Registration Dossier
Registration Dossier
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: 805-622-3 | CAS number: 10305-41-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17 Aug 2010 - 07 Sep 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted in 1981
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3-(cyclohexyloxy)propane-1,2-diol
- EC Number:
- 805-622-3
- Cas Number:
- 10305-41-6
- Molecular formula:
- C9H18O3
- IUPAC Name:
- 3-(cyclohexyloxy)propane-1,2-diol
- Reference substance name:
- 3-cyclohexyloxy-1,2-propanediol
- IUPAC Name:
- 3-cyclohexyloxy-1,2-propanediol
- Details on test material:
- - Name of test material (as cited in study report): SDX-3012
- Physical state: liquid
- Analytical purity: > 99%
- Lot/batch No.: 019X9
- Expiration date of the lot/batch: Oct.2010
- Storage condition of test material: room temperature (20.6-21.2 °C), nitrogen substitution
- Other: flash point: 159 °C
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: NZW (Yac:NZW(KBL)), SPF
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Cheonan Yonan College, Laboratory Animal Center, Korea.
- Age at study initiation: 16 weeks
- Weight at study initiation: 2.28-2.70 kg
- Housing: stainless wire mesh cages, 450W x 600D x 360H (mm). One animal per cage
- Diet: Purina experimental diet for rabbit 38302AF, ad libitum
- Water: public tap water in Cheongju-si was filtered and irradiated by ultraviolet light and provided ad libitum via an automatic watering system
- Acclimation period: at least 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.0 - 21.7
- Humidity (%): 47.1 - 69.6
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 2010-08-09 To: 2010-09-07
Test system
- Vehicle:
- water
- Controls:
- other: the untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): 10 and 50%
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): neat
- Lot/batch no.: GBA0001 - Duration of treatment / exposure:
- single application without washing
- Observation period (in vivo):
- 21 days
Reading time points: 1, 24, 48, 72 and 96h (10% test substance)
Reading time points: 1, 24, 48, 72 h and once daily thereafter for upto 21 days (50% test substance) - Number of animals or in vitro replicates:
- 3 males per concentration group
- Details on study design:
SCORING SYSTEM: Draize scoring system (1959)
TOOL USED TO ASSESS SCORE: hand-slit lamp (Kowa SL-15, Kowa Co., Ltd., Japan) and fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- other: mean out of 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 d in one out of 3 animals
- Remarks on result:
- other: 50% test substance
- Irritation parameter:
- iris score
- Basis:
- animal: mean out of 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: 50% test substance
- Irritation parameter:
- conjunctivae score
- Basis:
- other: mean out of 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 1.8
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 d in one out of 3 animals
- Remarks on result:
- other: 50% test substance
- Irritation parameter:
- chemosis score
- Basis:
- other: mean out of 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 d in two out of 3 animals
- Remarks on result:
- other: 50% test substance
- Irritation parameter:
- cornea opacity score
- Basis:
- other: mean out of 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Remarks on result:
- other: 10% test substance
- Irritation parameter:
- iris score
- Basis:
- other: mean out of 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Remarks on result:
- other: 10% test substance
- Irritation parameter:
- conjunctivae score
- Basis:
- other: mean out of 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.4
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: 10% test susbtance
- Irritation parameter:
- chemosis score
- Basis:
- animal: mean out of 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: 10% test substance
- Irritant / corrosive response data:
- 50% test substance group:
Redness of the conjunctiva (score 1) was evident in the eye of one animal on day 21. The corneal opacity (score 2), area of the opacity (score 2), redness of the conjunctiva (score 1) and chemosis in conjunctiva (score 1) were evident in the eye of one animal. No adverse effects on the conjunctiva, cornea and iris were evident in the eyes of one animal. Corneal vascularisation was evident from day 7 to day 21 in one animal as well as other eye irritations. In conclusion, irreversible effects to the conjunctiva and corneal were observed following instillation of the 50% test substance into the eyes of rabbits. See table 2 for more detail. - Other effects:
- No abnormal clinical signs or symptoms were evident in any animals throughout the duration of the study. All animals exhibited normal body weight gains. Mean body weight gains were 0.09 kg and 0.41 kg in the 10 and 50% test substance groups, respectively.
Any other information on results incl. tables
Table 1. Results of eye irritation from the 10% test substance.
Rabbit # |
Time |
conjunctivae |
iris |
cornea |
|
|
|
redness |
swelling |
|
|
1 |
1 h |
1 |
1 |
0 |
0 |
24 h |
1 |
1 |
0 |
0 |
|
48 h |
1 |
1 |
0 |
0 |
|
72 h |
0 |
0 |
0 |
0 |
|
96 h |
0 |
0 |
0 |
0 |
|
Mean |
24+48+72 h |
0.7 |
0.7 |
0.0 |
0.0 |
2 |
1 h |
1 |
1 |
0 |
0 |
24 h |
1 |
1 |
0 |
0 |
|
48 h |
0 |
0 |
0 |
0 |
|
72 h |
0 |
0 |
0 |
0 |
|
96 h |
0 |
0 |
0 |
0 |
|
Mean |
24+48+72 |
0.3 |
0.3 |
0.0 |
0.0 |
3 |
1 h |
1 |
1 |
0 |
0 |
24 h |
1 |
1 |
0 |
0 |
|
48 h |
0 |
0 |
0 |
0 |
|
72 h |
0 |
0 |
0 |
0 |
|
96 h |
0 |
0 |
0 |
0 |
|
Mean |
24+48+72 h |
0.3 |
0.3 |
0.0 |
0.0 |
Mean out of all 3 animals |
24+48+72 h |
0.4 |
0.4 |
0.0 |
0.0 |
Table 2. Results of eye irritation scores from the 50% test substance.
Rabbit # |
Time |
conjunctivae |
iris |
cornea |
|
|
|
redness |
swelling |
|
|
1 |
1 h |
1 |
3 |
0 |
0 |
24 h |
2 |
2 |
1 |
1 |
|
48 h |
2 |
2 |
0 |
1 |
|
72 h |
2 |
1 |
0 |
1 |
|
14 d |
1 |
1 |
0 |
0 |
|
21 d |
0 |
0 |
0 |
0 |
|
Mean |
24+48+72 h |
2.0 |
1.7 |
0.3 |
1.0 |
2 |
1 h |
1 |
3 |
0 |
0 |
24 h |
2 |
2 |
1 |
1 |
|
48 h |
2 |
2 |
0 |
1 |
|
72 h |
2 |
2 |
0 |
1 |
|
14 d |
1 |
1 |
0 |
2 |
|
21 d |
1 |
1 |
0 |
2 |
|
Mean |
24+48+72 h |
2.0 |
2 |
0.3 |
1.0 |
3 |
1 h |
1 |
3 |
0 |
0 |
24 h |
2 |
2 |
1 |
1 |
|
48 h |
2 |
2 |
0 |
1 |
|
72 h |
2 |
1 |
0 |
1 |
|
14 d |
1 |
1 |
0 |
0 |
|
21 d |
1 |
0 |
0 |
0 |
|
Mean |
24+48+72 h |
2.0 |
1.7 |
0.3 |
1.0 |
Mean out of all 3 animals |
24+48+72 h |
2 |
1.8 |
0.3 |
1 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye)
- Remarks:
- Migrated information at a concentration of 50% Criteria used for interpretation of results: EU
- Conclusions:
- CLP: Eye irrit 1, H318 for 50% test substance concentration; not classified for 10% test substance concentration
DSD: Xi; R41 for 50% test substance concentration; not classified for 10% test substance concentration
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.
