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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1988-10-04 to 1988-10-07
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:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1981
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

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Weight at dosing: 2.2 - 2.5 kg
Age: 10 - 11 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

Type of coverage:
occlusive
Preparation of test site:
abraded
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 g moistened with distiled water and applied to to an area 2.5 cm x 2.5 cm
Duration of treatment / exposure:
24 h / occulsive exposure to abraded and non-abraded skin
Observation period:
24 and 72 h post removal
Number of animals:
3/sex
Details on study design:
Six New Zealand White rabbits (3/sex) received a single 0.5 g of test article moistened with distilled water and applied to pre-shaved abraded and non abraded sites (each site covering 2.5 cm x 2.5 cm). A gauze pad covered the test site and was secured in place with an adhesive dressing (occlusive) and left for 24 h. The observation period was 72 h post removal.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Reversibility:
fully reversible
Irritant / corrosive response data:
Erythema (intact skin): No erythema was observed in any of the animals treated.
Oedema (intact skin): No oedema was observed in any of the animals treated.
Other effects:
Several deficiencies from the standard OECD 404 (exposure time 24 hours, rather than 4 hours, test article was applied under an occlusive dressing, rather than a semi-occlusive dressing). The data however represent a worst case, and are considered sufficient in addressing the endpoint

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 skin, according to the criteria of Draize. Therefore, according to Annex I Regulation (EC) 1272/2008 the active ingredient, 1,9 -Nonanediol has no obligatory labelling requirement for skin irritation and is unclassified.
Executive summary:

In a primary dermal irritation study, 6 young adult New Zealand rabbits (3/sex), were exposedviathe dermal by direct application. 0.5 g of test article moistened with distilled water and applied to pre-shaved abraded and non-abraded sites (each site covering 2.5 cm x 2.5 cm). A gauze pad covered the test site and was secured in place with an adhesive dressing (occlusive) and left for 24 h. The observation period was 72 h post removal. Irritation was scored using the Draize scheme.

 

No erythema or oedema were observed in any of the treated animals at 24 and 72 h after removal of the dressing. No dermal responses were apparent in any other animal.

 

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

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