Registration Dossier

Administrative data

Description of key information

Substance is not irritating to skin.

Substance is not irritating to eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
according to
Guideline:
other: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, Division of Pharmacology, FDA, Hautgiftigkeit nach Draize (1959)
Deviations:
not specified
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
8
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: after 24h and after 72h; mean value is determined
Score:
0
Max. score:
0
Reversibility:
other: not applicable, no irritation occured
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: FDA
Conclusions:
The test item has not to be classified as "irritant".
Executive summary:

The test item has not to be classified as "irritant".

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
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
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Elevage de Gerome (Quartier Labaste - F40260 Linxe)
- Age at study initiation: 11 weeks
- Weight at study initiation: 2.31 kg to 2.48 kg.
- Housing: individual box instalIed in conventional air conditioned animal husbanding
- Diet (e.g. ad libitum): ad lib.
- Water (e.g. ad libitum): ad lib.
- Acclimation period: minimal 5-day acclimatisation period

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C to 22°C
- Humidity (%): 40% to 57%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
other: one eye of each animal served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g of the test item was instilIed as supplied
- Concentration (if solution): n.a.

VEHICLE
- Amount(s) applied (volume or weight with unit): n.a.
- Concentration (if solution): n.a.
- Lot/batch no. (if required): n.a.
- Purity: n.a.
Duration of treatment / exposure:
single treatment
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: n.a.

SCORING SYSTEM:
evaluated:
CHEMOSIS (A)
DISCHARGE (B)
REDNESS (C)
IRIS (D)
CORNEA: DEGREE OF OPACITY (E)
CORNEA: EXTENT OF OPACITY (F)


TOOL USED TO ASSESS SCORE: visual
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: Examination after 1, 24, 48 and 72 hours after application of the test item
Score:
0.3
Max. score:
0.3
Reversibility:
fully reversible

INDIVIDUAL AND MEAN SCORES OF CONJUNCTIVAE, IRIS AND CORNEA:

 Animal n°    Time after treatment    CONJUNCTIVAE    IRIS    CORNEA  
     CHEMOSIS (A)    REDNESS (C)    LESION (D)    OPACITY(E)  
 A8758    24 hours   0 1 0 0
   48 hours   0 0 0 0
   72 hours   0 0 0 0
 TOTAL   0 1 0 0
 Mean   0 0,3 0 0
 A8760    24 hours   0 1 0 0
   48 hours   0 0 0 0
   72 hours   0 0 0 0
 TOTAL   0 1 0 0
Mean 0 0,3 0 0
 A8761    24 hours   0 1 0 0
   48 hours   0 0 0 0
   72 hours   0 0 0 0
 TOTAL   0 1 0 0
 Mean   0 0,3 0 0
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In conclusion, the results obtained, under these experimental conditions, enable to conclude that the
test item N,N'-hexane-I,6-diylbis(hexahydro-2-oxo-1H-azepine-1-carboxamide) needs not to be
classified according to the criteria for the classification, packaging and labelling of dangerous
substances in compliance with the E.E.C Directives n° 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 2. No signal word and hazard statement are required.
Executive summary:

The ocular conjunetivae reactions observed during the study have been slight and totally reversible

in the three animals: a slight redness, noted 1 hour and 24 hours after the test item instillation,

associated with a slight chemosis only noted 1 hour after the test item instillation.

In conclusion, the results obtained, under these experimental conditions, enable to conclude that the

test item N,N'-hexane-I,6-diylbis(hexahydro-2-oxo-1H-azepine-1-carboxamide) needs not to be

classified according to the criteria for the classification, packaging and labelling of dangerous

substances in compliance with the E.E.C Directives n° 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 2. No signal word and hazard statement are required.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for selection of skin irritation / corrosion endpoint:
Only study available

Justification for selection of eye irritation endpoint:
Study is assessed with the highest reliability amongst the studies on the subject "eye irritation"

Justification for classification or non-classification

The substance has neither to be classified into the hazard class "skin corrosion / irritation" nor the hazard class "serious eye damage / eye irritation".