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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 425-400-6 | CAS number: 179986-09-5
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, GLP, QAU)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted February 24, 1987
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- -
- EC Number:
- 425-400-6
- EC Name:
- -
- Cas Number:
- 179986-09-5
- Molecular formula:
- UVCB substance
- IUPAC Name:
- methyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoate; propane-1,2,3-triol; tetradecanoic acid
- Details on test material:
- - Physical state: colourless liquid
- Analytical purity: 95%
- Storage condition of test material: at room temperature, away from light
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Dr. Karl Thomae GmbH
- Age at study initiation: 15 weeks
- Weight at study initiation: male: 3 kg, females: 2.8-3.1 kg
- Housing: Individually in stainless steel cages with an automatic cleaning system, equipped with feed hoppers.
- Diet (ad libitum): pelleted standard Kliba 341 rabbit maintenance diet
- Water (ad libitum): tap water
- Acclimation period: four days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The right eye remained untreated and served as the reference control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml - Duration of treatment / exposure:
- single treatment with 0.1 ml of the test substance
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3 (1 male, 2 females)
- Details on study design:
- SCORING SYSTEM: according to OECD guideline 405 Acute Eye Irritation/Corrosion
TOOL USED TO ASSESS SCORE: Varta Cliptrix diagnostic-lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24-48-72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24-48-72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24-48-72 hours
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24-48-72 hours
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Reddening and swelling of the conjunctivae, accompanied by watery discharge and hyperaemia of the scleral blood vessels were observed in all animals. Conjunctival reddening persisted in two animals for at least 48 hours and in one animal for at least 72 hours whereas hyperaemia, of the scleral blood vessels persisted for at least 48 hours. All findings were reversible after seven days. No staining of the cornea, sclera or conjunctivae of the treated eyes by the test article was observed.
Any other information on results incl. tables
Table 1: Eye irritation scores
Parameter |
Scoring time |
Test animals |
Mean of 3 animals |
||
#1 |
#2 |
#3 |
|||
Cornea opacity score |
1 hour |
0 |
0 |
0 |
0 |
24 hours |
0 |
0 |
0 |
0 |
|
48 hours |
0 |
0 |
0 |
0 |
|
72 hours |
0 |
0 |
0 |
0 |
|
7 days |
0 |
0 |
0 |
0 |
|
Mean 24-48-72 hour |
0 |
0 |
0 |
0 |
|
Iris score |
1 hour |
0 |
0 |
0 |
0 |
24 hours |
0 |
0 |
0 |
0 |
|
48 hours |
0 |
0 |
0 |
0 |
|
72 hours |
0 |
0 |
0 |
0 |
|
7 days |
0 |
0 |
0 |
0 |
|
Mean 24-48-72 hour |
0 |
0 |
0 |
0 |
|
Conjunctiva redness |
1 hour |
2 |
2 |
2 |
2 |
24 hours |
1 |
1 |
1 |
1 |
|
48 hours |
1 |
1 |
1 |
1 |
|
72 hours |
0 |
1 |
0 |
0.3 |
|
7 days |
0 |
0 |
0 |
0 |
|
Mean 24-48-72 hour |
0.6 |
1 |
0.6 |
0.7 |
|
Conjunctiva chemosis |
1 hour |
2 |
2 |
1 |
1.7 |
24 hours |
0 |
0 |
0 |
0 |
|
48 hours |
0 |
0 |
0 |
0 |
|
72 hours |
0 |
0 |
0 |
0 |
|
7 days |
0 |
0 |
0 |
0 |
|
Mean 24-48-72 hour |
0 |
0 |
0 |
0 |
|
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
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.
