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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 259-910-3 | CAS number: 55934-93-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- [(butoxymethylethoxy)methylethoxy]propan-1-ol
- EC Number:
- 259-910-3
- EC Name:
- [(butoxymethylethoxy)methylethoxy]propan-1-ol
- Cas Number:
- 55934-93-5
- Molecular formula:
- C13H28O4
- IUPAC Name:
- 1-[2-(2-butoxy-1-methylethoxy)-1-methylethoxy]propan-1-ol
- Details on test material:
- - Name of test material (as cited in study report): Solvenon TPNB
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Centre Lago S.A.,01540 Vonnas, France
- Age at study initiation: about 5 months
- Weight at study initiation: 3.02-3.36 kg
- Fasting period before study: none
- Housing: singel housing in stainless steel wire mesh cages with gating
- Diet: Kliba-Laboratory diet, Provima Kliba SA, Kaiseraugst, Swiss ad libitum
- Water: Tap water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12 hrs
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye
- Amount / concentration applied:
- undiluted
Amount applied: 0.1 ml - Duration of treatment / exposure:
- 24 hrs
- Observation period (in vivo):
- 72 hrs
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): tap water
- Time after start of exposure: 24 hours
SCORING SYSTEM:
Cornea opacity (op): Degree of density (the most dense area is taken for reading)
0 = No ulceration or opacity
1 = Scattered or diffuse areas of opacity (other than slight dulling of normal lustre) details of iris clearly visible
2 = Easily discernible translucent area, details of iris slightly obscured
3 = Nacreaous area, no details of iris visible, size of pupil barely discernible
4 = Opaque cornea, iris not discernible throught the opacity
Area of cornea involved (ar):
1 = > 0 <= 1/4
2 = > 1/4 < 1/2
3 = > 1/2 < 3/4
4 = > 3/4
Iris:
0 = Normal
1 = Merkedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia or injection, any of these observations or combination of any thereof, iris still reacting to light (sluggish reaction is positive)
2 = No reaction to light, haemorrhage, gross destruction (any or all of these)
Chemosis (sw):
Lids and/or nictating membranes
0 = no swelling
1 = Any swelling abnormal (includes nictitating membranes)
2 = Obvious swelling with partial eversion of lids
3 = Swelling of lids about half closed
4 = Swelling of lids more than half closed
Discharge (di):
0 = No discharge
1 = Any amount different from normal (does not include small amounts observed in inner canthus of normal animals)
2 = Discharge with moistening of the lids and hairs just adjacent to lids
3 = Discharge with moistening of the lids and hairs and considerable area around the eye
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- (animal 1-3)
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects observed
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- (animal 1-3)
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects observed
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- (animal 1-3)
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- other: all 3 animals showed redness (score 2) at the 1-h reading; redness was reversible within 48 h; see table below for details
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- (animal 1-3)
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: all 3 animals showed chemosis (2 animals: score 1; 1 animal: score 2) at the 1-h reading; chemosis was reversible within 24 h; see table below for details
Any other information on results incl. tables
Readings |
Animal |
Cornea |
Iris |
Conjunctiva |
Additional findings |
|||
op |
ar |
red |
ch |
di |
||||
1 h |
1 |
0 |
0 |
0 |
2 |
2 |
3 |
|
2 |
0 |
0 |
0 |
2 |
1 |
2 |
||
3 |
0 |
0 |
0 |
2 |
1 |
2 |
||
24 h |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
|
2 |
0 |
0 |
0 |
0 |
0 |
0 |
||
3 |
0 |
0 |
0 |
2 |
0 |
0 |
||
48 h |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2 |
0 |
0 |
0 |
0 |
0 |
0 |
||
3 |
0 |
0 |
0 |
0 |
0 |
0 |
||
72 h |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2 |
0 |
0 |
0 |
0 |
0 |
0 |
||
3 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Mean 24 -72 h |
1 |
0 |
0 |
0.3 |
0 |
|||
2 |
0 |
0 |
0.0 |
0 |
||||
3 |
0 |
0 |
0.7 |
0 |
||||
Mean |
0 |
0 |
0.3 |
0 |
||||
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information
- Conclusions:
- EU-Classification: not irritating
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.
