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Diss Factsheets

Administrative data

Description of key information

Skin sensitisation: Negative

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:
2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2600 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Data from LLNA: BrdU-ELISA suggests weakly "positive" outcomes in the absence of QSAR flags for protein binding (OECD Toolbox) implying a false positive response. Confirmatory assay undertaken using the GPMT.
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River France
- Age at study initiation: 7 to 8 weeks
- Weight at study initiation: 382-487 g
- Housing: Up to 5 animals/cage noryl cages measuring 74.3 x 54.3 x 25 cm
- Diet (e.g. ad libitum): 8GP17 (Mucedola Srl) diet available ad libitum
- Water (e.g. ad libitum): tap water available ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 15
- Air changes (per hr): 15 - 20
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 2012-08-27 To: 2012-10-06
Route:
intradermal and epicutaneous
Vehicle:
corn oil
Concentration / amount:
- Concentrations used for induction: intradermal treatment: 0.5% in water; dermal treatment: 5 % in water
- Concentration in Freunds Complete Adjuvant (FCA): 0.5% test substance in a mixture of FCA and water (1:1)
- Concentrations used for challenge: 1 %
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
- Concentrations used for induction: intradermal treatment: 0.5% in water; dermal treatment: 5 % in water
- Concentration in Freunds Complete Adjuvant (FCA): 0.5% test substance in a mixture of FCA and water (1:1)
- Concentrations used for challenge: 1 %
No. of animals per dose:
test group: 20 animals
control group: 10 animals
Details on study design:
RANGE FINDING TESTS:
A dose range finding was performed in a preliminary study. 0.1 ml of test substance in water at various concentrations were injected intracutaneously into the skin of the scapula region. 24 hours and 7 days after application skin reaction was assessed.
For dermal applications various concentrations of the substance in water were applied on patches of 2x2 cm to the clipped skin. The patches were removed after 24 hours and dermal reactions were read immediately, 24 and 48 hours after patch removal.


MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: 1st exposure: intracutaneous injections (0.1 cm³); 2nd exposure: epicutaneous for 48 hours; evaluation after 24 hours each
- Concentration in Freunds Complete Adjuvants (FCA): test substance in vehicle at 0.5% concentration and in a mixture of FCA and vehicle (1:1)
- Test group: dermal: 5 % test substance in water (2 x 4 cm patch)
- Control group: vehicle (2 x 4 cm patch)
- Frequency of applications: day 1: intradermal treatment, day 8: dermal treatment
- Duration: 3 weeks


B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: on day 22
- Exposure period: dermal application for 24 hours
- Test groups: test substance (2 x 2 cm patch)
- Control group: test substance (2 x 2 cm patch)
- Site: left flanks
- Concentrations: 1 %
- Evaluation: 24 and 48 hours after removal of dressings
Challenge controls:
see above B. Challenge exposure
Positive control substance(s):
not specified
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
1 %
No. with + reactions:
0
Total no. in group:
9
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 1 %. No with. + reactions: 0.0. Total no. in groups: 9.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
1 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
1 %
No. with + reactions:
0
Total no. in group:
9
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 1 %. No with. + reactions: 0.0. Total no. in groups: 9.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
1 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Group:
positive control
Dose level:
n/a
Remarks on result:
not measured/tested
Interpretation of results:
GHS criteria not met
Conclusions:
Delayed dermal sensitisation has been investigated using the maximisation test according to OECD/EU test guidelines. The substance did not induce delayed dermal sensitisation in the guinea pig.
Executive summary:

Delayed dermal sensitisation has been investigated using the maximisation test according to OECD/EU test guidelines. The substance did not induce delayed dermal sensitisation in the guinea pig.

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

Justification for selection of skin sensitisation endpoint:

The potential for dermal sensitisation of the substance and a number of structural analogues has been evaluated using OECD test methods (OECD 442b - Skin sensitisation: Local lymph node assay: BrdU-ELISA). Treatment resulted in an increase in cell proliferation of draining lymph nodes in treated animals when compared to controls, indicating that these substances may elicit a sensitisation response in mice. It is possible that the specific LLNA method used is not suited to this class of substance (see also Kreiling et al. (2008) Food Chem Toxicol 46: 1896 -1904), QSAR (OECD Toolbox) giving no structural alerts for sensitisation arising from protein binding.

In addition there are, at present, no CLP criteria for predicting potency from the method used.

A confirmatory assay using the guinea pig maximisation test resulted in negative findings.


Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The available information indicate that the substance does not require classification as skin sensitising according to Regulation 1272/2008/EC (CLP) or Directive 67/548/EEC (DSD).