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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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- 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: The study is similar to the 402 OECD. The GLP are not stated. The purity is not indicated.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- No data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study is comparable to OECD 401. It is well conducted but not GLP. The purity is not indicated.
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- : Minor deviation: Age at study initiation is not mentionned.
- GLP compliance:
- no
- Remarks:
- study performed before GLP statement
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: IFFA CREDO
- Age at study initiation: no data
- Weight at study initiation: 160-180g
- Fasting period before study: yes, approximately 17/19h before test substance administration
- Housing: cage dimension 37.5 x 23.5 x 16 cm, 5 animals per cage
- Diet: IFFARAT, ad libitum
- Water: ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature: 22°C +/- 1°C
- Humidity: 50% +/- 10%
- Air changes: 8 per hr
- Photoperiod (hrs dark / hrs light): no data
IN-LIFE DATES: No data - Route of administration:
- oral: gavage
- Vehicle:
- other: aqueous suspension of 10% arabic gum
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: no data
- Justification for choice of vehicle: No data
- Lot/batch no. (if required): No data
- Purity: No data
MAXIMUM DOSE VOLUME APPLIED: 8 mL/kg
- Rationale for the selection of the starting dose: A preliminary study was conducted. 5 groups (2M + 2F each) were exposed to 100, 500, 1000, 2500 or 5000 mg/kg of MGN, and observed for 14 days. - Doses:
- 150, 200, 250, 300 and 400 mg/kg bw
- No. of animals per sex per dose:
- 5 animals/sex/dose
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
* Behaviour and mortality: immediatly after exposure, then 1, 2 and 6 h after exposure and then daily until day 14.
* Body weight: at 0, 1, 2, 4, 7 and 14 days after exposure
- Necropsy of survivors performed: yes - Statistics:
- The LD50 was calculated by the method of Litchfield and Wilcoxon
- Preliminary study:
- 100 % mortality was observed at 500 mg/kg bw and above.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 205 mg/kg bw
- 95% CL:
- >= 174 - <= 243
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 170 mg/kg bw
- Remarks on result:
- other: Not presented in the report but it is calculated
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 225 mg/kg bw
- Remarks on result:
- other: Not presented in the report but it is calculated
- Mortality:
- Males are more sensitive than females. See detailed results in table 7.2.1/2.
In Males:
- 20% mortality was observed at 150 mg/kg bw
- 80% mortality was observed at 200, 250 and 300 mg/kg bw
- 100 % mortality was observed at 400 mg/kg bw
In females:
- 0% mortality was observed at 150 mg/kg bw
- 20% mortality was observed at 200 mg/kg bw
- 40% mortality was observed at 250 mg/kg bw
- 100 % mortality was observed at 300 and 400 mg/kg bw - Clinical signs:
- other: - At all doses tested (males and females): reduced activity, apathy, prostration, piloerection, trembling and convulsion were observed. These effects were reversible 24 hours after treatment.
- Gross pathology:
- - The autopsy of animals died during the test revealed haemorrhagic digestive tract, thymus and lungs.
- No macroscopic abnormalities were observed in the surviving animals. - Other findings:
- No remarks
- Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- Under the test conditions of this study, males were more sensitive than female rats. Therefore, based on the oral LD50 of male rats considering as the worst case, 2-Methylglutaronitrile is considered in Category 3 (H301: Toxic if swallowed ) according to the Regulation 1272/2008 and as toxic if swallowed (T, R25) according to the Directive 67/548/EEC.
- Executive summary:
In an acute oral toxicity study performed similarly to the OECD test guideline No. 401, groups of fasted Sprague-Dawley rat (5/sex/group) were given a single oral dose of 2- Methylglutaronitrile (2-MGN) in aqueous suspension of 10% arabic gum at doses of 0, 150, 200, 250, 300 or 400 mg/kg bw and observed for 14 days. At all doses tested (males and females), the clinical signs observed were reduced activity, apathy, prostration, piloerection, trembling and convulsion. All these signs were reversible 24 hours after the treatment. Haemorrhagic digestive tract, thymus and lungs was observed in the animals died during the study. The body weight and weight gain were not affected.
Oral LD50male/female = 205 mg/kg bw
Oral LD50male = 170 mg/kg bw
Oral LD50 female = 225 mg/kg bw
Based on the oral LD50 of male rats considering as the worst case (more sensitive than female), 2-Methylglutaronitrile is considered in Category 3 (H301: toxic if swallowed) according to the Regulation 1272/2008/EC and as toxic if swallowed (T, R25) according to the Directive 67/548/EEC.
Table 7.2.1/2: Number of animals dead
Dose |
Mortality (# dead/total) |
Time range of deaths |
||
Male |
Female |
Combined |
|
|
0 |
0/5 |
0/5 |
0/10 |
- |
150 |
2/5 |
0/5 |
2/10 |
day 1 |
200 |
4/5 |
1/5 |
5/10 |
2h (2 males), 6h (2 males), 6h (1 female) |
250 |
4/5 |
2/5 |
6/10 |
6 h (1 male), 1 d (3 males), 1 d (2 female)
|
300 |
4/5 |
5/5 |
9/10 |
2 h (1 male), 6 h (3males), 6 h(2 females), d1 (3 females) |
400 |
5/5 |
5/5 |
10/10 |
2h (3 males), 6h (2 males), 6 h (5 females) |
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 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- : Occlusive conditions
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- no
- Remarks:
- Study performed before GLP statement.
- Test type:
- standard acute method
- Limit test:
- no
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
- Reference substance name:
- methyl-2-glutaronitrile
- IUPAC Name:
- methyl-2-glutaronitrile
- Details on test material:
- - Name of test material (as cited in study report): Methylglutaronitrile technique
- Physical state: clear liquid
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: IFFA CREDO
- Age at study initiation: No data
- Weight at study initiation: 160-180g
- Fasting period before study: no data
- Housing: cage dimension 37.5 x 17 x 15 cm, 1 animal per cage
- Diet: IFFARAT, ad libitum
- Water: ad libitum
- Acclimation period: No data
ENVIRONMENTAL CONDITIONS
- Temperature: 22°C +/- 1°C
- Humidity: 50% +/- 10%
- Air changes: 8 per hr
- Photoperiod: No data
IN-LIFE DATES: No data
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: on the back
- % coverage: no data
- Type of wrap if used: aluminium and sparadrap
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No
TEST MATERIAL
- Amount(s) applied: 1.05, 1.16, 1.58 and 2.11 ml/kg
- Constant volume or concentration used: no - Duration of exposure:
- 24 hours
- Doses:
- 1000, 1100, 1500 and 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 animals/sex/dose for 1500 and 2000 mg/kg bw
10 animals/sex/dose for 1000 and 1100 mg/kg bw - Control animals:
- yes, concurrent no treatment
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Behaviour and mortality: immediately after exposure, then 1, 2 and 6h after exposure and then daily until day 14
Body weight: at 0, 1, 2, 4, 7 and 14 after exposure
- Necropsy of survivors performed: yes - Statistics:
- The LD50 was calculated by the method of Litchfield and Wilcoxon
Results and discussion
- Preliminary study:
- A preliminary study was conducted. Three groups (2M + 2F each) were exposed in the same conditions (except the use of an aqueous dispersion of 10% arabic gum as vehicle for 100 and 500 mg/kg bw) to 100, 500 and 1000 mg/kg of methylglutaronitrile, and observed for 14 days. At 100 mg/kg, no mortality was observed. At 500 mg/kg, 2/2 males and 0/2 females died. At 1000 mg/kg, 1/2 males and 0/2 females died.
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 1 154 mg/kg bw
- 95% CL:
- >= 1 004 - <= 1 328
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 982 mg/kg bw
- Remarks on result:
- other: Not presented in the report but determined by our own calculation
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 1 403 mg/kg bw
- Remarks on result:
- other: Not presented in the report but determined by our own calculation
- Mortality:
- At equivalent dose level, mortality was more pronounced in males than in females. See detailed results in table 7.2.3/2
- Clinical signs:
- other: Reduced activity, apathy, prostration, slight ptosis, slight tremor.
- Gross pathology:
- The autopsy of animals died during the test revealed:
- haemorrhagic lungs,
- pale and mottled liver,
- thickened peritoneum,
- hemorrhagic patch on the skin.
No macroscopic abnormalities were observed in the surviving animals. - Other findings:
- No other fingings. No skin lesions.
Any other information on results incl. tables
Table 7.2.3/2: Number of animals dead
Dose |
Volume (mL/kg) |
Mortality (# dead/total) |
Time range of deaths |
||
Male |
Female |
Combined |
|
||
0 |
- |
0/5 |
0/5 |
0/10 |
- |
1000 |
1.05 |
4/10 |
1/10 |
5/20 |
day1 (2M); days 3 +4 (3M), days 7 +14 (4M) day 1 -14 (1F) |
1100 |
1.16 |
7/10 |
4/10 |
11/20 |
day 1(6 M), days 2 -14 (7M) day1 (1F), day 14(4F) |
1500 |
1.58 |
5/5 |
3/5 |
8/10 |
day1 (4M), day2 (5M) day 1-14 (3F) |
2000 |
2.11 |
5/5 |
4/5 |
9/10 |
day1 (4M), day2 (5M) day 1 (3 F), day2 -14 (4F) |
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- Under the test conditions of this study, males were more sensitive than female rats. Therefore, based on the oral LD50 of male rats (= 982 mg/kg bw) considering as the worst case, 2-Methylglutaronitrile is considered in Category 3 (H311: Toxic in contact with skin) according to the Regulation 1272/2008 and as Harmful in contact with skin (Xn, R21) according to the Directive 67/548/EEC.
- Executive summary:
In an acute dermal toxicity study performed similarly to the OECD test guideline No. 402, Sprague-Dawley rats were exposed to 2 -methylglutaronitrile undiluted for 24 hours at doses of 0, 1000, 1100, 1500 and 2000 mg/kg bw. Animals then were observed for 14 days. Reduced activity, apathy, prostration, slight ptosis, slight tremor were observed in all treated animals.
Dermal LD50 male/female = 1154 mg/kg bw
Dermal LD50 male = 982 mg/kg bw
Dermal LD50 female = 1403 mg/kg bw
At equivalent dose level, mortality was more pronounced in males than in females. Under the test conditions of this study, males were more sensitive than female rats. Therefore, based on the oral LD50 of male rats considering as the worst case, 2-Methylglutaronitrile is considered in Category 3 (H311: Toxic in contact with skin) according to the Regulation 1272/2008 and as Harmful in contact with skin (Xn, R21) according to the Directive 67/548/EEC.
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