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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:
2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The guinea pig maximisation test was a generally accepted method at the time of the test conduction (2008).

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): N,N' -hexane-l ,6-diylbis(hexahydro-2-oxo-lH-azepine-l-carboxamide)
- Lot/batch No.: 07112601
- Expiration date of the lot/batch: 26 November 2008
- Storage condition of test material: Storage: room temperature

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River (F-69592 L' Arbresle)
- Age at study initiation: 4 weeks
- Weight at study initiation: 235 to 272 g
- Housing: The animals were housed either in groups of 2 or 3 in polycarbonate containers
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: minimum acclimatisation period of 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): between 19°C and 22°C
- Humidity (%): between 35% and 58%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
olive oil
Concentration / amount:
test item diluted at 50% and at 25% in liquid paraffin
Challengeopen allclose all
Route:
intradermal
Vehicle:
olive oil
Concentration / amount:
test item diluted at 50% and at 25% in liquid paraffin
No. of animals per dose:
negative control: 5
treated group: 10
Positive control substance(s):
yes
Remarks:
α-Hexylcinnamaldehyde

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
1st reading
Hours after challenge:
72
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
24
Group:
negative control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
50%
No. with + reactions:
2
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 2.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
50%
No. with + reactions:
1
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 1.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
72
Group:
test group
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 72.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
24
Group:
test group
Dose level:
25%
No. with + reactions:
2
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25%. No with. + reactions: 2.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
25%
No. with + reactions:
1
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 1.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
72
Group:
test group
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 10.0.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In view of these results, under these experimental conditions, the test item N,N'-hexane-1,6-
diylbis(hexahydro-2-oxo-1H-azepine-1-carboxamide) needs not to be classified, in accordance with
the criteria for classification, packaging and labelling of dangerous substances and preparations of the
E.E.C. Directives 67/548, 2001/59 and 99/45. No symbol and risk phrase are required.
In accordance with the Globally Harmonized System (COM(2007)355 final), the test item needs not to
be classified in category 1. No signal word and hazard statement are required.
Executive summary:

The aim of the study was to evaluate the possible allergenic activity ofthe test item N,N'-hexane-l,6 -

diylhis(hexahydro-2 -oxo-1H-azepine-l-carboxamide) after intradermic injection and topical

administration in guinea pigs.

After induction (intradermic injection at 10% and topical application at 50%) of 10 Guinea Pigs of

treated group with the test item N,N'-hexane-l,6 -diylbis(hexahydro-2 -oxo-1H-azepine-1 -carboxamide)

and a 10 -day rest phase, the challenge phase, under occlusive dressing for 24 hours,

consisted to a single topical application of the test item diluted at 50% and at 25% in liquid paraffin.

The experimental protocol was established according the OECD guideline No. 406 dated July 17th,

1992 and the method B.6 of the EEC No. 96/54 dated July 30th,1996.

It was recorded a slight to moderate erythema, in respectively 20% (2/10) and 10% (1 /10) of the

animals from the treated group, 24 and 48 hours after the challenge phase, on the treated areas at 50%

and 25%. These reactions were totally reversible at the reading time 72 hours.

No cutaneous intolerance reaction was recorded in animals from the negative control group.

In conclusion, in view of these results, under these experimental conditions, the test item N,N'hexane-

l,6 -diylbis(hexahydro-2 -oxo-1H-azepine-1 -carboxamide) needs not to be classified, in

accordance wilh the criteria for classification, packaging and labelling of dangerous substances and

preparations of the E.E.C Directives 67/548, 2001159 and 99/45. No symbol and risk phrase are

required.

In accordance with the Globally Harmonized System (COM(2007)355 final), the test item needs not to

be classified in category I. No signal word and hazard statement are required.