Registration Dossier

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1988-10-10 to 1988-10-24
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1987
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Nonane-1,9-diol
EC Number:
223-517-5
EC Name:
Nonane-1,9-diol
Cas Number:
3937-56-2
Molecular formula:
C9H20O2
IUPAC Name:
nonane-1,9-diol
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Chemical name: 1,9-Nonanediol
- CAS no.: 3937-56-2
- Molecular weight: 160.254 g/mol
- Purity: 99.9%

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Weight at dosing: 2.8 - 3.5 kg
Age: 12 wks
Source: Froxfield Rabbits, Petersfield, Hampshire, England
Acclimation period: not stated
Diet: SDS Standard Rabbit Diet, ad libitum
Water: Municipal water, ad libitum
Housing: Singly housed
Temperature: 19°C
Humidity: 30-70%
Air changes: 19 changes/h
Photoperiod: 12 hours light/dark

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
45 mg
Duration of treatment / exposure:
single exposure
Observation period (in vivo):
1 h, 1, 2, 3, 4 and 7 days
Number of animals or in vitro replicates:
3 days
Details on study design:
Three New Zealand White (2M, 1F) rabbits received a single ocular dose of 45 mg of test article (equivalent to a volume of 0.1 mL) instilled into the lower lid of one eye. Eye lids were held to together for ~1 second to prevent loss of material. The other eye served as a control. The eyes remained unwashed. The observation period was 7 days.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the results of this study, 1,9-Nonanediol was deemed to be non-irritant or non-corrosive to the eye, according to the criteria of Draize. Therefore, according to Annex I for Regulation (EC) 1272/2008 the active ingredient, 1,9-Nonanediol has no obligatory labelling requirement for eye irritation and is unclassified.
Executive summary:

In a primary eye irritation study, 3 young adult New Zealand rabbits received a single ocular dose of 45 mg of test article instilled into the lower lid of one eye. Eye lids were held to together for ~1 second to prevent loss of material. The other eye served as a control. The eyes remained unwashed. The observation period was 7 days. Irritation was scored using the Draize scheme.

 

1,9-Nonanediol caused slight conjunctival redness in all 3 animals at the 1 hour time point only. No corneal or iridial irritation was observed. Reactions had completely resolved by day 1 in all animals.

 

Based on the results of this study, 1,9-Nonanediol was deemed to be non-irritant or non-corrosive to the eye, according to the criteria of Draize. Therefore, according to Annex I for Regulation (EC) 1272/2008 the active ingredient, 1,9-Nonanediol has no obligatory labelling requirement for eye irritation and is unclassified.