Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Diss Factsheets
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: 213-105-3 | CAS number: 924-44-7
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1990-12-15 to 1991-02-13
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study is well described and performed according to OECD testing guideline and GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Glyoxylate d'Ethyle
- IUPAC Name:
- Glyoxylate d'Ethyle
- Reference substance name:
- Ethyl glyoxylate
- EC Number:
- 213-105-3
- EC Name:
- Ethyl glyoxylate
- Cas Number:
- 924-44-7
- Molecular formula:
- C4 H6 O3
- IUPAC Name:
- ethyl glyoxylate
- Test material form:
- other: viscous liquid
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- - Source: Elevage Cunicole du Val de Selle, 80160 Prouzel, FRANCE.
- Weight at study initiation: average weight 2.7 ± 0.1 kg of the 3 males at the start of the experiment .
- Housing: Upon receipt, the animals received a preventive treatment for coccidiosis by administration of a Mucoxid (R) solution at the dose of 137.5 mg/kg/d at a volume of 10 ml/kg (Véda-Cogla, 45140 Saint Jean de la Ruelle, FRANCE). Observation was performed at the time of delivery of the animals and daily during the acclimatisation period. Animals were housed individually in cages of standard size. These cages were placed in an air-conditioned (20 ± 3°C) animal house kept at between 50 ± 20 % relative humidity. These parameters are recorded in each room. Non recycled air is filtered by absolute filters. The artificial day/night cycle was 12 hours light and 12 hours darkness.
- Diet (e.g. ad libitum): "Rabbits sustenance 112 C" from U.A.R. 91360 VILLEMOISSON SUR ORGE, was available ad libitum. A certificate of analysis (including the main contaminants) is provided by the supplier for every batch.
- Water (e.g. ad libitum): free access to tap water filtered by 0.22 micron filter membrane. Drinking water was available ad libitum in bottles. A specimen of water is regularly sent to a laboratory for bacteriological and chemical analysis (Laboratoire Municipal et Régional de Rouen, 76000 ROUEN, FRANCE.
- Acclimation period:For at least 5 days before the treatment, in the area where the experiment took place.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 ml
- Concentration: undiluted - Duration of treatment / exposure:
- one instillation (not rinsed)
- Observation period (in vivo):
- 72h
- Number of animals or in vitro replicates:
- 3 animals
- Details on study design:
- The test substance was first administred to 1 animal. As the substance was not irritant, the two additionnal animals were also tested.
The eyes were not rinced after administration of the substance.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0.1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0.78
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- At 1 hour and 24h : slight to moderate conjunctival reactions (chemosis: mean score 0.3 to 1.7 and enanthema : mean score 1 to 1.7). Lachrymation was marked in 1 animal after 24h.
At 48h : slight enanthema (score 1) in 2 animal with a slight discharge in 1 animal
at 72h : no reaction.
Any other information on results incl. tables
Mean value calculated from the scores recorded after 24, 48 and 72 hours for each animal
|
Animal |
Maximum score per site |
||
01 |
02 |
03 |
||
Chemosis |
0.3 |
0 |
0 |
1 after 24h |
Redness of the conjunctiva |
1.0 |
0.3 |
1.0 |
2 after 24 hours |
Iridic lesions |
0 |
0 |
0 |
|
Degree of corneal opacity |
0 |
0 |
0 |
|
Scores in the 3 animals at 1, 24, 48 and 72 hours
|
1 hour |
24 hours |
48 hours |
72 hours |
Chemosis |
2/1/2 |
1/0/0 |
0/0/0 |
0/0/0 |
Redness of the conjunctiva |
1/1/1 |
2/1/2 |
1/0/1 |
0/0/0 |
Iridic lesions |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
Degree of corneal opacity |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance Glyoxalate d'Ethyle (HF 7846) is not irritating to eye.
- Executive summary:
The substance Glyoxalate d'Ethyle (HF 7846) was tested for eye irritation / corrosion in rabbits according to OECD guideline n°405 and Good Laboratory Practices.
All scores are equal to 0, except for chemosis (mean score 0.3 to 1.7) and conjunctival redness (mean score 1 to 1.7). After 48h only a slight enanthema persist in 2 animals and at 72 hours no further ocular reactions were observed.
On the basis of these results, the Glyoxalate d'Ethyle (HF 7846) is not considered as irritating to the eye according the CLP Regulation No. 1272/2008.
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.