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EC number: 203-157-5 | CAS number: 103-90-2
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other:
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Neonatal paracetamol poisoning: treatment by exchange transfusion
- Author:
- S Lederman, W J Fysh, M Tredger, And H R Gamsu
- Year:
- 1 983
- Bibliographic source:
- Archives of Disease in Childhood. 58,631,1983
- Reference Type:
- review article or handbook
- Title:
- RTECS Number : AE4200000
- Author:
- RTECS database
- Year:
- 2 012
- Bibliographic source:
- RTECS (Registry of Toxic Effects of Chemical Substances):ADCHAK Archives of Disease in Childhood. (British Medical Journal, POB 560B, Kennebunkport, ME 04046) V.1- 1926- Volume(issue)/page/year: 58,631,1983
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other:
- Principles of method if other than guideline:
- The toxicity of paracetamol on Neonatal children during a study period of 29 weeks
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Paracetamol
- EC Number:
- 203-157-5
- EC Name:
- Paracetamol
- Cas Number:
- 103-90-2
- Molecular formula:
- C8H9NO2
- IUPAC Name:
- .
- Details on test material:
- - Name of test material (as cited in study report): Paracetamol
- Substance type: Organic
- Physical state: Solid
Constituent 1
Test animals
- Species:
- other: Human-woman
Administration / exposure
- Route of administration:
- oral: unspecified
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 29 week(s) after conception
Doses / concentrations
- Remarks:
- Doses / Concentrations:
500 mg/kg
Basis:
- No. of animals per sex per dose:
- 22 year old Caucasian mother
- Control animals:
- not specified
Examinations
- Maternal examinations:
- The mother had a toxic blood concentration of paracetamol.4 She had no clinical signs of liver damage after delivery, but 50 hours after the ingestion of paracetamol her aspartate transaminase activity rose to a maximum of 4300 IU/l, bilirubin to 30 [±mol/l (1 .75 mg/100 ml) and prothrombin time to 22 seconds .
- Fetal examinations:
- - There were no malformations.The Apgar scores were 4 at 1 minute and 7 at 5 minutes
- She subsequently developed hyaline membrane disease
- Clinical jaundice was apparent on day 5 with a bilirubin value of 180 .tmol/l
- Urinary reducing substances were negative.The aspartate transaminase was 86 IU/l, bilirubin 37 ,umol/l (2.2 mg/100 ml), and prothrombin time 28 seconds (control 13). She underwent exchange transfusionswith whole donor blood at 4, 23, 28, and 41 hours after delivery
- Examination of th cerebrospinal fluid and examination of the blood culture did not show infection
- She died unexpectedly at the age of 106 days. - Historical control data:
- The post mortem examination showed no definite cause of death, the only positive findings being many petechiae on the surface of the thymus, heart, and lungs.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- The mother had a toxic blood concentration of paracetamol.4 She had no clinical signs of liver damage after delivery, but 50 hours after the ingestion of paracetamol her aspartate transaminase activity rose to a maximum of 4300 IU/l, bilirubin to 30 [±mol/l (1 .75 mg/100 ml) and prothrombin time to 22 seconds .
- There were no malformations.The Apgar scores were 4 at 1 minute and 7 at 5 minutes
- She subsequently developed hyaline membrane disease
- Clinical jaundice was apparent on day 5 with a bilirubin value of 180 .tmol/l
- Urinary reducing substances were negative.The aspartate transaminase was 86 IU/l, bilirubin 37 ,umol/l (2.2 mg/100 ml), and prothrombin time 28 seconds (control 13). She underwent exchange transfusionswith whole donor blood at 4, 23, 28, and 41 hours after delivery
- Examination of th cerebrospinal fluid and examination of the blood culture did not show infection
- She died unexpectedly at the age of 106 days.
Effect levels (maternal animals)
- Dose descriptor:
- LOAEL
- Effect level:
- 500 other: mg/kg
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
Maternal abnormalities
- Abnormalities:
- not specified
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:yes
Details on embryotoxic / teratogenic effects:
hyaline membrane disease and decreased in bilirubin value was observed.
Effect levels (fetuses)
- Remarks on result:
- not measured/tested
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- In a chronic study of 29 weeks, LOAEL (Lowest observed effect level) for developmental toxicity of Paracetamol in human by the oral route was observed to be 500 mg/kg.
- Executive summary:
In this study report a case of paracetamol poisoning in an infant of 29 weeks' gestation whose mother ingested paracetamol before delivery.The baby girl, birthweight 1.22 kg (25th centile), was born by spontaneous vertex delivery,There were no malformations .She subsequently developed hyaline membrane disease,The bilirubin value fell to 90 Fmol/l (5.2 mg/100 ml) by day 8 and the jaundice was attributed to her prematurity,Examination of the cerebrospinal fluid and examination of the blood culture did not show infection.Plasma paracetamol concentrations did not decrease continuously in the infant but showed a rebound effect after each of the first 3 exchange transfusions.Thus we can conclude that the developmental toxicity study LOAEL (Lowest observed toxic dose) of Paracetamol in human by the oral route was observed to be 500 mg/kg in a chronic study of 29 weeks.
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