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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
Endpoint summary
Administrative data
Description of key information
The substance Paracetamol was found to be irritating in skin and eye category.
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:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Qualifier:
- according to guideline
- Guideline:
- other:
- Principles of method if other than guideline:
- Skin irritation toxicity of acetaminophen (paracetamol)on rats
- GLP compliance:
- not specified
- Species:
- rat
- Strain:
- Fischer 344
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:Charles River Inc., Atsugi, Japan
- Age at study initiation:6 weeks
- Weight at study initiation:
- Diet (e.g. ad libitum):basal diet (Oriental M, Oriental Yeast Co., Tokyo)
- Water (e.g. ad libitum):tap water ad libitum - Type of coverage:
- not specified
- Preparation of test site:
- not specified
- Vehicle:
- not specified
- Controls:
- not specified
- Duration of treatment / exposure:
- week 32
- Number of animals:
- 40 animals ,four groups (five rats each)
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Reversibility:
- no data
- Remarks on result:
- other: Skin rashes have been reported
- Interpretation of results:
- moderately irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The paracetamol (acetaminophen) caused minimal irritation in rats at a concentration of 1.3%.,Skin rashes have been reported by paracetamol.
- Executive summary:
The paracetamol (acetaminophen) caused minimal irritation in rats at a concentration of 1.3%.,Skin rashes have been reported by paracetamol.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- (Q)SAR
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Justification for type of information:
- QSAR prediction: migrated from IUCLID 5.6
- Qualifier:
- according to guideline
- Guideline:
- other: Estimated data
- Principles of method if other than guideline:
- Prediction is done using QSAR Toolbox version 3.1
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- not specified
- Vehicle:
- not specified
- Controls:
- not specified
- Duration of treatment / exposure:
- 1 days
- Number of animals or in vitro replicates:
- 6
- Irritation parameter:
- other: MMAS(modified maximum average score (MMAS))
- Basis:
- mean
- Time point:
- other: 1 d
- Score:
- 30.8
- Reversibility:
- not specified
- Remarks on result:
- other: Irritation observed
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- By the modified maximum average score (MMAS) from QSAR eye irritation score of Paracetamol is estimated as 30.8. This score indicates that Paracetamol is irritating to the eyes of rabbit.(as the criteria MMAS ≤ 59 is irritating).
- Executive summary:
By the modified maximum average score (MMAS) from QSAR eye irritation score of Paracetamol is estimated as 30.8. This score indicates that Paracetamol is irritating to the eyes of rabbit.(as the criteria MMAS ≤ 59 is irritating).
Reference
The prediction was based on dataset comprised from the following descriptors: MMAS
Estimation method: Takes average value from the 5 nearest neighbours
Domain logical expression:Result: In Domain
(((("a" or "b" or "c" or "d" or "e" or "f" ) and ("g" and ( not "h") ) ) and "i" ) and ("j" and "k" ) )
Domain logical expression index: "a"
Referential boundary: The target chemical should be classified as Phenols (Acute toxicity) by US-EPA New Chemical Categories
Domain logical expression index: "b"
Referential boundary: The target chemical should be classified as Aryl AND Carboxamide AND Phenol AND Precursors quinoid compounds by Organic functional groups
Domain logical expression index: "c"
Referential boundary: The target chemical should be classified as Carboxamide AND Overlapping groups AND Precursors quinoid compounds by Organic functional groups (nested)
Domain logical expression index: "d"
Referential boundary: The target chemical should be classified as Alcohol, olefinic attach [-OH] AND Aliphatic Carbon [CH] AND Aliphatic Carbon [-CH2-] AND Aliphatic Carbon [-CH3] AND Aliphatic Nitrogen, one aromatic attach [-N] AND Amide, aliphatic attach [-C(=O)N] AND Aromatic Carbon [C] AND Carbonyl, aliphatic attach [-C(=O)-] AND Hydroxy, aromatic attach [-OH] AND Miscellaneous sulfide (=S) or oxide (=O) AND Nitrogen, two or tree olefinic attach [>N-] AND Olefinic carbon [=CH- or =C<] AND Oxygen, one aromatic attach [-O-] by Organic functional groups (US EPA)
Domain logical expression index: "e"
Referential boundary: The target chemical should be classified as Aromatic compound AND Carbonic acid derivative AND Carboxylic acid amide AND Carboxylic acid derivative AND Carboxylic acid sec. amide AND Hydroxy compound AND Phenol by Organic functional groups, Norbert Haider (checkmol)
Domain logical expression index: "f"
Referential boundary: The target chemical should be classified as Group 14 - Carbon C AND Group 15 - Nitrogen N AND Group 16 - Oxygen O by Chemical elements
Domain logical expression index: "g"
Referential boundary: The target chemical should be classified as No alert found by Protein binding by OASIS v1.1
Domain logical expression index: "h"
Referential boundary: The target chemical should be classified as Acylation OR Acylation >> Direct acylation involving a leaving group OR Acylation >> Direct acylation involving a leaving group >> N-acylamides OR Acylation >> Direct acylation involving a leaving group >> N-acylsulphonamides by Protein binding by OASIS v1.1
Domain logical expression index: "i"
Similarity boundary:Target: c1(O)ccc(NC(C)=O)cc1
Threshold=10%,
Dice(Atom centered fragments)
Domain logical expression index: "j"
Parametric boundary:The target chemical should have a value of log Kow which is >= -4.99
Domain logical expression index: "k"
Parametric boundary:The target chemical should have a value of log Kow which is <= 4.05
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
No. of studies were reviewed for skin irritation from reliable sources having Klimisch rating 2 .
The summary of the results are presented below
By applying weight of evidence approach to the target substance Paracetamol ,it is concluded that the substance is irritating to the eyes of rabbit and mouse.
Minimal irritation was observed after administration of 1.3% acetaminophen as reportgiven by Tsuca et.al (Carcinogenesis (London) 1988, 9(4), 547-554).Similarly the QSAR prediction estimated the irritation score to be 1.78% indicating it to be skin irritant
By applying weight of evidence approach to the target substance Paracetamol,it is concluded that the substance is irritating to the skin of rabbit.
Eye irritation
No. of studies were reviewed for eye irritation from reliable sources having Klimisch rating 2 and 4.
The summary of the results are presented below
Sr.No |
Irritation Parameter |
Interpretation of results |
Species |
Sources |
1 |
MMAS(modified maximum average score (MMAS)) |
Irritating |
Rabbit |
Predicted data from QSAR |
2 |
Overall irritation score |
Irritating |
Mouse |
Handbook data |
3 |
Overall irritation score |
Moderately Irritating |
Rabbit |
Publication data for Read across |
By applying weight of evidence approach to the target substance Paracetamol ,it is concluded that the substance is irritating to the eyes of rabbit and mouse
Justification for selection of skin irritation / corrosion endpoint:
The paracetamol (acetaminophen) caused minimal irritation in rats at a concentration of 1.3%.,Skin rashes have been reported by paracetamol.
Justification for selection of eye irritation endpoint:
By the modified maximum average score (MMAS) from QSAR eye irritation score of Paracetamol is estimated as 30.8. This score indicates that Paracetamol is irritating to the eyes of rabbit.(as the criteria MMAS ≤ 59 is irritating).
Effects on skin irritation/corrosion: moderately irritating
Effects on eye irritation: irritating
Justification for classification or non-classification
The available studies indicate that the substance Paracetamol is classified as a skin and eye irritant according to CLP regulation.
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.
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