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EC number: 202-808-0 | CAS number: 99-99-0
- 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: not a skin irritant (eq. OECD TG 404, GLP, Key, rel.1).
Eye irritation: not an eye irritant (eq. OECD TG 405, GLP, Key, rel.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:
- From 18.03. 1986 To 21.03.1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG, Kastengrund, Germany, conventional breeding
- Age at study initiation: 3-5 months
- Weight at study initiation: 2.2-2.9 kg
- Housing: in air conditioned room, in single cage
- Diet (e.g. ad libitum): Altromin 2123 rabbit breeding diet (Altromin GmbH, Lage/Lippe) as well as hay ad libitum
- Water (e.g. ad libitum): deionised, chlorinated water from automatic drinking trough ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 50 ± 20%
- Photoperiod (hrs dark / hrs light): 12 hrs dark/ 12 hrs light - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: Polyethylene glycol 400
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg Test substance was moistened with 0.2 ml polyethylene glycol 400
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.2 mL Polyethylenglycol 400
- Lot/batch no. (if required): Ch-B 2322, Fa Riedel de Haen AG, Germany - Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- up to 72 hours
- Number of animals:
- 3
- Details on study design:
- 24 hours before start of the experiment rabbits were shaved at the dorsal region of the trunk (area 25 cm², intact skin). 500 mg test substance was moistened with 0.2 ml polyethylene glycol 400 and applied on a special tape with additional gauze (area: 2.5 cm²). This tape was fixed on the shaved area and covered by a semiocclusive dressing for 4 hours. After this time tape and test substance were carefully removed from the skin with lukewarm water. Reading were performed as follows: 30-60 min, 24, 48 and 72 hours after removing of the tape, according to DRAIZE score
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Executive summary:
Hofmann (Hoechst AG, 1986)
4-Nitrotoluene, moistened with polyethylene glycol 400, was not irritating to the skin of rabbits, when applied under semi-occlusive condition for four hours according to OECD 404.
The mean Draize scores for edema and erythema were each "0".
4-Nitrotoluene is not irritating to the skin of rabbits.
Reference
Readings | 24 h | 48 h | 72h | Average animal 1 (24 -72 h) | Average animal 2 (24 -72 h) | Average animal 3 (24 -72 h) | Total average | ||||||
Animals | 1 | 2 | 3 | 1 | 2 | 3 | 1 | 2 | 3 | 1 | 2 | 3 | - |
Erythema | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Odema | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
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
- Study period:
- From: 18/03/1986 To: 21/03/1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG, Kastengrund, Germany. Conventional breeding
- Age at study initiation: 3-5 months
- Weight at study initiation: 2.7-3.7 kg
- Housing: the animals were housed in individual cages in air conditioned room
- Diet (e.g. ad libitum): Altromin 2123 Haltungsdiät-Kaninchen (Altromin GmbH, Lage/Lippe, Germany) and hay as well
- Water (e.g. ad libitum): deionised and chlorinated water from automatic drinking trough
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/-3 °C
- Humidity (%):50+/-20 %
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light
IN-LIFE DATES: From: 18/03/1986 To: 21/03/1986 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye served as control
- Amount / concentration applied:
- Amount applied: 100 mg
- Duration of treatment / exposure:
- 24 hour(s)
- Observation period (in vivo):
- 24, 48, and 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF THE TEST SUBSTANCE
Washing (if done): yes, with physiologic saline solution
- Time after start of exposure: at 24 hours after exposure, and at all the other time points. The washing was performed also when excretions were observed in the treate eyes and when the fluorescein test was performed on the cornea of the treated eyes.
SCORING SYSTEM: Draize Method
TOOL USED TO ASSESS SCORE: fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- One hour post exposure all the animals presented a light and whit discharge. The conjunctiva was swollen in all the animals and showed a clear hyperaemia of the vasculature.
24 hours post exposure the animals showed still a clear hyperaemia of the vasculature up to carmine red coloration of the conjunctiva.
The effect described above were completely reversible within 48 hours.
One hour post exposure all the animals presented a light and whit discharge. The conjunctiva was swollen in all the animals and showed a clear hyperaemia of the vasculature.
24 hours post exposure the animals showed still a clear hyperaemia of the vasculature up to carmine red coloration of the conjunctiva.
The effects described above were completely reversible within 48 hours. - Executive summary:
Hofmann T (1986)
In a test according to OECD TG 405, 100 mg of 4-nitrotoluene was applied into the conjunctival sac of the left eye of each of three rabbits. 24 hours later the eyes were rinsed. One hour post exposure all the animals presented a light and whit discharge. The conjunctiva was swollen in all the animals and showed a clear hyperaemia of the vasculature.
24 hours post exposure the animals showed still a clear hyperaemia of the vasculature up to carmine red coloration of the conjunctiva.
The effects described above were completely reversible within 48 hours.
4-Nitrotoluene is not irritating to the eyes of rabbits.
Reference
Timeendpoint after application | 24h | 48h | 72h | Average (24-72 h)animal 1 | Average (24-72h) animal 2 | Average(24-72 h)animal 3 | Total average | ||||||
Animal number | 1 | 2 | 3 | 1 | 2 | 3 | 1 | 2 | 3 | 1 | 2 | 3 | - |
Conjuctiva: Chemosis | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Conjuctiva: redness | 1 | 2 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0.3 | 0.7 | 0.3 | 0.4 |
Iris | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Corneal opacity | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Fluoresceintest | 0 | 0 | 0 |
|
|
| 0 | 0 | 0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation:
A key study is available. 4-nitrotoluene was applied undiluted to clipped intact areas of the skin which had been pre-softened with Polyethylenglycol 400, using a method equivalent to OECD guideline 404 (semi-occlusive coverage, 4h exposure duration, GLP).
Treatment with 4-nitrotoluene: the test substance produced no erythema or edema at any time point of measurement (24/48/72h).
Mean individual erythema scores (24/48/72 h): 0.0 / 0.0 / 0.0
Mean individual edema scores (24/48/72 h): 0.0 / 0.0 / 0.0
Eye irritation:
A key study is identified. The skin irritation of 2-nitrotoluene has been investigated in a GLP compliant study according to OECD guideline 405 / EU B.5 with no deviations.
The individual scores (24/48/72 h) were the following:
- Cornea score: 0.0 / 0.0 / 0.0;
- Conjunctiva score: 0.3 / 0.7 / 0.3 (fully reversible within 48 h);
- Iris score: 0.0 / 0.0 / 0.0 / 0.0 / 0.0 / 0.0;
- Chemosis score: 0.0 / 0.0 / 0.0 / 0.0 / 0.0 / 0.0.
Justification for classification or non-classification
Harmonised classification:
The substance has no harmonised classification for irritation / corrosion according to the Regulation (EC) No. 1272/2008 (CLP).
Self classification:
Based on the available information no additional self-classification is proposed regarding both skin and eye irritation according to the CLP and to the GHS.
No data was available regarding respiratory irritation, however the substance not being classified for skin and eye irritation, no classification is expected for respiratory irritation.
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