Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

 


 

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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)
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
July 17, 1992
Deviations:
no
GLP compliance:
yes (incl. QA statement)
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.
Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
conditions:
- 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
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:

0.5 g, applied as a paste at 50% (w/w)
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
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.
Key result
Reading:
1st reading
Hours after challenge:
30
Group:
test chemical
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 chemical
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.

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

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.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:






















In a skin sensitisation assay (Bühler test: 95-0258-DGT), 20 female Guinea pigs received three dermal doses (day 0, 7 and 14) of 0.5 g 4-Hydroxy-TEMPO as a paste in petrolatum at a 50 % (w/w) concentration onto their left caudal flank, while nine female negative control animals received the vehicle alone. The maximum concentration feasible was determined in a pre-test. The animals were challenged on day 28, using the same vehicle and test item concentration, applied onto the right flank. No signs of skin sensitisation where detected. The latest positive control using 2-Mercaptobenzothiazol was positive. The study was performed according to GLP and it satisfies the requirements of OECD test guideline 406. The study is considered acceptable (key study).


























Migrated from Short description of key information:
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.

Justification for selection of skin sensitisation endpoint:
Adequate assay to address endpoint

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

The test item has no structural alert indicative for respiratory sensitisation. In addition, no human data on respiratory sensitisation have been reported. The test item is considered not to induce respiratory sensitisation.



Migrated from Short description of key information:
Considered not to induce respiratory sensitisation.

Justification for classification or non-classification

Skin sensitisation


Based on the results of an in vivo skin sensitisation test, the test item should not be classified with regard to skin sensitisation according to Directive 67/548/EEC and Regulation (EC) No 1272/2008 (GHS, CLP).


 


Respiratory sensitisation


Considered not to induce respiratory sensitisation.