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Diss Factsheets

Toxicological information

Repeated dose toxicity: inhalation

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Administrative data

Endpoint:
repeated dose toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Pathological report of inhalation toxicity study performed by Virginia Chem in 1984. Provides summarized histopathological results.
Remarks:
This is a narrative of the results from a 10 day exposure to ethylamine in Fischer 344 rats. Limited information provided.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
not specified
GLP compliance:
no
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethylamine
EC Number:
200-834-7
EC Name:
Ethylamine
Cas Number:
75-04-7
Molecular formula:
C2H5NH2
IUPAC Name:
ethanamine
Details on test material:
- Name of test material (as cited in study report): Ethylamine
- Analytical purity: no data

Test animals

Species:
rat
Strain:
Fischer 344
Sex:
male/female

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure:
not specified
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
10 days and 120 days
Frequency of treatment:
no data
Doses / concentrationsopen allclose all
Dose / conc.:
10 ppm (nominal)
Remarks:
120 days exposure
Dose / conc.:
100 ppm (nominal)
Remarks:
120 days exposure
Dose / conc.:
250 ppm (nominal)
Remarks:
10 days exposure
Dose / conc.:
1 000 ppm (nominal)
Remarks:
10 days exposure
Dose / conc.:
1 000 ppm (nominal)
Remarks:
120 days exposure
No. of animals per sex per dose:
10 days exposure: 5 animals
120 days exposure: 30 animals (16 males and 17 females examined at necroscopy)
Control animals:
not specified

Results and discussion

Results of examinations

Body weight and weight changes:
not specified
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
not specified
Clinical biochemistry findings:
not specified
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Immunological findings:
not specified
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
effects observed, treatment-related
Description (incidence and severity):
10 days exposure:
- Slight to moderate necrotizing inflammation of the nasal cavity in 3/5 male rats in the 250 ppm group and in 5/5 male rats in the 1000 ppm group.
- Moderate thymic atrophy after 1000 ppm expsore for all animals

120 days expsoure/ 500 ppm:
- Moderate to marked atrophic rhinitis in all animals which principally involved the anterior half of the nasal cavity and were characterized by purulent exudate in the nasal meatuses, chronic, active inflammation that was often ulcerative, necrosis and loss of the cartilagenous nasal septum, loss of boney turbinates, and squamous metaplasia of nasal epithelium
- Denudation of the mucosa occasionally resulted in exposure of conchal bone
- Resorption of facial bone was sometimes detected in areas of sever inflammation
Neuropathological findings:
not specified
Histopathological findings: non-neoplastic:
effects observed, treatment-related
Description (incidence and severity):
A short term (10-day) exposure of rats by inhalation resulted in necrotizing inflamation in the nasal cavity at 250 and 1000 ppm dose levels. Moderate to marked amounts of atrophic rhinitis occurred in rats exposed to 500 ppm for 120 days. Due to the abscence of effects after exposure to dose levels up to 100 ppm for 120 days, this is considered to be the NOAEC.
Histopathological findings: neoplastic:
not specified

Effect levels

Dose descriptor:
NOAEC
Effect level:
100 ppm
Based on:
test mat.
Sex:
male/female
Basis for effect level:
histopathology: non-neoplastic

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
A NOAEC of 100 ppm was derived for the test item after repeated inhalative expsoure of rats for 120 days.
Executive summary:

Repeated inhalative exposures of Fischer 344 rats to the test item were performed for various doses and time points. A short term (10-day) exposure of rats by inhalation resulted in necrotizing inflamation in the nasal cavity at 250 and 1000 ppm dose levels. Moderate to marked amounts of atrophic rhinitis occurred in rats exposed to 500 ppm for 120 days. Due to the abscence of effects after exposure to dose levels up to 100 ppm for 120 days, this is considered to be the NOAEC.