Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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: This is a summary of a study reviewed by an authoritative body, the U.S. Environmental Protection Agency (EPA), which accepted the data as scientifically valid. No detailed data are provided.

Data source

Reference
Reference Type:
review article or handbook
Title:
Unnamed
Year:
2007
Report date:
2007

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1300 (Acute inhalation toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Reference substance name:
4-aminopyridine
IUPAC Name:
4-aminopyridine
Test material form:
not specified

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
animals are between 8 and 12 weeks of age.
Temperature 22 ± 3 oC, 30-70% humidity.
Light/dark cycle: 12/12 hours

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure:
not specified
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
4 h
Concentrations:
no data
No. of animals per sex per dose:
5
Details on study design:
MMAD particle size is 1-4 µm.
Animals were exposed for 4 hours. They were observed daily for 14 days for clinical signs, and at sacrifice they underwent a gross necropsy.

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LC50
Effect level:
0.53 mg/L air
Based on:
test mat.
Exp. duration:
4 h

Any other information on results incl. tables

The LC50 of 0.5 mg/L corresponds to GHS Category 3, according to Regulation EC No. 1272/2008, as the LC50 values is between 0.25 and 1 mg/L. It was previously reported to be in Category 2 according to the U.S. OSHA Hazard Communication Standard (0.25 ≤ LC50 ≤ 1.0 mg/L), which is no longer in effect.

Applicant's summary and conclusion

Interpretation of results:
Category 3 based on GHS criteria
Remarks:
Migrated information
Conclusions:
The LC50 of 4-aminopyridine is reported to be 0.53 mg/L after 4 hours exposure, after testing of particles 1-4 µm in diameter. This corresponds to Category 3, according to Regulation EC No. 1272/2008, as the LC50 values is between 0.25 and 1 mg/L.