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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin 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 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.4 (Acute Toxicity: Dermal 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
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage Cunicole du Val de Selle, 80160 Prouzel, FRANCE.
- Weight at study initiation: average weight 2.5 ± 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: "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: 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
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 24 hours before the test, the flanks of each rabbit were partially clipped. Only animals showing no obvious signs of irritation were used for the experiment. 0.5 mL of the substance (as supplied) was added on an hydrophilic gauze patch (6 cm2) applied to the skin of the right flank region. The left flank did not receive any substance and served as a control.
The substance and the gauze patch were maintained in contact with the skin by a semi-occlusive and aerated hypoallergenic adhesive dressing attached with a gauze bandage. The 3 animals were fitted with this patch for 4 hours and then the dressing was removed and the animals placed back into their individual cages. No residual test substance was observed after its removal. - Duration of treatment / exposure:
- 4 hour
- Observation period:
- at 1h and then 24h, 48h and 72h after the patch removal. And then daily until reversibility of the reactions.
- Number of animals:
- 3
- Details on study design:
- The test item was applied once on the 3 animals for a duration of exposure of 4 hour under a semi-occlusive dressing. The cutaneous reactions were evaluated for Erythema and Oedema formation and their reversibility.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 1h
- Score:
- 2
- Max. score:
- 4
- Remarks on result:
- other: clearly visible erythema in 3 animals
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 2.7
- Max. score:
- 4
- Remarks on result:
- other: moderate to severe erythema in the 3 animals
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 3
- Max. score:
- 4
- Remarks on result:
- other: moderate to severe erythema in the 3 animals and greyish colouration in 2 animals
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 15 days
- Remarks on result:
- other: moderate to severe erythema in the 2 animals. A persistant crust persist at the end of the observation.
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 1h
- Score:
- 3.3
- Max. score:
- 4
- Remarks on result:
- other: slight in 1 animal and severe in 2 animal oedema
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.7
- Max. score:
- 4
- Remarks on result:
- other: very slight oedema in 2 animals
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- Observations on Erythema :
1 hour after the patch removal : clearly visible erythema in 3 animals.
At 24h and 48h : moderate to severe erythema in 3 animals and greyish colouration of the skin
At 72h : erythema disappeared in 1 animal and in the two others is moderate to severe.
The erythema became very slight between day 5 and 12 and the greyish colouration of the skin turned to a crust between day 13 and 15.
Observations on Oedema :
1 hour after the patch removal : slight oedema in 1 animal and severe in 2 animals
At 24 h : very slight oedeme in 2 animals
At 48h : no oedema observed
Any other information on results incl. tables
Mean value calculated from the scores recorded after 24h, 48h and 72h for each animal
|
ANIMAL |
Maximum score per site |
||
1 |
2 |
3 |
||
ERYTHEMA |
2.7 |
3.0 |
3.0 |
3 for 6 days |
OEDEMA |
0.0 |
0.3 |
0.3 |
1 after 24 hours |
Score for each animal at each time of observation
OBSERVATION Hour/Day |
ERYTHEMA |
OEDEMA |
||||
Animal 1 |
Animal 2 |
Animal 3 |
Animal 1 |
Animal 2 |
Animal 3 |
|
1h |
2 |
2 |
2 |
2 |
4 |
4 |
24h |
2 |
3 |
3 |
0 |
1 |
1 |
48h |
3 |
3/G |
3/G |
0 |
0 |
0 |
72h |
3 |
3/G |
3/G |
0 |
0 |
0 |
5d |
2 |
3/G |
2/G |
0 |
0 |
0 |
6d |
2 |
3/G |
2/G |
0 |
0 |
0 |
7d |
1/D |
3/D/G |
2/D/G |
0 |
0 |
0 |
8d |
0/D |
2/D/G |
1/D/G |
0 |
0 |
0 |
9d |
0/D |
2/D/G |
1/D/G |
0 |
0 |
0 |
10d |
0/D |
1/D/G |
1/D/G |
0 |
0 |
0 |
11d |
0 |
1/D/G |
1/D/G |
0 |
0 |
0 |
12d |
- |
1/D/G |
1/D/G |
- |
0 |
0 |
13d |
- |
0/A |
0/A |
- |
0 |
0 |
14d |
- |
0/A |
0/A |
- |
0 |
0 |
G = Grey coloration of the skin
G = Grey coloration of the skin
D = Desquamation
A = crust
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to the results of this test, the substance is considered as irritant to the skin in rabbits.
- Executive summary:
Any irritant property and/or degree of corrosion of the substance Glyoxalate d'Ethyle (HF 7846) was evaluated in the rabbits following a single semi-occluded application to intact skin in accordance with the method B4 of Commission Directive 84/449/CEE and following the GLP.
3 animals were used for this study.
0.5 mL of HF 7846 was applied on the skin via an absorbent gauze. Adjacent surfaces of untreated skin served as a control for the trial. Semi-occlusive dressings held the test item in place for 4 hours on the skin of 3 animals. After patch removal, the cutaneous reactions were evaluated at different times (1h, 24, 48h and 72h) for Erythema and Oedema formation and their reversibility (until day 15).
At 24h and 48h severe to moderate erythema was observed in at least 2 animals and a greyish coloration was also noted for 2 animals.
The reactions were completely reversible in one week in one animal or remained moderate for 14 days in 2 animals. The greyish coloration was replaced by a persistent crust between day 13 and the end of the observation.
A slight oedema was observed in 1 animal and a severe oedema in 2 animals after 1 hour of patch removal. But this oedema disapears at 48h in all animals.
According to the results of this test, the substance is classified as irritant catg. 2, according to the CLP Regulation No. 1272/2008.
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