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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Non-GLP, near guideline study, available as unpublished report, no restrictions, fully adequate for assessment.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
no
Type of study:
guinea pig maximisation test
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: commercial supplier (Porcellus Ltd., UK)
- Weight at study initiation: 623 g (males) and 571 g (females)
- Housing: hanging stainless-steel cages with all-mesh floors and tops and half-mesh fronts, each cage measured 54 cm x 31 cm x 36 cm
- Diet: SGl with vitamin C supplement, Grain Harvesters Ltd., Kent, ad libitum
- Water: ad libitum
- Acclimation period: at least two weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Photoperiod (hrs dark / hrs light): 12 /12
Route:
intradermal and epicutaneous
Vehicle:
other: Intradermal induction: corn oil; Epicutaneous induction and challange: petroleum jelly
Concentration / amount:
Induction:
Intradermal injection; 0.5% (m/v) in corn oil
Topical application; 50% (m/m) in petroleum jelly

Challenge:
Topical challange: 50% (m/m) in petroleum jelly
Route:
epicutaneous, occlusive
Vehicle:
other: Intradermal induction: corn oil; Epicutaneous induction and challange: petroleum jelly
Concentration / amount:
Induction:
Intradermal injection; 0.5% (m/v) in corn oil
Topical application; 50% (m/m) in petroleum jelly

Challenge:
Topical challange: 50% (m/m) in petroleum jelly
No. of animals per dose:
Main test: ten males and ten females
Control group: five males and five females
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
The animals were closely shorn in the shoulder region using electric clippers followed by an electric razor; two rows of three injections were made, one on each side of the midline, as follows:

Test animals:
two injections (0.1 ml) of Freund's complete adjuvant (FCA)
two injections (0.1 ml) of the test material in solvent (corn oil)
two injections (0.1 ml) of the test material in 50:50 FCA/solvent (corn oil)

Control animals:
two injections (0.1 ml) of Freund's complete adjuvant (FCA)
two injections (0.1 ml) of solvent (corn oil)
two injections (0.1 ml) of 50:50 FCA/solvent (corn oil)

One week after induction by the intradermal injections, the same area of skin was shaved using electric clippers only. A 4 cm x 4 cm patch of Whatman Number 3 filter paper was coated with 0.45 ml of the test substance in petroleum jelly, placed over the site of injection and covered with a 'Sleek' dressing. The dressing was then securely covered with an 8 cm 'Poroplast' elastic adhesive bandage for 48 hours. Similar patches of filter paper (but moistened with the corn oil or petroleum jelly, as appropriate) were applied to the controls.

B. CHALLENGE EXPOSURE
Topical challenge was carried out two weeks after the topical induction. Hair was removed from a 3 cm x 3 cm area of one flank by clipping then shaving. A 2 cm x 2 cm patch of Whatman Number 3 filter paper moistened with 0.15 ml of the test substance in petroleum jelly was placed over the shaved area and covered with a 3 cm square of adhesive tape ('Blenderm') held in place by an 8 cm 'Poroplast' elastic adhesive bandage. Controls were also treated with the diluted test material. After 24 hours the patch was removed and the site examined for a response immediately, 24 and 48 hours after its removal.
Positive control substance(s):
no
Reading:
other: immediate after challenge
Hours after challenge:
0
Group:
test chemical
Dose level:
50%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: other: immediate after challenge. . Hours after challenge: 0.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
other: 24 hours after challenge
Hours after challenge:
24
Group:
test chemical
Dose level:
50%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: other: 24 hours after challenge. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
other: 48 hours after challenge
Hours after challenge:
48
Group:
test chemical
Dose level:
50%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: other: 48 hours after challenge. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
other: immediate after challenge
Hours after challenge:
0
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: other: immediate after challenge. . Hours after challenge: 0.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
other: 24 hours after challenge
Hours after challenge:
24
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: other: 24 hours after challenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
other: 48 hours after challenge
Hours after challenge:
48
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: other: 48 hours after challenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of the study, the test item has not to be classified as skin sensitizer.
Executive summary:

The skin sensitisation potential of 2,6-difluorobenzamide was assessed in a maximisation test comparable to OECD guideline 406 (Sittingbourne Research Centre, 1987). In this study, guinea pigs (Dunkin-Hartley, 10/sex) were induced by intradermal injection (0.5% m/v in corn oil) and, one week later, by epicutaneous application (50% m/m in petroleum jelly). Two weeks after induction by epicutaneous application, the animals were challenged by epicutaneous application (50% m/m in petroleum jelly) for 24 hours. The response was scored immediately after removal of the patch and after 24 and 48 hours after patch removal. None of the animals showed positive reactions. The test material was therefore concluded not to be a skin sensitiser in guinea pigs.

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

The skin sensitisation potential of 2,6-difluorobenzamide was assessed in a maximisation test comparable to OECD guideline 406 (Sittingbourne Research Centre, 1987). In this study, guinea pigs (Dunkin-Hartley, 10/sex) were induced by intradermal injection (0.5% m/v in corn oil) and, one week later, by epicutaneous application (50% m/m in petroleum jelly). Two weeks after induction by epicutaneous application, the animals were challenged by epicutaneous application (50% m/m in petroleum jelly) for 24 hours. The response was scored immediately after removal of the patch and after 24 and 48 hours after patch removal. None of the animals showed positive reactions. The test material was therefore concluded not to be a skin sensitiser in guinea pigs.


Migrated from Short description of key information:
No skin sensitisation potential was reported in guinea pigs upon intradermal (concentration: 0.5%) and epicutaneous (concentration: 50%) induction followed by epicutaneous challenge (concentration: 50%) with 2,6-difluorobenzamide in a guinea pig maximisation test.

Justification for selection of skin sensitisation endpoint:
Most reliable study.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for skin sensitization under Directive 67/548/EEC, as amended for the 31st time in Directive2009/2/EC.

 

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for skin sensitization under Regulation (EC) No 1272/2008, as amended for the fifth time in Directive EC 944/2013.