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EC number: 224-923-5 | CAS number: 4553-62-2
- 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
- Study period:
- Not stated
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions. The purity is not indicated.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Not stated
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guidelile study with acceptable restrictions. The purity is not indicated.
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- : 4 animals, eye irritation graded according to the Draize scale.
- Principles of method if other than guideline:
- This test has been performed according to the experimental protocol similar to the Draize test.
Draize (J.H.), in "Appraisal of the safety of chemicals in foods, drugs and cosmetics", Assocaition of Food and Drug Officials of the United States
published by the Editorial Committe, Baltimore (1959) - GLP compliance:
- no
- Remarks:
- Study performed before GLP statement
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: No data
- Age at study initiation: No data
- Weight at study initiation: 2,0 to 3.0 kg
- Housing: No data
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: No data
ENVIRONMENTAL CONDITIONS:
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr):no data
- Photoperiod (hrs dark / hrs light): no data
IN-LIFE DATES: no data - Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): no data
- Duration of treatment / exposure:
- Eyes were not rinsed
- Observation period (in vivo):
- Eyes are observed 1, 24, 48, 72, 96 h and 7 days after application
- Number of animals or in vitro replicates:
- 4
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): No washing
SCORING SYSTEM: according to Draize scale.
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein: No data - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of all animals (n=4)
- Time point:
- 24/48/72 h
- Score:
- 0.25
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of all animals (n=4)
- Time point:
- 24/48/72 h
- Score:
- 0.25
- Max. score:
- 2
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- of all animals (n=4)
- Time point:
- 24/48/72 h
- Score:
- 0.25
- Max. score:
- 3
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of all animals (n=4)
- Time point:
- 24/48/72 h
- Score:
- 0.42
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Irritant / corrosive response data:
- The acute Ocular Irritation Index is 19.75 and after 4 days about 0.00. See details in Table 7.3.2/1
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, 2-methylglutaronitrile is slighlty irritating to the eyes but is not classified according to the criteria of CLP regulation (EC) N°(1272-2008) and to the Annex VI of the Directive 67/548/EEC.
- Executive summary:
In an eye irritation study performed similarly to the OECD guideline No. 405 with some acceptable deviations (Draize experimental protocol), 0.1 mL of undiluted 2-Methylglutaronitrile was instilled into the conjunctival sac of left eye of 4 New Zealand White rabbits. The eyes of the animals were not rinsed after instillation and were examined and the changes graded according to the Draize scale at 1, 24, 48, 72, 96 hrs and 7 days after application.
The mean values for the 4 animals and for the timepoints 24, 48 and 72 hrs were respectively for cornea, iris, conjunctivae and chemosis of 0.25, 0.25, 0.25 and 0.42. All of these effects were totally reversed after 3 days.
Under these test conditions, 2-methylglutaronitrile is considered as slightly irritating to eyes but no classification is required according to the criteria of the CLP regulation (EC) N°(1271 -2008) and to the Annex VI to the Directive 67/548/EEC.
Table 7.3.2/1: 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 |
Conjunctivae |
Chemosis |
Max. score: 4 |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
|
60 min |
1/1/1/2 |
1/1/1/1 |
2/2/1/2 |
2/1/1/2 |
24 h |
1/1/0/1 |
1/1/0/1 |
1/1/0/1 |
1/1/1/1 |
48 h |
0/0/0/0 |
0/0/0/0 |
0/0/0/0 |
0/0/0/1 |
72 h |
0/0/0/0 |
0/0/0/0 |
0/0/0/0 |
0/0/0/0 |
Average 24h, 48h, 72h |
0.25 |
0.25 |
0.25 |
0.42 |
Reversibility*) |
c/c/c/c |
c/c/c/c |
c/c/c/c |
c/c/c/c |
Average time (day) for reversion |
2/2/1/2 |
2/2/1/2 |
2/2/1/2 |
2/2/2/3 |
*) Reversibility: c. = completely reversible
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- 4 animals, occlusive dressing, exposure period of 24 hrs, observation time point at 1hr and 48 hrs after dressing removal (24hrs and 72 hrs time point are missing)
- Principles of method if other than guideline:
- Experimental protocol of DRAIZE or " patch-test technique"
Draize (J.H.) in "Appraisal of the safety of chemicals in foods, drugs and cosmetics", association of Food and Drug Officials of the United States
published by the Editorial Committes, Baltimore (1959), p'46. - GLP compliance:
- no
- Remarks:
- Study performed before GLP statement
Test material
- Reference substance name:
- 2-methylglutaronitrile
- EC Number:
- 224-923-5
- EC Name:
- 2-methylglutaronitrile
- Cas Number:
- 4553-62-2
- Molecular formula:
- C6H8N2
- IUPAC Name:
- 2-methylpentanedinitrile
- Details on test material:
- - Name of test material (as cited in study report): methylglutaronitrile
- Physical state: colorless liquid
No other data available
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 2.5 to 3.5 kg
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS: No data
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): no data
VEHICLE: none - Duration of treatment / exposure:
- Duration of the exposure treatment: 24h
- Observation period:
- Animals are observed 1 and 48 hour after patch removal.
- Number of animals:
- 4
- Details on study design:
- TEST SITE
- Area of exposure: disk of 3 cm of diameter
- % coverage: no data
- Type of wrap if used: adhesive tape and a bandage enveloping all the trunk of the animal
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No washing
- Time after start of exposure: 1 and 48h
SCORING SYSTEM: Draize scale
After clipping the skin, 0.5 ml of the test substance has been applied to a small disk of 3 cm of diameter which is directly applied to the skin.
Contact with the skin is held with adhesive tape and a bandage around the trunk of the animal.
Before exposure the skin of animals is either left intact or scarified.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- intact skin
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Overall 25 and 72 hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- intact skin
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Overall 25 and 72 hours
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Remarks:
- intact and abraded skin
- Time point:
- other: Overall 25 and 72 hours
- Score:
- 0.25
- Max. score:
- 12
- Reversibility:
- fully reversible within: 72 hrs
- Remarks on result:
- other: this index is equal to the sum of the scores for erythema and edema at 25 and 72 hrs after the application for the both intact and abraded skin, divided by 16 (number of treated rabbits multiplied by 4).
- Irritant / corrosive response data:
- Refering to the table 7.3.1; The Primary Dermal Irritation Index is 0.25. One time point of observation, 24h, is missing.
- Other effects:
- No other effects reported.
Any other information on results incl. tables
Table 7.3.1/1:Mean irritant/corrosive response data for each animal with intact skin at each observation time up to removal of animals from the test
Score at time point / Reversibility |
Erythema Max. score 4 |
Edema Max. score 4 |
25 h after the start of test item application |
0/0/0/0 |
0/0/0/0 |
72 h after the start of test item application |
0/0/0/0 |
0/0/0/0 |
Average 25h, 72h (mean of all animals) |
0.0 |
0.0 |
Reversibility*) |
c/c/c/c |
c/c/c/c |
Average time (hrs) for reversion |
- |
- |
Table 7.3.1/2: Mean irritant/corrosive response data for animals with abraded skin at each observation time up to removal of animals from the test
Score at time point / Reversibility |
Erythema Max. score 4 |
Edema Max. score 4 |
25 h after the start of test item application |
1/1/1/0 |
0/1/0/0 |
72 h after the start of test item application |
0/0/0/0 |
0/0/0/0 |
Average 25h, 72h |
0.375 |
0.125 |
Reversibility*) |
c/c/c/- |
-/c/-/- |
Average time (hrs) for reversion |
72/72/72/- |
-/72/-/- |
*) Reversibility: c. = completely reversible
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, 2-methylglutaronitrile is considered as not irritating to the skin according to the criteria of CLP Regulation (EC) N° (1272-2008) and to the Annex VI to the Directive 67/548/EEC.
- Executive summary:
In a skin irritation study, performed according to the Draize experiment protocol, 4 albinos rabbits (New Zealand) were exposed, for 24 hours to 2-methylglutaronitrile. The observation timepoint were 1h and 48h after patch removal. Timepoint 24h and 72 hours after removal of the patch were not been evaluated.
The mean scores (25 and 72 hours after the strat of test item application) were 0.00 for erythema and oedema (intact skin).
The mean scores (25 and 72 hours after the start of test item application) were 0.4 for erythema and 0.1 for oedema (abraded skin). These effects were reversible after 72 hours of exposure.
Under the test conditions, based on the mean scores for erythema end oedema = 0.00 (intact skin), 2 -methylglutaronitrile is considered as not irritating to the skin according to the criteria of CLP Regulation (EC) N° (1272-2008) and to the Annex VI to the Directive 67/548/EEC.
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