Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 205-585-8 | CAS number: 143-13-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted similarly to OECD Guideline 405 with deviations: non-GLP study; no data about purity and no certificate of analysis of test substance; no data on source, age, gender, weight and housing conditions of animals.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- no data about purity and no certificate of analysis of test substance; no data on source, age, gender, weight and housing conditions of animals
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- no
- Remarks:
- pre-GLP
Test material
- Reference substance name:
- Nonyl acetate
- EC Number:
- 205-585-8
- EC Name:
- Nonyl acetate
- Cas Number:
- 143-13-5
- Molecular formula:
- C11H22O2
- IUPAC Name:
- nonyl acetate
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): ACETATE DE NONYLE (n-nonyl acetate)
- Physical state: Liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- None
Test system
- Vehicle:
- other: neantine
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): 100, 30 and 10 % - Duration of treatment / exposure:
- No washing was done.
- Observation period (in vivo):
- 14 days
- Number of animals or in vitro replicates:
- 3 animals/group
- Details on study design:
- SCORING SYSTEM: Irritation reactions were observed at 1 h and 1, 2, 3, 7 and 14 days after treatment and graded according to Draize (1955) scoring system.
TOOL USED TO ASSESS SCORE: No data
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: for undiluted test item
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- other: for undiluted test item
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: for undiluted test item
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- other: for undiluted test item
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: for undiluted test item
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- other: for undiluted test item
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: for undiluted test item
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- other: for undiluted test item
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: for undiluted test item
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- other: for undiluted test item
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: for undiluted test item
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- other: for undiluted test item
- Irritant / corrosive response data:
- - Weak to moderate short lasting conjunctival irritation reactions were noted after instillation of undiluted test item.
- Moderate short lasting conjunctival irritation reactions were noted after instillation of 30 % test concentration.
- Minimal conjunctival irritation reactions were noted after instillation of 10 % test concentration.
- No alteration of the cornea could be observed macroscopically. - Other effects:
- No data
Any other information on results incl. tables
Table 7.3.2/1: Individual ocular examinations and mean values of the scores recorded for each animal (24, 48 and 72 h) after instillation of undiluted test item
Rabbit No. |
Region of eye |
Scores |
||||||
1 h |
24 h |
48 h |
72 h |
7 days |
14 days |
Mean (24, 48 and 72 h) |
||
1 |
Corneal opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae: Redness |
1 |
1 |
0 |
0 |
0 |
0 |
0.33 |
|
Conjunctivae: Chemosis |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2 |
Corneal opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae: Redness |
2 |
1 |
1 |
0 |
0 |
0 |
0.67 |
|
Conjunctivae: Chemosis |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3 |
Corneal opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae: Redness |
1 |
1 |
1 |
1 |
0 |
0 |
1 |
|
Conjunctivae: Chemosis |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, the test item ACETATE DE NONYLE (n-nonyl acetate) is not classified as irritating to eyes according to the Directive 67/548/EEC and the CLP Regulation (EC) N° (1272-2008).
- Executive summary:
In an eye irritation study conducted similarly to the OECD Guideline 405 (non-GLP study), 0.1 mL of the test item, ACETATE DE NONYLE (n-nonyl acetate), at concentrations of 100, 30 and 10 % in neantine was instilled into one eye of groups of rabbits (3/group). The other eye remained untreated and served as control. The eyes were examined and the changes were observed immediately after instillation and at 1 h and 1, 2, 3, 7 and 14 days after treatment and graded according to Draize (1955) scoring system.
Single application of the undiluted preparation caused weak to moderate short lasting conjunctival irritation. No alteration of the cornea could be observed macroscopically. Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were 0, 0, 0 for cornea score; 0, 0, 0 for iris score; 0.33, 0.67, 1.00 for conjunctivae score and 0, 0, 0 for chemosis score. Instillation of the diluted concentrations (10 and 30 %) of the test item caused minimal to moderate conjunctival irritation. In this study, test item ACETATE DE NONYLE (n-nonyl acetate) is non-irritating to eyes of rabbits.
Under the test conditions, the test item ACETATE DE NONYLE (n-nonyl acetate) is not classified as irritating to eyes according to the Directive 67/548/EEC and the CLP Regulation (EC) N° (1272-2008).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
