each challenge:
1% in 80% aqueous ethanol
Challengeopen allclose all
Route:
other: dermal
Vehicle:
other: 80% ethanol
Concentration / amount:
Concentration of test material and vehicle used at induction:
1% in 80% aqueous ethanol for each of three inductions

Concentration of test material and vehicle used for each challenge:
1% in 80% aqueous ethanol
No. of animals per dose:
Number of animals in dose-range-finding test: 4
Number of animals in test group: 20
Number of animals in negative control group: 10
Number of animals in positive control group: 5
Details on study design:
RANGE FINDING TESTS:
Four animals (2 male, 2 female) were each exposed to four different concentrations of the test article to determine the highest non-irritating dose. In this test, both sides of the animal were shaved and exposed to 4 concentrations of the material. The highest non-irritating concentration was that concentration in vehicle that induced responses not exceeding two + and two 0 grades in the group of four animals. Based upon the results of this study and in discussion with the sponsor, the dose chosen for induction and challenge was 1.0%.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Test groups: Male and female, 1% in 80% ethanol
- Control group: Positive control and vehicle control
- Site: Left shoulder
- Frequency of applications: Once a week
- Duration: 3 weeks
- Concentrations: 1% in 80% enthanol

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 14 days after last induction exposure
- Exposure period: 6 hours
- Test groups: Male and female, 1% in 80% ethanol
- Control group: Positive control, vehicle control, and challenge control
- Site: Shoulder on opposite side of induction exposure
- Concentrations: 1% in 80% ethanol
- Evaluation (hr after challenge): 24 and 48 hours
Challenge controls:
The test material was used in the vehicle control animals during the challenge exposure.
Positive control substance(s):
yes
Remarks:
1-Chloro-2,4-dinitrobenzene (DNCB)

Results and discussion

Positive control results:
A positive response was elicited in the animals receiving the positive control substance.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
1 %
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
Severity = 0.1
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
80 % Ethanol
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
Severity = 0.0
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
1% 6398-16-20
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
Severity = 0.2
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.3 % DNCB
No. with + reactions:
4
Total no. in group:
4
Clinical observations:
Severity = 3.0
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
1 %
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
Severity = 0.1
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
80 % Ethanol
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
Severity = 0.0
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
1% 6398-16-20
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
Severity = 0.0
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
0.3 % DNCB
No. with + reactions:
4
Total no. in group:
4
Clinical observations:
Severity =3.0

Any other information on results incl. tables

Maximum concentration not causing irritating effects in preliminary test: 1 %  

Signs of irritation during induction: Slight-moderate patchy erythema was seen after each induction dose in 4 -7 animals.  

Evidence of sensitisation of each challenge concentration: No evidence of sensitization was observed in test and control animals.  

Other observations: All skin reactions noted after challenge were slight patchy erythema.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the observations made in this study, the test material induced and challenged at 1% concentration did not cause delayed contact hypersensitivity in guinea pigs.