Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
QUALITY ASSURANCE ATTESTATION, G.L.P. COMPLIANCE STATEMENT & GLP certificates included in the full report. The study was conducted according to an internationally recognised method, and under GLP. No deviation was reported. The substance is adequately characterised. Therefore full validation applies.

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
2007
Report date:
2007

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
Methode B5
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
6,8-dimethylnon-7-enal
EC Number:
486-670-9
Cas Number:
899810-84-5
Molecular formula:
C11H20O
IUPAC Name:
6,8-dimethylnon-7-enal
Test material form:
other: liquid
Details on test material:
• Form : liquid
• Colour : colorless
• Batch n° : 862036
• Storage : room temperature
• Production date: September 2007 • Expiry date: September 2008
• Purity/Concentration: 97.79%

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Three female albino New Zealand rabbits were supplied by the Elevage de Gérome (Quartier Labaste
– F40260 Linxe). They were kept during a minimal 5-day acclimatisation period. During the test, the
animals weighed between 2.58 kg and 2.82 kg. At the beginning of the test, the animals were 12-week
old.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The second eye remained untreated serving as control.
Amount / concentration applied:
0.1 mL of the test item was instilled into the conjunctival sac of one eye. The other eye remained
untreated serving as control.
Duration of treatment / exposure:
72h
Observation period (in vivo):
Ocular examinations were performed on both right and left eyes 1 hour, 24, 48 and 72 hours following
treatment, according to the numerical evaluation given in the full report.
NOTE :
If no reaction is observed 72 hours after instillation, the study is terminated. In case of persistent reactions, additional
observations can be carried out from D4 to D21 in order to determine the reversible character of the lesions observed.
Number of animals or in vitro replicates:
3 females
Details on study design:
Each animal was kept in an individual box installed in conventional air conditioned animal
husbanding; the environmental conditions were:
- temperature : between 20°C and 23°C
- relative humidity : between 34% and 69%
- lighting time: 12 hours daily

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
ca. 2
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
ca. 1.3
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
ca. 1
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Max. score:
2
Remarks on result:
other: Max. duration: 72 h; Max. value at end of observation period: CA 2 (related to all animals)
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
ca. 1
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
ca. 1
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
ca. 0
Irritation parameter:
chemosis score
Max. score:
1
Remarks on result:
other: Max. duration: 72 h; Max. value at end of observation period: CA 1 (related to all animals)
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
ca. 0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
ca. 0.3
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
ca. 0
Irritation parameter:
cornea opacity score
Max. score:
1
Remarks on result:
other: Max. duration: 72 h; Max. value at end of observation period: CA 0 (related to all animals)
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
ca. 0
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
ca. 0
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
ca. 0
Irritation parameter:
iris score
Max. score:
0
Remarks on result:
other: Max. duration: 72 h; Max. value at end of observation period: CA 0 (related to all animals)
Irritant / corrosive response data:
The individual and mean scores obtained during the study are given in the full report (attached).
The ocular reactions observed during the study have been slight to moderate, and totally reversible in
the three animals:
- at the conjunctivae level: a slight to moderate redness, noted 24 hours after the test item instillation
and totally reversible between D6 and D7, associated with a slight chemosis, noted 1 hour after the test
item instillation and totally reversible between D1 and D7;
- at the corneal level: a slight opacity, registered only 24 hours after the test item instillation in one
animal.
Other effects:
Pas d'autres remarques, voir rapport.

Any other information on results incl. tables

Please refer to full report.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The results obtained, under these experimental conditions, enable to conclude that the test item
Noreenal :
- is slightly irritant for the eye (Max. O.I = 9.3) according to the classification established in the
Journal Officiel de la République Française dated July 10th, 1992.
- and, needs not to be classified according to the criteria for the classification, packaging and
labelling of dangerous substances and preparations.
Executive summary:

The test item Noreenal was instilled as supplied, into the eye of three New Zealand rabbits at

the dose of 0.1 mL. The experimental protocol was established on the basis of the official method as

defined in the O.E.C.D. guideline n° 405 dated April 24th, 2002 and the test method B.5 of the

directive 2004/73/EC.

The ocular reactions observed during the study have been slight to moderate, and totally reversible in

the three animals:

- at the conjunctivae level: a slight to moderate redness, noted 24 hours after the test item instillation

and totally reversible between D6 and D7, associated with a slight chemosis, noted 1 hour after the test

item instillation and totally reversible between D1 and D7;

- at the corneal level: a slight opacity, registered only 24 hours after the test item instillation in one

animal.

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

test item Noreenal 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. Directive n° 67/548,

2001/59 and 99/45. No symbol and risk phrase are required.