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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 264-092-6 | CAS number: 63310-16-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15 November 1982 to 22 November 1982
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guidelines and the study was conducted under GLP conditions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 9-Octadecenoic acid (Z)-, monoester with 1,2,3-propanetriol ester with boric acid (H3BO3)
- EC Number:
- 264-092-6
- EC Name:
- 9-Octadecenoic acid (Z)-, monoester with 1,2,3-propanetriol ester with boric acid (H3BO3)
- Cas Number:
- 63310-16-7
- Molecular formula:
- C21H39O5B (based on the representative structure below)
- IUPAC Name:
- 2-hydroxy-3-{[hydroxy({2-hydroxy-3-[(9Z)-octadec-9-enoyloxy]propoxy})boranyl]oxy}propyl (9Z)-octadec-9-enoate; 3-{[bis({2-hydroxy-3-[(9Z)-octadec-9-enoyloxy]propoxy})boranyl]oxy}-2-hydroxypropyl (9Z)-octadec-9-enoate; {2-hydroxy-3-[(9Z)-octadec-9-enoyloxy]propoxy}boronic acid
- Test material form:
- liquid: viscous
- Details on test material:
- - Physical state: viscous brown liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Nitabell Rabbitry, Hayward, California, USA
- Age at study initiation: 9 - 11 weeks
- Weight at study initiation: 2.21 - 2.44 kg (males); 2.09 - 2.46 kg (females)
- Housing: individually in wire-bottom cages
- Diet: approximately 115 g Purina Rabbit Chow #5321, daily
- Water: ad libitum
- Acclimation period: 5 - 11 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): approximately 21 ºC
- Humidity (%): 55 - 77 %
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light
IN-LIFE DATES: From 15 November 1982 to 22 November 1982
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- - Dose administration: Approximately 0.1 mL test material was applied into the conjunctival sac of one eye of each rabbit. The other eye was untreated (control eye).
- Observation period (in vivo):
- Animals were observed up to 7 days post administration
- Number of animals or in vitro replicates:
- 9 animals
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Irrigation was performed on three of the rabbits by rinsing the control and treated eye for one minute at a rate of 250 mL per minute with distilled water 30 seconds after treatment.
SCORING SYSTEM:
The reactions observed were scored in accordance with the criteria of Draize (1959). See "Any other information on materials and methods incl. tables" for more information. All eyes were examined and graded for ocular reaction at one hour and at 1, 2, 3, 4 and 7 days.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 6.3
- Max. score:
- 20
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Unrinsed eyes
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 1.7
- Max. score:
- 20
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Unrinsed eyes
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 0.67
- Max. score:
- 20
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Unrinsed eyes
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 20
- Remarks on result:
- other: Unrinsed eyes
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 96 hours
- Score:
- 0
- Max. score:
- 20
- Remarks on result:
- other: Unrinsed eyes
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 7 days
- Score:
- 0
- Max. score:
- 20
- Remarks on result:
- other: Unrinsed eyes
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 4
- Max. score:
- 20
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Rinsed eyes
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 0.67
- Max. score:
- 20
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Rinsed eyes
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 0.67
- Max. score:
- 20
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Rinsed eyes
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 20
- Remarks on result:
- other: Rinsed eyes
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 96 hours
- Score:
- 0
- Max. score:
- 20
- Remarks on result:
- other: Rinsed eyes
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 7 days
- Score:
- 0
- Max. score:
- 20
- Remarks on result:
- other: Rinsed eyes
- Irritant / corrosive response data:
- Neither corneal opacity nor iritis was observed during the study. The test material caused very slight to severe conjunctival irritation in all treated-unrinsed eyes one hour after dosing. Moderate conjunctival irritation was observed in all treated-rinsed eyes one hour after dosing. Both treated-unrinsed and treated-rinsed eyes appeared normal by the 72 hour reading.
- Other effects:
- No signs of ill-health were noted in any animal during the study.
Any other information on results incl. tables
Table 2: Irritation Results of Treated Eyes
Time after treatment |
Rinsed/ Unrinsed |
Cornea |
Iris |
Conjunctivae |
Total individual scores |
Mean score |
|||
Opacity |
Area |
Redness |
Chemosis |
Discharge |
|||||
1 hour |
Unrinsed |
0 |
0 |
0 |
3 |
0 |
0 |
6 |
6.3 |
Unrinsed |
0 |
0 |
0 |
3 |
0 |
0 |
6 |
||
Unrinsed |
0 |
0 |
0 |
2 |
1 |
0 |
6 |
||
Unrinsed |
0 |
0 |
0 |
3 |
0 |
1 |
8 |
||
Unrinsed |
0 |
0 |
0 |
3 |
0 |
0 |
6 |
||
Unrinsed |
0 |
0 |
0 |
3 |
0 |
0 |
6 |
||
Rinsed |
0 |
0 |
0 |
2 |
0 |
0 |
4 |
4 |
|
Rinsed |
0 |
0 |
0 |
2 |
0 |
0 |
4 |
||
Rinsed |
0 |
0 |
0 |
2 |
0 |
0 |
4 |
||
24 hours |
Unrinsed |
0 |
0 |
0 |
1 |
0 |
0 |
2 |
1.7 |
Unrinsed |
0 |
0 |
0 |
2 |
0 |
0 |
4 |
||
Unrinsed |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Unrinsed |
0 |
0 |
0 |
1 |
0 |
0 |
2 |
||
Unrinsed |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Unrinsed |
0 |
0 |
0 |
1 |
0 |
0 |
2 |
||
Rinsed |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0.67 |
|
Rinsed |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Rinsed |
0 |
0 |
0 |
1 |
0 |
0 |
2 |
||
48 hours |
Unrinsed |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0.67 |
Unrinsed |
0 |
0 |
0 |
1 |
0 |
0 |
2 |
||
Unrinsed |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Unrinsed |
0 |
0 |
0 |
1 |
0 |
0 |
2 |
||
Unrinsed |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Unrinsed |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Rinsed |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0.67 |
|
Rinsed |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Rinsed |
0 |
0 |
0 |
1 |
0 |
0 |
2 |
||
72 hours |
Unrinsed |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Unrinsed |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Unrinsed |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Unrinsed |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Unrinsed |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Unrinsed |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Rinsed |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Rinsed |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Rinsed |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
96 hours |
Unrinsed |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Unrinsed |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Unrinsed |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Unrinsed |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Unrinsed |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Unrinsed |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Rinsed |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Rinsed |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Rinsed |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
7 days |
Unrinsed |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Unrinsed |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Unrinsed |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Unrinsed |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Unrinsed |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Unrinsed |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Rinsed |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Rinsed |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Rinsed |
0 |
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 conditions of the study, the test material only elicited slight reactions in any of the animals during the course of the study with all eyes appearing normal by 72 hours. The test material does not require classification as an eye irritant. The study is considered to be reliable, relevant and adequate for risk assessment and classification and labelling purposes.
- Executive summary:
The eye irritation potential of the test material was determined following a methodology equivalent to standardised guidelines OECD 405 and EU Method B.5. During the study 0.1 mL test material was applied into one eye of each of nine rabbits, the other eye remained untreated and served as a control. The treated and control eyes of three of the animals were rinsed with water 30 seconds after treatment. All animals were assessed for up to 7 days to determine the grade of ocular reaction. Under the conditions of the study neither corneal opacity nor iritis was observed. The test material caused very slight to severe conjunctival irritation in all treated-unrinsed eyes one hour after dosing. Moderate conjunctival irritation was observed in all treated-rinsed eyes one hour after dosing. Both treated-unrinsed and treated-rinsed eyes appeared normal by the 72 hour reading. In consideration of the ocular effects observed it was concluded that the test material does not require classification as an eye irritant.
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.
