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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 606-285-3 | CAS number: 1928-56-9
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: The study had been performed in accordance with OECD Guideline No.: 405.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- methyl (2,3-dichlorophenoxy)acetate
- EC Number:
- 606-285-3
- Cas Number:
- 1928-56-9
- Molecular formula:
- C9H8Cl2O3
- IUPAC Name:
- methyl (2,3-dichlorophenoxy)acetate
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material (as cited in study report): Dichlorophenoxyacetic acid methyl ester
- Physical state: almost white powder
- Purity test date: 26. 09. 2005
- Lot/batch No.: 3
- Expiration date of the lot/batch: : 07. 2006
- Storage condition of test material: at room temperature, protected 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: Breeder: Ferenc Sándor, Address: Császár street 135, H-2173 Kartal, Hungary
- Age at study initiation: 11 weeks, adult
- Weight at study initiation: 2892-3001 g
at study termination: 2944-3104 g
- Housing: individually in metal cages
- Diet (e.g. ad libitum): ad libitum, PURINA Base - Lap gr. diet for rabbits produced by AGRIBANDS Europe HungaryPLC.
- Water (e.g. ad libitum): ad libitum, tap water for human consumption from automatic self-supplying watering system
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the contralateral eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g of test item Dichlorophenoxyacetic acid methyl ester in pure state in a single dose - Duration of treatment / exposure:
- The eyes of the test animals were not washed out after the application of the test item.
- Observation period (in vivo):
- 72 hours (1, 24, 48 and 72 hours after the treatment)
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
The eyes of the test animals were not washed out after the application of the test item.
SCORING SYSTEM:
Draize (1959)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 1, 2, 3
- Time point:
- other: 1, 24, 48 and 72 hours after the application
- Score:
- 0 - 6
- Max. score:
- 20
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 1, 2, 3
- Time point:
- other: 1, 24, 48 and 72 hours after the application
- Score:
- 0
- Max. score:
- 80
- Irritation parameter:
- iris score
- Basis:
- animal: 1, 2, 3
- Time point:
- other: 1, 24, 48 and 72 hours after the application
- Score:
- 0
- Max. score:
- 10
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1, 24, 48 and 72 hours after the treatment
- Score:
- 4.66
- Max. score:
- 110
- Irritant / corrosive response data:
- One hour after treatment in all animals displayed some hyperaemic blood vessels (score 1). In two cases (No.: 5138, 5283) the discharge from the eye was greater than normal (score 1). In one case (No.: 5130) the discharge with moistening of the lids and hairs just adjacent to lids was found (score 2).
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item DICHLOROPHENOXYACETIC ACID METHYL ESTHER, applied to the rabbits' eye mucosa, caused irritant effects, which can be evaluated as fully reversible alterations within 24 hours. According to the EC criteria for classification and labelling requirements for dangerous substances and preparations the test item does not have to be classified and has no obligatory labelling requirement for eye irritaton.
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.
