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:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Principles of method if other than guideline:
One group of 3 male and 3 female Wistar rats was nose-only exposed to the dry powder aerosol of Gelbpigment E4GN atat an actual concentration of 5222 mg/m³ for 4 hours. The animals were observed for mortality, weight and clinical signs through day 14. A gross necropsy was performed.
GLP compliance:
yes
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Test substance: GELBPIGMENT E4GN

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:
0, 5222 mg/m³
No. of animals per sex per dose:
control group: 5 male and 5 female ratstest group: 3 male and 3 female rats
Control animals:
yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
discriminating conc.
Effect level:
5 222 mg/m³ air
Based on:
test mat.
Exp. duration:
4 h

Any other information on results incl. tables

Mortality did not occur up to the maximum technically attainable concentration of 5222 mg/m³.

Clinical observations revealed the following sings: Irregular breathing patterns, labored breathing patterns, high-legged gait, atony, piloerection, and motility reduced, hypothermia, and transiently decreased body weights. Towards the end of the first postexposure week all rats appeared to be indistinguishable from the control.

The respirability of the aerosol was adequate to achieve the objective of study, i.e. the average mass median aerodynamic diameter (MMAD) was 2.8 µm, the average geometric standard deviation (GSD) was 2.7.

Applicant's summary and conclusion

Executive summary:

A study on the acute inhalation toxicity of Gelbpigment E4GN on rats has been conducted in accordance with OECD TG#403 (2009). Test procedures were adapted so as to comply also with the EU Directive 92/69/EEC, and especially OECD GD#39 (2009). One group of 3 male and 3 female Wistar rats was nose-only exposed to the dry powder aerosol of Gelbpigment E4GN atat an actual concentration of 5222 mg/m³ for 4 hours. The animals were observed for mortality, weight and clinical signs through day 14. A gross necropsy was performed. The aerosol was generated so that it was respirable to rats. The results can be summarized as follows:

LC50(inhalation, 4h) -males&females: > 5222 mg/m³

Mortality did not occur up to the maximum technically attainable concentration of 5222 mg/m3. Clinical observations revealed the following sings: Irregular breathing patterns, labored breathing patterns, high-legged gait, atony, piloerection, and motility reduced, hypothermia, and transiently decreased body weights. Towards the end of the first postexposure week all rats appeared to be indistinguishable from the control.

In summary, the aerosolized test substance (solid aerosol) proved to have essentially no acute inhalation toxicity in rats.