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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:
1995-03-16 to 1995-07-18
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study (OECD 406)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
July 17, 1992
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of study:
Buehler test
Justification for non-LLNA method:
The non-LLNA study was performed in 1992 and adequately demonstrates no skin sensitising properties in the test substance. As this study meets the endpoint requirements, it was considered no necessary to perform a further in vivo study.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: flakes

In vivo test system

Test animals

Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Versuchstierzucht, Gartenstrasse 27, 33174 Borchen, Germany
- Age at study initiation: young adults
- Weight at study initiation: < 500 g
- Housing: conventional, groups of 5 at maximum in Macrolon cages type IV
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3°C
- Humidity:30 - 70 %
- Air changes: 15 per h
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: Main test from: 1995-05-01 to 1995-06-01

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
0.5 g, applied as a paste at 50% (w/w)
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
0.5 g, applied as a paste at 50% (w/w)
No. of animals per dose:
20
plus 9 for negative control (from n=10, one Guinea pig excluded from study during in life phase due to presumed pregnancy)
Details on study design:
RANGE FINDING PRE-TESTS:
- IN-LIFE dates: 1995-03-21 to 1995-03-24
- Concentrations: 0.5 g, applied as a paste at 2.5, 10 25 or 50% (w/w)
- No. of animals: 3

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 (day 0, 7, 14)
- Exposure period: 6 hrs each
- Site: left flank (sheared 2 to 3 hrs prior to application)
- Concentrations: 0.5 g, applied as a paste at 50% (w/w)

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: day 28
- Exposure period: 6 hrs
- Site: right caudal flank (sheared 2 to 3 hrs prior to application)
- Concentrations: 0.5 g, applied as a paste at 50% (w/w)
- Evaluation: 30 and 54 hrs after challenge

OTHER: Application sites were swiped with cotton pads soaked in corn oil 6 hrs after each application.
Challenge controls:
on apical flank of the same animals
Positive control substance(s):
no

Results and discussion

Positive control results:
Last in house test on this animal strain with 2-Mercaptobenzothiazol from 1994-11-07 to 1994-12-02, animals were sensitive to pos. control item.

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
30
Group:
test group
Dose level:
50%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none reported
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 30.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none reported.
Key result
Reading:
2nd reading
Hours after challenge:
54
Group:
test group
Dose level:
50%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none reported
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 54.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none reported.
Key result
Reading:
1st reading
Hours after challenge:
30
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
9
Clinical observations:
none reported
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 30.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 9.0. Clinical observations: none reported.
Key result
Reading:
2nd reading
Hours after challenge:
54
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
9
Clinical observations:
none reported
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 54.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 9.0. Clinical observations: none reported.

Any other information on results incl. tables

0 of 20 animals showed erythema or edema after induction and challenge, at either 30 or 54 hours post application.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance 4-Hydroxy TEMPO did not induce delayed contact hypersensitivity in the Bühler test and is thus not regarded as a skin sensitiser.