4-amino-m-cresol

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

calculation (if not (Q)SAR)

Adequacy of study:

weight of evidence

Study period:

From August 2017

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

accepted calculation method

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Qualifier:

no guideline required

Principles of method if other than guideline:

Based on the available in vivo oral acute study to investigate the oral LD50 , together with a toxicokinetics (ADME) study of topically applied compound, the acute inhalation toxic potential of 4-AMINO-m-CRESOL could be determined.

GLP compliance:

no

Test type:

other: Extrapolation calculation

Test material

Test material information

Constituent 1

Reference substance name:

4-amino-m-cresol

EC Number:

220-621-2

EC Name:

4-amino-m-cresol

Cas Number:

2835-99-6

Molecular formula:

C7H9NO

IUPAC Name:

4-amino-m-cresol

Test material form:

solid: particulate/powder

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

12.24 mg/L air

Based on:

test mat.

Any other information on results incl. tables

Calculations: Maximum volume of exposure in 4 hours:

0.074 L/min x 60 min x 4 hours = 17.76 L                                                

Determination of the correction factor oral vs. inhalation route:

Ratio of 105% oral : 100% inhalation = 1.0                                                 

Determination of the LC50 calc inhal.:       

(870 mg/kg bw x 0.250 kg bw / 17.76L)       × 1.0 = 12.24 mg/L                                          

Result: LC50 calc inhal. 4-AMINO-m-CRESOL = 12.24 mg/L

Conversion of LC50 calc inhal. to % (w/w):

1 L air: 1.2041 kg/m³ = 1204.1 g/m³ = 1204100 mg/m³ = 1204100/1000 L = 1201 mg/L          

1201 mg/L = 100 %

12.24 mg/L air = 1.011 % (w/w)                                                          

The concentration of 1.01% (w/w) 4-AMINO-m-CRESOL is lower than the concentration tested in the Draize test, at which concentration minimal irritation was observed.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

Based on the available acute oral toxicity and toxicokinetics data for 4-AMINO-m-CRESOL, the acute dermal, as well as acute inhalation, toxic potential for 4-AMINO-m-CRESOL could be calculated.
The calculated inhalation toxicity value for 4-AMINO-m-CRESOL (12.24 mg/l) is consistent with that of its analogue, 4-aminophenol (>3.42 mg/L). When this concentration is combined with the results of in vivo eye irritation studies, it can be concluded that 4-AMINO-m-CRESOL would not have a local effect in the lungs. Based on the LC50 , calc inhal. value, 4-AMINO-m-CRESOL should be classified as Acute Tox Cat.4; H332: “harmful if inhaled”, according to the Globally Harmonized System of Classification and Labeling (GHS).

Executive summary:

The acute oral toxicity of 4-AMINO-m-CRESOL was determined to be 870 mg/kg bw from a non-compliant study which was considered to be acceptable. Based on these data, 4-AMINO-m-CRESOL should be classified as Acute Tox Cat.4; H302: “harmful if swallowed”, according to the Globally Harmonized System of Classification and Labeling (GHS).

Based on the available acute oral toxicity and toxicokinetics data for 4-AMINO-m-CRESOL, the acute dermal, as well as acute inhalation, toxic potential for 4-AMINO-m-CRESOL could be calculated.

Calculations:

Maximum volume of exposure in 4 hours:

0.074 L/min x 60 min x 4 hours = 17.76 L                                                

Determination of the correction factor oral vs. inhalation route:

Ratio of 105% oral : 100% inhalation = 1.0                                            

Determination of the LC50 calc inhal.:       

(870 mg/kg bw x 0.250 kg bw / 17.76L)       × 1.0 = 12.24 mg/L                                       

Result: LC50 calc inhal. 4-AMINO-m-CRESOL = 12.24 mg/L

The calculated inhalation toxicity value for 4-AMINO-m-CRESOL (12.24 mg/l) is consistent with that of its analogue, 4-aminophenol (>3.42 mg/L). When this concentration is combined with the results of in vivo eye irritation studies, it can be concluded that 4-AMINO-m-CRESOL would not have a local effect in the lungs. Based on the LC50 , calc inhal. value, 4-AMINO-m-CRESOL should be classified as Acute Tox Cat.4; H332: “harmful if inhaled”, according to the Globally Harmonized System of Classification and Labeling (GHS).