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Toxicological information

Eye irritation

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Administrative data

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

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

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-1 ,6-diylbis(hexahydro-2-oxo-1H-azepine-1-carboxamide)
- Lot/batch No.: 07112601
- Expiration date of the lot/batch: 26/11/2008
- Storage condition of test material: room temperature

Test animals / tissue source

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

Test system

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

Results and discussion

In vivo

Results
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

Any other information on results incl. tables

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

Applicant's summary and conclusion

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.