Paracetamol

Repeated dose toxicity: inhalation

Administrative data

Endpoint:

sub-chronic toxicity: inhalation

Type of information:

(Q)SAR

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Justification for type of information:

QSAR prediction: migrated from IUCLID 5.6

Data source

Reference

Reference Type:

other: Predicted data

Title:

[R]: 66.2 mg/m³ air; Estimation for NOAEC for CAS 103-90-2

Author:

Sustainability Support Services (Europe) AB

Year:

2013

Bibliographic source:

QSAR Toolbox version 3.1

Materials and methods

Test guideline

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

Test material

Test material information

Constituent 1

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: Paracetamol
- Substance type: Organic
- Physical state: Solid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Administration / exposure

Route of administration:

inhalation

Type of inhalation exposure:

whole body

Vehicle:

not specified

Duration of treatment / exposure:

28 days

No. of animals per sex per dose:

5

Control animals:

not specified

Results and discussion

Effect levels

Dose descriptor:

NOAEC

Effect level:

66.208 mg/kg bw/day (actual dose received)

Based on:

test mat.

Sex:

male/female

Basis for effect level:

other: No effects was observed.

Target system / organ toxicity

Critical effects observed:

not specified

Any other information on results incl. tables

The prediction was based on dataset comprised from the following descriptors: NOAEC
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 "h" )  )

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"

Parametric boundary:The target chemical should have a value of log Kow which is >= -2.36

Domain logical expression index: "h"

Parametric boundary:The target chemical should have a value of log Kow which is <= 2.68

Applicant's summary and conclusion

Conclusions:

The subchronic repeated dose toxicity NOAEC ( No observed adverse effect concentration) of Paracetamol to Wistar rats by inhalation route was observed at a dose concentration of 66.208 mg/m³ air in a 28 days study period.Thus it is concluded that the test substance Paracetamol is non toxic by repeated dose exposure within the concentration level mentioned.

Executive summary:

The subchronic repeated dose toxicity NOAEC ( No observed adverse effect concentration) of Paracetamol to Wistar rats by inhalation route was observed at a dose concentration of 66.208 mg/m³ air in a 28 days study period.Thus it is concluded that the test substance Paracetamol is non toxic by repeated dose exposure within the concentration level mentioned.