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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 600-975-8 | CAS number: 110615-47-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 29 Jan - 23 Feb 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- D-Glucopyranose, oligomeric, C10-16(even numbered) alkyl glycosides
- EC Number:
- 600-975-8
- Cas Number:
- 110615-47-9
- Molecular formula:
- Not applicable: UVCB
- IUPAC Name:
- D-Glucopyranose, oligomeric, C10-16(even numbered) alkyl glycosides
- Details on test material:
- - Name of test material (as cited in study report): trade name
- Physical state: yellow viscous liquid
- Analytical purity: 60% AS
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Kleinrusse, Chbb:HM
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Thomae, Biberach, Germany
- Weight at study initiation: 2372.5 g (mean)
- Housing: individually in rabbit batteries
- Diet: Altromin-Haltungsdiät 2023 (Altromin GmbH, Lage, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21
- Humidity (%): 45-55
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 g - Duration of treatment / exposure:
- single application without washing
- Observation period (in vivo):
- 21 days
Reading time points: 1, 6, 24, 48 and 72 h and 7, 10, 14, 17 and 21 days - Number of animals or in vitro replicates:
- 4
- Details on study design:
- SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 4 animals
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days in 1 animal
- Remarks on result:
- other: fully reversible within 7-21 days in 3 animals
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of 4 animals
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7-14 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- of 4 animals
- Time point:
- other: mean after 24/48/72 h
- Score:
- 2.1
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 days in 2 animals
- Remarks on result:
- other: fully reversible within 48 h to 10 days in 2 animals
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: mean after 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days in 1 animal
- Remarks on result:
- other: fully reversible within 48 h to 10 days in 3 animals
- Other effects:
- No further local or systemic effects were observed.
Any other information on results incl. tables
Table 1. Results of eye irritation study
Rabbit # |
Time [h] |
conjunctivae |
|
iris |
cornea |
redness |
chemosis |
||||
1 |
1 |
1 |
1 |
0 |
1 |
24 |
3 |
2 |
0 |
1 |
|
48 |
3 |
1 |
0 |
1 |
|
72 |
3 |
1 |
1 |
1 |
|
average |
3.00 |
1.33 |
0.33 |
1 |
|
2 |
1 |
1 |
2 |
0 |
1 |
24 |
2 |
1 |
0 |
0 |
|
48 |
1 |
1 |
0 |
0 |
|
72 |
1 |
0 |
0 |
0 |
|
average |
1.33 |
0.67 |
0 |
0 |
|
3 |
1 |
1 |
2 |
0 |
1 |
24 |
3 |
2 |
0 |
1 |
|
48 |
3 |
2 |
1 |
1 |
|
72 |
2 |
1 |
1 |
1 |
|
average |
2.67 |
1.67 |
0.67 |
1 |
|
4 |
1 |
1 |
2 |
0 |
1 |
24 |
2 |
1 |
0 |
0 |
|
48 |
1 |
1 |
0 |
0 |
|
72 |
1 |
1 |
0 |
0 |
|
average |
1.33 |
1.00 |
0 |
0 |
|
|
|
||||
Time [h] |
conjunctivae |
|
iris |
cornea |
|
|
redness |
swelling |
|
|
|
average |
1 |
1.00 |
1.75 |
0.00 |
1.00 |
24 |
2.50 |
1.50 |
0.00 |
0.50 |
|
48 |
2 |
1 |
0 |
1 |
|
72 |
2 |
1 |
1 |
1 |
|
24+48+72 |
2.08 |
1.17 |
0.25 |
0.50 |
|
Applicant's summary and conclusion
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: Eye Dam. 1, H318
DSD: Xi, R41
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.
