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Diss Factsheets

Administrative data

Description of key information

The test substance was demonstrated to be not sensitising to the skin in a key, reliable Delayed contact hypersensitivity study in guinea pigs.

An in vitro or in chemico skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study (initiated before October 2016) is available.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

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

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.

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.
Endpoint:
skin sensitisation: in vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Skin sensitisation in vivo:

A Delayed Contact Hypersensitivity study was performed according to OECD guideline 406. The test material induced and challenged at 1% concentration did not cause delayed contact hypersensitivity in guinea pigs.

Skin sensitisation in vitro:

An in vitro or in chemico skin sensitisation does not need to be conducted because adequate data from an in vivo skin sensitisation study (initiated before October 2016) is available.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available data and the criteria laid down in the CLP Regulation (EC) 1272/2008, the substance is not to be classified as skin sensitizer.