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EC number: 204-289-6 | CAS number: 118-96-7
- 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
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- Oxidising properties
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- Stability: thermal, sunlight, metals
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- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
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- Endpoint summary
- Stability
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- 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
Key value for chemical safety assessment
Effects on fertility
Description of key information
Lowest NOAEL for female is 4.5 mg/kg bw/day (oral, rat) = 75 mg/kg diet ( Birth weight of the offspring)
Lowest NOAEL for male is 300 mg/kg diet (decrease in properly motile spermatozoa (live) number in the parental and F1 generation)
(15,73 mg TNT/kg of feed/24h in case of parental generation and 26,94 mg TNT/kg body weight/24h in case of second generation F1)
The classification as Repr. 2, H361f is regarded as inappropriate since:
- No statistically significant effect on female oestrous cyclicity or estrogen cycle length was found
- No pathological pregnancy was observed, no abnormalities during delivery or increased neonatal deaths during delivery, feeding and adolescence
- No abnormalities in the structure of the gonads and their microscopic image were observed in both females and males of parental and second generations. There were no signs of degenerative, inflammatory, cancerous changes within the reproductive organs that could affect their ability to reproduce
- A significant reduction in the number of correctly motile spermatozoa was found in the 1200 mg TNT/kg feed males dosed in parental generation by 11.51%. Despite the decrease in this parameter, the sperm quality was sufficient for 100% fertilization efficiency in the group.
- The test item did not affect the length of pregnancy.
Link to relevant study records
- Endpoint:
- extended one-generation reproductive toxicity - with developmental neurotoxicity (Cohorts 1A, 1B without extension, 2A and 2B)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 443 (Extended One-Generation Reproductive Toxicity Study)
- Deviations:
- yes
- Remarks:
- The test parameters: 19-25°C, relative humidity 30-70%. During the experiment: lowest temp. 18.70°C; highest 25.10°C; highest humidity 71%. These were short-term deviations and did not affect the course of the study or the reliability of the results.
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Route of administration:
- oral: feed
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 75 mg/kg diet
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- reproductive performance
- Remarks on result:
- other: 4,50 mg TNT/kg body weight/24h – average dose for mothers in pregnancy period
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 300 mg/kg diet
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- reproductive function (sperm measures)
- Remarks on result:
- other: 15,73 mg TNT/kg of feed/24h in case of parental generation and 26,94 mg TNT/kg body weight/24h in case of second generation F1
- Dose descriptor:
- NOAEL
- Effect level:
- 300 mg/kg diet
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- Remarks on result:
- other: 15,73 mg TNT/kg body weight/24h – males; 22,94 mg TNT/kg body weight/24h – females
- Dose descriptor:
- NOAEL
- Effect level:
- 300 mg/kg diet
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- food consumption and compound intake
- Remarks on result:
- other: 15,73 mg TNT/kg body weight/24h
- Dose descriptor:
- NOAEL
- Effect level:
- < 75 mg/kg diet
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- haematology
- Dose descriptor:
- NOAEL
- Generation:
- F1 (cohort 1A)
- Effect level:
- 300 mg/kg diet
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- Remarks on result:
- other: 26,94 mg TNT/kg body weight/24h – males; 26,15 mg TNT/kg body weight/24 h - females
- Dose descriptor:
- NOAEL
- Generation:
- F1 (cohort 1B)
- Effect level:
- < 75 mg/kg diet
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- body weight and weight gain
- Remarks on result:
- other: <7,14 mg TNT/kg body weight/24h
- Dose descriptor:
- NOAEL
- Generation:
- F1 (cohort 2A)
- Effect level:
- < 75 mg/kg diet
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- Remarks on result:
- other: 7,72 mg TNT/kg body weight/24h – males; 7,14 mg TNT/kg body weight /24 h – females
- Dose descriptor:
- NOAEL
- Generation:
- F1 (cohort 2B)
- Effect level:
- 300 mg/kg diet
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- Remarks on result:
- other: 26,94 mg TNT/kg body weight/24h – males; 26,15 mg TNT/kg body weight/24 h – females
- Reproductive effects observed:
- not specified
Reference
NOAEL and LOAEL values were defined for parameters:
- Amount of feed consumed by parental generation in male group:
NOAEL – 300 mg TNT/kg of feed (15,73 mg TNT/kg body weight/24h)
LOAEL – 1200 mg TNT/kg of feed (70,09 mg TNT/kg body weight/24h).
- Body weight of parental generation animals in female and male group:
NOAEL – 300 mg TNT/kg of feed (15,73 mg TNT/kg body weight/24h – males; 22,94 mg TNT/kg body weight/24h – females)
LOAEL – 1200 mg TNT/kg of feed (70,09 mg TNT/kg body weight/24h – males; 81,96 mg TNT/kg body weight/24h – females).
- Body weight of F generation, cohort 1A in female and male group:
NOAEL – 300 mg TNT/kg of feed (26,94 mg TNT/kg body weight/24h – males; 26,15 mg TNT/kg body weight/24 h - females)
LOAEL – 1200 mg TNT/kg of feed (105,63 mg TNT/kg body weight/24h – males; 101,85 mg TNT/kg body weight/24 h - females).
- Body weight of F generation, cohort 1B in females and male group:
NOAEL < 75 mg TNT/kg of feed (<7,14 mg TNT/kg body weight/24h)
LOAEL < 75 mg TNT/kg of feed (7,14 mg TNT/kg body weight/24h) in case of females
NOAEL – 75 mg TNT/kg of feed (7,72 mg TNT/kg body weight/24h)
LOAEL – 300 mg TNT/kg of feed (26,94 mg TNT/kg body weight/24h) in case of males.
- Body weight of F generation, cohort 2A in female and male group:
NOAEL, LOAEL < 75 mg TNT/kg of feed (7,72 mg TNT/kg body weight/24h – males; 7,14 mg TNT/kg body weight /24 h – females).
- Body weight of F generation, cohort 2B in female and male group:
NOAEL – 300 mg TNT/kg of feed (26,94 mg TNT/kg body weight/24h – males; 26,15 mg TNT/kg body weight/24 h – females).
LOAEL – 1200 mg TNT/kg of feed (105,63 mg TNT/kg body weight/24h – males; 101,85 mg TNT/kg body weight/24 h – females.
- Birth weight of the offspring:
NOAEL – 75 mg TNT/kg of feed (4,50 mg TNT/kg body weight/24h – average dose for mothers in pregnancy period) in case of females
LOAEL – 300 mg TNT/kg of feed (16,33 mg TNT/kg body weight/24h – average dose for mothers in pregnancy period) in case of females
NOAEL – 300 mg TNT/kg of feed (16,33 mg TNT/kg body weight/24h – average dose for mothers in pregnancy period) in case of males mothers in pregnancy period) in case of females
LOAEL – 1200 mg TNT/kg of feed (61,20 mg TNT/kg body weight/24h – average dose for mothers in pregnancy period) in case of males.
- Sperm parameters – decrease in properly motile spermatozoa (live) number in the parental and F1 generation:
NOAEL – 300 mg TNT/kg of feed (15,73 mg TNT/kg of feed/24h in case of parental generation and 26,94 mg TNT/kg body weight/24h in case of second generation F1)
LOAEL – 1200 mg TNT/kg of feed (70,09 mg TNT/kg of feed/24h in case of parental generation and 105,63 mg TNT/kg body weight/24h in case of second generation F1).
- Forelimb grip strength:
NOAEL – 300 mg TNT/kg of feed (26,94 mg TNT/kg body weight/24h – males; 26,15 mg TNT/kg body weight/24 h – females)
LOAEL – 1200 mg TNT/kg of feed (105,63 mg TNT/kg body weight/24h – males; 101,85 mg TNT/kg body weight/24 h – females).
- Number of erythrocytes, females and males parental generation:
NOAEL, LOAEL < 75 mg TNT/kg of feed (<4,51 mg TNT/kg body weight/24h – males; <6,74 mg TNT/kg body weight/24h – females).
- Number of erythrocytes, females and males F1 generation, cohort 1A:
NOAEL – 75 mg TNT/kg of feed (7,14 mg TNT/kg body weight/24h) in case of females
LOAEL – 300 mg TNT/kg of feed (26,15 mg TNT/kg body weight/24h) in case of females
NOAEL – 300 mg TNT/kg of feed (26,94 mg TNT/kg body weight/24h) in case of males
LOAEL – 1200 mg TNT/kg of feed (105,63 mg TNT/kg body weight/24h) in case of males.
- Haemoglobin concentration, females and males parental generation:
NOAEL, LOAEL < 75 mg TNT/kg of feed (<4,51 mg TNT/kg body weight/24h – males; <6,74 mg TNT/kg body weight/24h – females).
- Haemoglobin concentration, females and males cohort 1A, F1 generation:
NOAEL – 300 mg TNT/kg of feed (26,15 mg TNT/kg body weight/24h) in case of females
LOAEL – 1200 mg TNT/kg of feed (101,85 mg TNT/kg body weight in case of females
NOAEL – 75 mg TNT/kg of feed (7,72 mg TNT/kg body weight/24h) in case of males
LOAEL – 300 mg TNT/kg of feed (26,94 mg TNT/kg body weight) in case of males.
- Haematocrit, males and females parental generation:
NOAEL, LOAEL < 75 mg TNT/kg of feed (<4,51 mg TNT/kg body weight/24h – males; <12,15 mg TNT/kg body weight/24h – females).
- Haematocrit, females and males cohort 1A, F1 generation:
NOAEL – 300 mg TNT/kg of feed (26,94 mg TNT/kg body weight/24h)
LOAEL – 1200 mg TNT/kg of feed (105,63 mg TNT/kg body weight/24h) in case of males – no dose dependence for females.
- Average haemoglobin concentration in erythrocytes (MCHC) in case of F1 generation males:
NOAEL – 75 mg TNT/kg of feed (7,72 mg TNT/kg body weight/24h)
LOAEL – 300 mg TNT/kg of feed (26,94 mg/kg body weight).
- Number of granulocytes (decrease):
NOAEL – 75 mg TNT/kg of feed (4,51 mg TNT/kg body weight/24h) in case of males of parental generation
LOAEL – 300 mg TNT/kg of feed (15,73 mg TNT/kg body weight/24h) in case of males of parental generation
NOAEL – 300 mg TNT/kg of feed (26,15 mg TNT/kg body weight/24h) in case of females of F1 generation, cohort 1A
LOAEL – 1200 mg TNT/kg of feed (101,85 mg TNT/kg body weight/24h) in case of females of F1 generation, cohort 1A.
- Number of granulocytes with segmented nuclei (decrease):
NOAEL, LOAEL < 75 mg TNT/kg of feed (<4,51 mg/kg body weight /24h) in case of males of parental generation
NOAEL – 300 mg TNT/kg of feed (26,15 mg TNT/kg body weight/24h) in case of females of F1 generation, cohort 1A
LOAEL – 1200 mg TNT/kg of feed (101,85 mg/kg body weight /24h) in case of females of F1 generation, cohort 1A.
- Activated partial thromboplastin time (APTT) parental generation:
NOAEL, LOAEL < 75 mg TNT/kg of feed (<4,51 mg TNT/kg body weight/24h – males; <6,74 mg TNT/kg body weight/24h – females).
- Alanine aminotransferase (activity decrease) in case of females of parental generation:
NOAEL – 75 mg TNT/kg of feed (6,74 mg TNT/kg body weight/24h)
LOAEL – 300 mg TNT/kg of feed (22,94 mg TNT/kg body weight/24h).
- Aspartic aminotransferase (activity decrease) for cohort 1A males and females of F1 generation:
NOAEL – 300 mg TNT/kg of feed (26,94 mg TNT/kg body weight/24h – males; 26,15 mg TNT/kg body weight/24 h – females)
LOAEL – 1200 mg TNT/kg of feed (105,63 mg TNT/kg body weight/24h – males; 101,85 mg TNT/kg body weight/24 h – females).
- Globulins (concentration decrease) in F1 generation males, cohort 1A:
NOAEL – 300 mg TNT/kg of feed (26,94 mg TNT/kg body weight/24h)
LOAEL – 1200 mg TNT/kg of feed (105,63 mg TNT/kg body weight/24h).
- Cholesterol (concentration decrease) in parental generation males:
NOAEL, LOAEL < 75 mg TNT/kg of feed (<4,51 mg TNT/kg body weight/24h)
- Creatinine (concentration decrease) in F1 generation males, cohort 1A:
NOAEL – 75 mg TNT/kg of feed (7,72 mg TNT/kg body weight/24h)
LOAEL – 300 mg TNT/kg of feed (26,94 mg TNT/kg body weight/24h).
- Sodium – concentration of sodium decrease: NOAEL – 75 mg TNT/kg feed – females F1 generation, cohort 1A:
NOAEL – 75 mg TNT/kg of feed (7,14 mg TNT/kg body weight/24h)
LOAEL – 300 mg TNT/kg of feed (26,15 mg TNT/kg body weight/24h).
Effect on fertility: via oral route
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 4.5 mg/kg bw/day
- Species:
- rat
- Quality of whole database:
- Klimisch rating 1.
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Effects on developmental toxicity
Description of key information
Taking into account the results of studies on rats and rabbits the classification of 2,4,6-trinitrotolene as reproductive toxicant is needed.
According to the obtained results of studies on rats, 2,4,6-trinitrotoluene has an adverse effect on developmental toxicity in laboratory animals manifesting high intrauterine mortality and decreased foetal body weight by the presence of doses in which maternal toxicity is also found. It should be noted that the fetotoxicity of the test substance was also observed when the applied doses (10 mg/kg bw and 45 mg/kg bw) were non-toxic for mothers.
Whereas, the results of the study on rabbits indicate that the embryotoxicity of the tested substance 2,4,6-trinitrotolene occurs at a maternal toxic dose of 160 mg / kg (fewer live foetuses), and fetotoxicity even at a maternally non-toxic dose of 10 mg / kg b.w. as evidenced by lower body weight of male foetuses than in the control in the offspring of females from all groups exposed.
It was indicated, that the ossification delays were also found at a dose of 160 mg /kg body weight. However, no malformations of the soft tissues and skeletal system were observed. There were no malformations in the offspring of exposed females, which indicates that 2,4,6-trinitrotolene is not a teratogenic substance.
Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Version / remarks:
- Oral route, rat or rabbit
- Deviations:
- yes
- Remarks:
- In the Study plan, it was assumed female fertilisation by insemination, however in the premilinary stage of the test it was decided to introduce fertilization by method of male mating. The change does not affectthe test results.
- Species:
- rabbit
- Strain:
- New Zealand White
- Route of administration:
- oral: gavage
- Dose descriptor:
- LOAEL
- Effect level:
- 45 mg/kg bw/day
- Basis for effect level:
- food consumption and compound intake
- water consumption and compound intake
- Dose descriptor:
- LOAEL
- Effect level:
- > 160 mg/kg bw/day
- Basis for effect level:
- body weight and weight gain
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 10 mg/kg bw/day
- Basis for effect level:
- food consumption and compound intake
- water consumption and compound intake
- Abnormalities:
- effects observed, treatment-related
- Localisation:
- uterus
- Description (incidence and severity):
- the weight of the pregnant uterus showed a statistically significant decrease of 39.5% compared to the control group in the case of animals in the 160 mg/kg b.w.
- Dose descriptor:
- LOAEL
- Effect level:
- 160 mg/kg bw/day
- Basis for effect level:
- other: Viable fetuses
- Dose descriptor:
- NOAEL
- Effect level:
- 45 mg/kg bw/day
- Basis for effect level:
- other: Viable fetuses
- Dose descriptor:
- LOAEL
- Effect level:
- > 160 mg/kg bw/day
- Basis for effect level:
- other: Number of corpora lutea
- Dose descriptor:
- LOAEL
- Effect level:
- > 160 mg/kg bw/day
- Basis for effect level:
- other: Average number of embryonic deaths
- Dose descriptor:
- LOAEL
- Effect level:
- 45 mg/kg bw/day
- Sex:
- male/female
- Basis for effect level:
- fetal/pup body weight changes
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 10 mg/kg bw/day
- Sex:
- male/female
- Basis for effect level:
- fetal/pup body weight changes
- Abnormalities:
- effects observed, non-treatment-related
- Localisation:
- other: Developmental alterations in osteochondral system
- Description (incidence and severity):
- Parcial or no ossification of 5 bones of sternum and xiphoid cartilage
- Abnormalities:
- no effects observed
- Localisation:
- other: Developmental defects in osteochondral system
- Abnormalities:
- no effects observed
- Localisation:
- other: Changes in soft tissue and encephalon
- Key result
- Developmental effects observed:
- no
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Version / remarks:
- Oral route, rat or rabbit
- Species:
- rat
- Strain:
- Wistar
- Route of administration:
- oral: gavage
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 45 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: na
- Dose descriptor:
- LOAEL
- Effect level:
- 160 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- organ weights and organ / body weight ratios
- Dose descriptor:
- LOAEL
- Effect level:
- 10 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- fetal/pup body weight changes
- Abnormalities:
- not specified
- Developmental effects observed:
- yes
- Lowest effective dose / conc.:
- 10 mg/kg bw/day
- Treatment related:
- yes
- Relation to maternal toxicity:
- not specified
- Dose response relationship:
- yes
- Relevant for humans:
- not specified
Referenceopen allclose all
As no developmental disorders were found, this may suggest a mechanism related to maternal toxicity of the 2,4,6-trinitrotoluene.
- reduction in feed intake (statistically significant decrease compared to the control group) and water was observed at the exposure level of 160 mg/kg b.w. and 250 mg/kg b.w.
- maternal weight reduction and increase of methaemoglobin in a statistically significant differences were observed at the 160 mg/kg b.w. and 250 mg/kg b.w. dose levels.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 45 mg/kg bw/day
- Experimental exposure time per week (hours/week):
- 3
- Species:
- rat
- Quality of whole database:
- Klimisch rating 1.
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
According to the obtained results of studies on rats, 2,4,6-trinitrotoluene has an adverse effect on developmental toxicity in laboratory animals manifesting high intrauterine mortality and decreased foetal body weight by the presence of doses in which maternal toxicity is also found. It should be noted that the fetotoxicity of the test substance was also observed when the applied doses (10 mg/kg bw and 45 mg/kg bw) were non-toxic for mothers.
Whereas, the results of the study on rabbits indicate that the embryotoxicity of the tested substance 2,4,6-trinitrotolene occurs at a maternal toxic dose of 160 mg / kg (fewer live foetuses), and fetotoxicity even at a maternally non-toxic dose of 10 mg / kg b.w. as evidenced by lower body weight of male foetuses than in the control in the offspring of females from all groups exposed.
It was indicated, that the ossification delays were also found at a dose of 160 mg /kg body weight. However, no malformations of the soft tissues and skeletal system were observed. There were no malformations in the offspring of exposed females, which indicates that 2,4,6-trinitrotolene is not a teratogenic substance.
Taking into account the above results of studies on rats and rabbits the classification of 2,4,6-trinitrotolene as reproductive toxicant is needed. Nevertheless for classification in category 1B the available data must allow “a strong presumption that the substance has the capacity to interfere with reproduction in humans.” The results obtained from the studies on two species (rat and rabbit) are not strong enough to classify the substance as Category 1B.
Therefore, due to the fact that there is evidence of developmental toxicity of 2,4,6-trinitrotoluene, it is more appropriate and justified to classify this substance as Category 2 (H361d: Suspected of damaging the unborn child). This classification accommodates for both the positive findings in laboratory animals and the absence of significant effects in humans.
Therefore, the classification for 2,4,6-trinitrotoluene in the reproductive toxicity class is as follows:
Repr. 2 H361d Suspected of damaging the unborn child
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.