1,3-bis[12-hydroxy-octadecamide-N-methylene]-benzene

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study data over 12 years old provided by ECHA, on a previously notified substance considered comparable and suitable for read-across use for the substance being registered (see attachments for justification of read-across). Study conducted in accordance with generally accepted scientific principles, possibly with incomplete or methodological deficiencies, which do not affect the quality of relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

not specified

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

423-300-7

EC Name:

-

Cas Number:

128554-52-9

Molecular formula:

Molecular formula varies for each reaction product. See section 1.2 for the molecular formula for each identified reaction product.

IUPAC Name:

12-hydroxy-N-({3-[(12-hydroxyoctadecanamido)methyl]phenyl}methyl)octadecanamide

Constituent 2

Reference substance name:

AMIDE#71

IUPAC Name:

AMIDE#71

Test material form:

other: solid

Details on test material:

Identification: AMIDE#71
Mass median aerodynamic diameter (for liq.+ solid aerosol): 2.8 µm

Test animals

Species:

rat

Strain:

not specified

Sex:

male/female

Administration / exposure

Route of administration:

inhalation: dust

Type of inhalation exposure:

nose only

Vehicle:

air

Details on inhalation exposure:

Mass median aerodynamic diameter of test substance: 2.8 µm

Analytical verification of test atmosphere concentrations:

not specified

Duration of exposure:

4 h

Concentrations:

5.08 mg/L air

No. of animals per sex per dose:

5 males and 5 females at 5.08 mg/L

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days

Observations were made for mortality, signs of toxicity, and effects on organs at necropsy.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 5.08 mg/L air (nominal)

Based on:

test mat.

Exp. duration:

4 h

Mortality:

No mortality at 5.08 mg/L air.
Male: 5.08 mg/L; Number of animals: 5; Number of deaths: 0
Female: 5.08 mg/L; Number of animals: 5; Number of deaths: 0

Clinical signs:

other: Signs of toxicity related to dose levels: Clinical signs during exposure consisted of a slightly decreased breathing rate in all animals that developed in severity from slight in the first hour to moderate during the remainder of the exposure period. In a

Gross pathology:

Effects on organs: Abnormalities at necropsy were limited to the lungs and consisted of a few white spots on two lobes in 3 males and on one lobe in 1 female and discolouration of the lungs in two other females.

Other findings:

None.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute inhalation LC50 of the test material in the rats (male and female) was determined to be greater than 5.08 mg/L air.

Executive summary:

The test substance was assessed for acute inhalation toxicity according to OECD 403. 

No mortality occurred at 5.08 mg/L air. Dose-related signs of toxicity included a slightly decreased breathing rate in all animals that developed in severity, from slight in the first hour, to moderate during the remainder of the exposure period. In addition, slightly laboured breathing was noted in two male rats in the last two hours of exposure. Clinical signs shortly after exposure included a decreased breathing rate and sluggishness. The sluggishness continued during the first day and some rats were observed to have grunting respiration. In the remainder of the 14-day observation period no exposure-related observations were seen. At necropsy, abnormalities were limited to the lungs and consisted of a few white spots on two lobes in 3 males and on one lobe in 1 female and discolouration of the lungs in two other females.

The acute inhalation LC50 of the test material in the rats (male and female) was determined to be greater than 5.08 mg/L air.