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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 608-711-3 | CAS number: 32167-31-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study comparable to guideline study (partly limited documentation, e.g. no details about the test substance; 50 µL instead of 100 µL test substance instilled; eye not washed out).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 972
- Report date:
- 1972
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- (no details about the test substance; 50 µL instead of 100 µL test substance instilled.)
- Principles of method if other than guideline:
- Internal standardized test method (BASF-Test): 50 µL of the test substance were applied to the conjunctival sac of one eye in each of 2 animals. The animals were examined after 10 min, 1 and 3 h on the day of treatment and up to 8 days afterwards. Findings were recorded daily. The eyes were not washed out after 24 hours as specified in OECD Guideline 405.
- GLP compliance:
- no
Test material
- Reference substance name:
- Hydroxyethylated 2-butyne-1,4-diol
- EC Number:
- 608-711-3
- Cas Number:
- 32167-31-0
- Molecular formula:
- C4 H6 O2 (C2 H4 O) n, where 1 < n < 4.5
- IUPAC Name:
- Hydroxyethylated 2-butyne-1,4-diol
- Details on test material:
- - Name of test material (as cited in study report): Golpanol BEO = Golpanol SC 9189
- Physical state: liquid
- Analytical purity: no data
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: M. Gaukler, Offenbach, Germany
- Weight at study initiation: 2.66 kg (males); 3.12 kg (female)
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The adjacent eye served as control treated with NaCl.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µL
- Concentration: undiluted - Duration of treatment / exposure:
- single application (not washed out)
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 2 (1 male and 1 female)
- Details on study design:
- APPLICATION
Single application to the conjunctival sac of the right eyelid.
REMOVAL OF TEST SUBSTANCE
- The test substance was not washed out.
READINGS:
- 24, 48, 72 hours and 8 days after instillation.
SCORING SYSTEM: Draize scoring system, as recommended by the OECD guideline 405
TOOL USED TO ASSESS SCORE: fluorescein (at the end of exposure period)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- out of 2 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- out of 2 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- out of 2 animals
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- out of 2 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- The treatment led to conjunctivae redness with a score of 1 which persisted from 24 to 72 hours and was fully reversible within 8 days in 1/2 animals.
- Other effects:
- No other findings were observed.
Any other information on results incl. tables
Table 1. Results of eye irritation study.
Rabbit #
|
Time
|
conjunctivae |
iris
|
cornea
|
|
redness |
swelling |
||||
1
|
1 h |
1 |
0 |
0 |
0 |
24 h |
1 |
0 |
0 |
0 |
|
48 h |
1 |
0 |
0 |
0 |
|
72 h |
1 |
0 |
0 |
0 |
|
8 d |
0 |
0 |
0 |
0 |
|
average over 24, 48 and 72 h |
1.0 |
0.0 |
0.0 |
0.0 |
|
2
|
1 |
0 |
0 |
0 |
0 |
24 h |
0 |
0 |
0 |
0 |
|
48 h |
0 |
0 |
0 |
0 |
|
72 h |
0 |
0 |
0 |
0 |
|
8 d |
0 |
0 |
0 |
0 |
|
average over 24, 48 and 72 h |
0.0 |
0.0 |
0.0 |
0.0 |
|
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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.
