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EC number: 201-853-3 | CAS number: 88-72-2
- 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
Endpoint summary
Administrative data
Description of key information
The oral LD50 value ranged from 890 to 2546 mg/kg b.w. in rats
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Documentation insufficient for assessment
- Principles of method if other than guideline:
- Single oral dose toxicity was determined by the method of Smyth et al., Am. Ind. Hyg. Ass. J. 30, 470-476 (1962) in which the LD50 and its confidence limits are estimated by the moving average technique (Thompson WR, 1947, Bact Rev 11: 115-145; Weil C.1952, Biometrics 8. 249-263)
- GLP compliance:
- no
- Remarks:
- GLP was not mandatory at the time of the study
- Test type:
- acute toxic class method
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
-Weight at study initiation: 200-300g
-Diet: Purina Formulab Chow 5008 - Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Doses:
- Not reported
- No. of animals per sex per dose:
- Not reported
- Control animals:
- other: not applicable
- Statistics:
- Probit analysis
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 890 mg/kg bw
- 95% CL:
- 500 - 1 580
- Interpretation of results:
- Category 3 based on GHS criteria
- Executive summary:
Vernot (1977):
Single oral dose toxicity was determined by the method of Smyth et al., Am. Ind. Hyg. Ass. J. 30, 470-476 (1962) in which the LD50 and its confidence limits are estimated by the moving average technique (Thompson WR, 1947, Bact Rev 11: 115-145; Weil C.1952, Biometrics 8. 249-263)
LD50 was determined to be 890 mg/kg bw (95% CL: 500-1580).
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable deviations
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- No GLP. Fasting and acclimation period, and environmental conditions not reported. Animals weighed just the first days of the treatment. Body weights were not reported.
- GLP compliance:
- no
- Remarks:
- GLP was not mandatory at the time of the study
- Test type:
- standard acute method
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Evic-Ceba, 33290 Blanquefort, France
- Weight at study initiation: 200 g (average)
- Diet (e.g. ad libitum): Extralabo M25 Biscuits (Evic-Ceba, France) ad libitum
- Water (e.g. ad libitum): tap water ad libitum - Route of administration:
- oral: gavage
- Vehicle:
- other: olive oil
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 1 mL per 200 g bw
- Doses:
- 1000, 1500, 2000, 2500, 3000, 4000 mg/kg (males);
1000, 1500, 2000, 2500, 3000, 4000 mg/kg (female) - No. of animals per sex per dose:
- 10
- Control animals:
- other: not applicable
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The behavior and the symptomatology of the animals were observed every day
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, and body weight - Statistics:
- The calculation of the LD50 was performed according to the method of Miller and Tainter (Proc Soc Exp Biol Med, 1944, 57: 261-264), following the indications of Bartlett (Suppl I Rog Stat, 1937, 137-170)
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 2 100 mg/kg bw
- Mortality:
- The mortality was registered within 48 hours, otherwise the recovery is gradual
- Clinical signs:
- other: other: Soon after the administration of the test substance, the animals were shaking. The animals respiratory rythm was increased. They animals had seizure for short time
- Interpretation of results:
- Category 5 based on GHS criteria
- Executive summary:
Ciss (1980):
The acute toxicity of 2 -nitrotoluene was determinated by oral exposure (gavage) with a method similar to OECD 401 with deviations (No GLP. Fasting and acclimation period, and environmental conditions not reported. Animals weighed just the first days of the treatment. Body weights were not reported).
LD 50 resulted to be 2100 mg/kg bw. Mortality took place with 48 hours from the treatment.
Soon after the administration of the test substance, the animals were shaking. The animals respiratory rythm was increased. They animals had seizure for short time.
Referenceopen allclose all
Doses mg/kg |
Mortality |
Mortality rate |
||||||
|
hours |
days |
|
|||||
Male rats |
0-5 |
5-18 |
18-24 |
2 |
3 |
4-7 |
8-14 |
|
1000 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/10 |
1500 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
1/10 |
2000 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
5/10 |
2500 |
0 |
0 |
5 |
0 |
0 |
0 |
0 |
7/10 |
3000 |
0 |
0 |
6 |
0 |
0 |
0 |
0 |
8/10 |
4000 |
0 |
0 |
10 |
- |
- |
- |
- |
10/10 |
Female rats |
|
|
|
|
|
|
|
|
1000 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/10 |
1500 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
2/10 |
2000 |
0 |
0 |
4 |
0 |
0 |
0 |
0 |
4/10 |
2500 |
0 |
0 |
6 |
2 |
0 |
0 |
0 |
8/10 |
3000 |
0 |
0 |
8 |
0 |
0 |
0 |
0 |
8/10 |
4000 |
0 |
0 |
10 |
- |
- |
- |
- |
10/10 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 890 mg/kg bw
- Quality of whole database:
- The lowest LD50 value was selected as the dose descriptor for this endpoint.
Additional information
EU RISK ASSESSMENT 2008
The acute toxicity of 2-nitrotoluene has been investigated in rats and mice (inhalatory), rats and rabbits (dermal), and rats, mice and rabbits (oral).
The available studies on inhalatory toxicity have limited quality especially with respect to the identity of the test substance (purity not reported). However, because of results were similar they can be useful for risk assessment. At saturated vapour concentrations, 190.8 ppm (1.086 mg/L) for 8 h or 320 ppm (1.795 mg/L) for 4 h in rats and 354 ppm (1.986 mg/L) for 4 h in mice, 2-nitrotoluene, did not produce mortalities, toxicity and gross lesions within 14-day observation period. Therefore, according to the CLP criteria, no classification is necessary.
The available studies on dermal toxicity have limited quality especially with respect to the identity of the test substance (purity not reported). However, because of results were similar they can be useful for risk assessment. In a limit test, 2-nitrotoluene (5000 mg/kg b.w. in rats and 20000 mg/kg b.w. in rabbits) did not produce either mortality or toxicity within 14-day observation period. Therefore, according to the CLP criteria, no classification is necessary.
The available studies on acute oral toxicity have limited quality (only in one study purity was reported). However, because of results were similar they can be useful for risk assessment. The oral LD50 value ranged from 890 to 2546 mg/kg b.w. in rats, from 970 to 2462 mg/kg b.w. in mice and was determined to be 1750 mg/kg b.w in rabbit. Clinical signs of toxicity were related with methaemoglobin formation. Based on the lower oral LD50 value (890 mg/kg b.w in rats), according to the CLP criteria, 2-nitrotoluene is classified in the Category 4.
The reported effects in humans exposed by different routes are most likely due to methaemoglobin formation but data on acute toxicity (Goldblatt, 1955) are limited to inhalation exposure. However, since a NOAEC/LOAEC could not be determined as starting point for risk characterization for acute toxicity because the exposure duration was not reported. Therefore, the risk assessment for acute toxicity has been derived from animal data.
Justification for classification or non-classification
Harmonised classification:
The substance is classified in Category 4 (H302: Harmful if swallowed) according to the Regulation (EC) No. 1272/2008 (CLP).
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