Registration Dossier
Registration Dossier
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EC number: 223-517-5 | CAS number: 3937-56-2
Endpoint summary
Administrative data
Description of key information
Skin irritation
1,9-Nonanediol was found to be devoid of primary skin irritation to the rabbit.
In a GLP, OECD 404 comparable study, 6 young adult New Zealand rabbits (3/sex), were exposed via the 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.
Eye irritation
In a standard guideline (OECD 405 comparable) and GLP compliant study in rabbits, 1,9-Nonanediol (45 mg) was instilled initially into the conjunctival sac of one eye of 3 young adult female New Zealand White rabbits. 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.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1981
- Deviations:
- no
- GLP compliance:
- yes
- 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% - 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 - 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.
- 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
- 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.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- 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
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1987
- Deviations:
- no
- GLP compliance:
- yes
- 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% - 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 - 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.
- 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
- 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.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Comparison with the CLP criteria
1,9 -Nonanediol was found to be of devoid of primary skin irritation in the rabbit. The animal model used involved application of the test article to pre-shaved abraded and non-abraded sites with an occlusive dressing applied for 24 h. Several deficiencies from the standard OECD 404 are noted; the data however represent a worst case, and are considered sufficient in addressing the endpoint. Therefore, 1,9 -Nonanediol does not meet the criteria for classification as a skin irritant.
In the unwashed eyes, there were no corneal or iridal changes in any animal. Conjunctival redness was observed in 3/3 animals at the 1 h time point. All effects had resolved by 24 h and therefore, 1,9 -Nonanediol does not meet the criteria for classification as an eye irritant.
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.
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.
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