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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:
20 August 1991 - 26 September 1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP study similar to OECD 406 Buehler method but with fewer animals

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
The room temperature was slightly below the range specified in the protocol, but was not expected to adversely affect the health of the animals.
GLP compliance:
yes (incl. certificate)
Type of study:
Buehler test

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Details on test animals and environmental conditions:
Temperature: 67-76 degrees F; Relative hunmidity: 48-85%; Light: 12 hour light/dark cycle; Diet: Purina Ginea Pig Chow #5026 and tap water provided ad libitum; Caging: Individual suspended wire mesh

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: Acetone in the challenge phase
Concentration / amount:
100% of the test substance in the induction phase and 50% w/v in acetone in the challenge phase. 0.25% w/v dinitrochlorobenzene (DNCB) positive control in 80% ethanol in the induction phase and 0.1% in 80%ethanol in the challenge phase.
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: Acetone in the challenge phase
Concentration / amount:
100% of the test substance in the induction phase and 50% w/v in acetone in the challenge phase. 0.25% w/v dinitrochlorobenzene (DNCB) positive control in 80% ethanol in the induction phase and 0.1% in 80%ethanol in the challenge phase.
No. of animals per dose:
Test material: 6/sex; Positive control: 3/sex; Naive controls: 3/sex
Details on study design:
Following a preliminary irritation phase to determine the irritation threshold, the test substance and positive control groups were administered 0.4 ml/site one time per week for three weeks for a total of three induction exposures. Following a two week rest period, the respective groups were challenged with the the test substance and positive control DNCB. A naive control group also was included in the challenge phase. One week following the challenge phase, the test and naive control groups were rechallenged with the test substance. In all phases sites were scored at 24 and 48 hours.
Challenge controls:
A naive control and positive control were included in the challenge phase.
Positive control substance(s):
yes
Remarks:
dinitrochlorobenzene

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
50%
No. with + reactions:
1
Total no. in group:
12
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 1.0. Total no. in groups: 12.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
50%
No. with + reactions:
0
Total no. in group:
12
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 12.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50% test material
No. with + reactions:
0
Total no. in group:
12
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50% test material. No with. + reactions: 0.0. Total no. in groups: 12.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50% test material
No. with + reactions:
0
Total no. in group:
12
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50% test material. No with. + reactions: 0.0. Total no. in groups: 12.0.
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.1%
No. with + reactions:
5
Total no. in group:
6
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.1%. No with. + reactions: 5.0. Total no. in groups: 6.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
0.1%
No. with + reactions:
5
Total no. in group:
6
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 0.1%. No with. + reactions: 5.0. Total no. in groups: 6.0.
Reading:
1st reading
Hours after challenge:
24
Group:
other: test group rechallenge
Dose level:
50%
No. with + reactions:
2
Total no. in group:
12
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: test group rechallenge. Dose level: 50%. No with. + reactions: 2.0. Total no. in groups: 12.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
other: test group rechallenge
Dose level:
50%
No. with + reactions:
1
Total no. in group:
12
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: test group rechallenge. Dose level: 50%. No with. + reactions: 1.0. Total no. in groups: 12.0.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In accordance with EU CLP Regulation No. 1272/2008, classiification as a sensitizer is required for this substance.
Executive summary:

The skin sensitation potential of the test substance was evaluated in guinea pigs using a method similar to the OECD 406 Buehler method. Following a preliminary irritation phase to determine the irritation threshold, the undiluted test substance (100%) and 0.25% w/v positive control (dinitrochlorobenzene, DNCB) was administered at a dose of 0.4 ml/site to groups of guinea pigs (6/sex for the test substance and 3/sex for the controls) one time per week for three weeks for a total of three induction exposures. Following a two week rest period, the respective groups were challenged with the the test substance (50% in acetone) and positive control DNCB (0.1% in 80% ethanol). A naive control group also was included in the challenge phase. One week following the challenge phase, the test and naive control groups were rechallenged with the test substance (50% in acetone). In the challenge phase one of 12 animals in the test group exhibited a positive score of 1 at 24 hours; no positive scores were noted at 48 hours. Positive responses of 1 also occurred in the rechallenge phase at 24 hours (2/12) and at 48 hours (1/12). Based on these results, the test substance was considered a weak sensitizer. In accordance with EU CLP Regulation No. 1272/2008, classiification as a sensitizer is required for this substance.