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EC number: 206-330-3 | CAS number: 328-50-7
- 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
Endpoint summary
Administrative data
Description of key information
Skin irritation/corrosion: non-GLP, OECD TG 401 (adopted 1981) compliant study, rabbits, 2 -oxoglutaric acid, not classified, effects fully reversible
Eye irritation/corrosion: non-GLP, OECD TG 405 (adopted 1981) compliant study, rabbits, 2 -oxoglutaric acid, severely irritant Cat.1
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1984-01-24 to1984-02-21
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted 1981
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: white russian
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 4-6 months
- Weight at study initiation: 1.8-2.5 kg
- Housing: singly in stainless steel cages model: Asta
- Diet (e.g. ad libitum): ad libitum, standard chow: ALTROMIN
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 day
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 1°C
- Humidity (%): 50-60 %
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light - Type of coverage:
- occlusive
- Preparation of test site:
- other: intact and abraded skin
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: left side intact, untreated areas
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg test item moistened with water - Duration of treatment / exposure:
- 4 hour exposure
- Observation period:
- up to 14 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6.25 cm²/animal
- Type of wrap if used: Areas were covered by linen patches which were fixed with Acylastic, P.Beiersdorf und Co. AG, Hamburg
- Differences to guideline: Abraded and intact skin was treated and observed, but only intact skin was used for evaluation.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing
SCORING SYSTEM:
- Method of calculation: Scoring according to the method of Draize et al., 1944 - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- other: effects on intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- other: effects on intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- other: effects on intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: effects on intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal: #2,#3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: effects on intact skin
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the present conditions, occlusive application of the test item for 4 hours to intact and abraded rabbit skin revealed moderate irritating effects (moderate erythrema and slight edema) only in one out of three animals. The other two animals showed no reaction or exhibited a slightly irritating effect, respectively. However, these effects were fully reversible after maximum 6 days. Therefore the test item is not classified according to GHS citeria.
Reference
Table 1: Irritant/corrosive response data for each animal on intact skin at each observation time up to removal of each animal from the test
Score at time point/ Reversibility |
Erythema |
Edema |
|
Max. score: 4 |
Max. score: 2 |
24 h |
3/0/0 |
1/0/0 |
48 h |
2/1/1 |
1/0/0 |
72 h |
1/1/1 |
0/0/0 |
Average 24 h, 48 h, 72 h |
2/0.67/0.67 |
0.67/0/0 |
Reversibility *) |
c. |
c. |
Average time (unit) for reversion |
6 days |
6 days |
*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- 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:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted 1981
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- other: white russian
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 6 month
- Weight at study initiation: 2.1-2.2 kg
- Housing: singly in stainless steel cages model: ASTA
- Diet (e.g. ad libitum): sniff (K) Alleindiät für Kaninchen, ad libitum
- Water (e.g. ad libitum): Trinkwasserqualität der Stadtwerke Bielefeld, ad libitum
- Acclimation period: 1 day
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 2°C
- Humidity (%): 55% ± 15%
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g of the test substance was instilled in the conjunctival sac of the right eye. - Duration of treatment / exposure:
- 100 mg of the test article (undiluted) was placed in the conjunctival sac of the right eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of the test article. The eyes were not rinsed.
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 3 female rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): There was no washing of the eyes.
- Scoring system: OECD TG 405 / Draize scale - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3.67
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: observed petechiae
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3.67
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Max. score:
- 2
- Remarks on result:
- other: could not be evaluated due to corneal opacity
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Max. score:
- 2
- Remarks on result:
- other: could not be evaluated due to corneal opacity
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: ulcerous and necrotic areas
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: ulcerous and necrotic areas
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3.67
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: completely closed eyes
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3.67
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: completely closed eyes
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Other effects:
- - Other observations: Severe reactions after instillation of the substance, adverse effects on the iris could not be detected due to the non-reversible, strong opacity of the cornea.
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- The test substance was tested for eye irritation in a study according to OECD guideline 405 (Acute Eye Irritation / Corrosion). The substance was instilled into the conjunctival sac of three white russian rabbits. The opacity of the cornea was severe among the animals and the effect was not reversible within 21 days in two of the rabbits. Chemosis and conjunctival effects were also severe and not reversible within 21 days. In this study the test item has irreversible severe effects on the eye and is therefore classified in Category 1.
Reference
Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test
Score at time point / Reversibility |
Cornea |
Iris |
Conjuctivae |
Chemosis |
|
Max. score: 4 |
Max. score: 3 |
Max. score: 3 |
Max. score: 4 |
60 min |
4/3/3 |
1/1/1 |
0/0/0 |
2/2/2 |
24 h |
3/3/3 |
**) n.d./n.d./1 |
3/3/2 |
3/3/3 |
48 h |
4/4/3 |
n.d./n.d./1 |
3/3/2 |
4/4/3 |
72 h |
4/4/3 |
n.d./n.d./1 |
3/3/2 |
4/4/3 |
Average 24 h, 48 h, 72 h |
3.67/3.67/3 |
n.d./n.d./1 |
3/3/2 |
3.67/3.67/3 |
Reversibility |
n. |
n. |
n. |
n. |
Average time (unit) for reversion |
n. |
n. |
n. |
n. |
*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
**) n.d. = not detectable
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Based on the available data 2 -oxoglutaric acid is classified as non-irritating to the skin but is categorized to cause serious damage to the eyes (Category 1) and labelled with H318 (Causes serious eye damage) according to Regulation (EC) 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labeling of Chemicals (GHS).
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