Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report Date:
2015

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Principles of method if other than guideline:
A study on the acute inhalation toxicity of Macrolex Rot E2G (CAS no 6829-22-7) on rats has been conducted in accordance with OECD TG#403 (2009). One group of rats was nose-only exposed to the solid aerosol of the test item at the actual concentration of 1817 mg/m³ (maximum attainable concentration). Rats exposed to air only under otherwise identical circumstances served as control animals.
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
aerosol dispenser: not specified
Remarks:
migrated information: aerosol
Details on test material:
Test item: Macrolex Rot E2G
Chemical name: 14H-Benz[4,5]isoquino[2, 1-a]perimidin-14-one
CAS name: 14H-Benz[4,5]isoquino[2, 1-a]perimidin-14-one
CAS number: 6829-22-7
Empirical formula: C22H12N2O
Molecular mass: 320.3 g/mol
Purity: 98.9%
Stability: Stability certified for the duration of study (see Appendix)
Storage conditions: room temperature
Appearance: solid, red powder
Structural formula:

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
nose only
Vehicle:
air
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
Actual concentration of 1817 mg/m³
No. of animals per sex per dose:
Three male and three female rats per concentration were simultaneously exposed under nose-only conditions for 4 h.
Control animals:
yes

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
discriminating conc.
Effect level:
1 817 mg/L air (analytical)
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: Mortality did not occur at the technically maximum attainable concentration of 1817 mg/m³.
Mortality:
Mortality did not occur at the technically maximum attainable concentration of 1817 mg/m³.
Clinical signs:
Rats exposed to the test item showed clinical signs (labored breathing, irregular breathing, piloerection).
Body weight:
Significant changes in incremental body weight gain were found in females on day 1.
Gross pathology:
Necropsy revealed light colored areas and/or few gray areas in the lungs of male and female rats on day 14.

Any other information on results incl. tables

Mortality did not occur at the technically maximum attainable concentration of 1817 mg/m³. Rats exposed to the test item showed clinical signs (labored breathing, irregular breathing, piloerection). Significant changes in incremental body weight gain were found in females on day 1. Neither reduction in body temperature nor changes during the reflex measurement were observed. Necropsy revealed light colored areas and/or few gray areas in the lungs of male and female rats on day 14.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
No mortality occurs at the technically maximum attainable concentration of 1817 mg/m³.
Executive summary:

A study on the acute inhalation toxicity of Macrolex Rot E2G (CAS no 6829-22-7) on rats has been conducted in accordance with OECD TG#403 (2009). One group of rats was nose-only exposed to the solid aerosol of the test item at the actual concentration of 1817 mg/m³ (maximum attainable concentration). Rats exposed to air only under otherwise identical circumstances served as control animals.

Mortality did not occur at the technically maximum attainable concentration of 1817 mg/m³. Rats exposed to the test item showed clinical signs (labored breathing, irregular breathing, piloerection). Significant changes in incremental body weight gain were found in females on day 1. Neither reduction in body temperature nor changes during the reflex measurement were observed. Necropsy revealed light colored areas and/or few gray areas in the lungs of male and female rats on day 14.

In summary, there is evidence of low acute inhalation toxicity in rats after exposure (4h) of aerosolized Macrolex Rot E2G (CAS no. 6829-22-7). The LC50 is > 1817 mg/m³.