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EC number: 204-671-2 | CAS number: 124-02-7
Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Workplace Exposure Limit Documentation – Diallylamine
- Author:
- Hoechst Celanese Corporation
- Year:
- 1 996
- Bibliographic source:
- -
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Male rats were exposed to 0, 25, 50, 100 or 200 ppm of diallylamine vapour for seven hours/day for 50 days in order to assess cardiac and other organ system toxicity.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Specific details on test material used for the study:
- purity not provided
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- not specified
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 50 7-hour exposures
- Frequency of treatment:
- Daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 ppm
- Remarks:
- Control
- Dose / conc.:
- 25 ppm
- Remarks:
- (0.1 mg/L)
- Dose / conc.:
- 50 ppm
- Remarks:
- (0.2 mg/L)
- Dose / conc.:
- 100 ppm
- Remarks:
- (0.4 mg/L)
- Dose / conc.:
- 200 ppm
- Remarks:
- (0.8 mg/L)
- No. of animals per sex per dose:
- 15 males per dose
- Control animals:
- yes, concurrent no treatment
- Positive control:
- No.
Examinations
- Observations and examinations performed and frequency:
- DETAILED CLINICAL OBSERVATIONS: Yes (including mortality)
- Time schedule: Not specified
BODY WEIGHT: Yes
- Time schedule for examinations: Not specified
Details on other observations and examinaitions not specified. - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes (including organ weights)
HISTOPATHOLOGY: Yes
Results and discussion
Results of examinations
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- 200 ppm exposure group: 30% mortality. Time of deaths not specified.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- 200 ppm exposure group: Decreased bw gain
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- 50 ppm exposure group: Elevated heart and testis / bw ratios
100 ppm exposure group: Elevated heart / bw ratio
200 ppm exposure group: Elevated heart, liver, kidney and lung / bw ratios. - Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- microscopically, heart lesions were found in 11 of 15 rats
Effect levels
open allclose all
- Dose descriptor:
- NOEC
- Effect level:
- 25 ppm
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: absence of any effects at this dose
- Dose descriptor:
- NOAEC
- Effect level:
- >= 50 - <= 100 ppm
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: absence of cardiac lesions at these doses, but an elevated heart to bodyweight ratio (i.e approx 10% elevation compared to control)
Target system / organ toxicity
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 200 ppm
- System:
- cardiovascular
- Organ:
- heart
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Any other information on results incl. tables
Reported effects at 200 ppm: 30% mortality; elevated heart, liver, kidney and lung / w ratios; decreased bw gain; microscopically, heart lesions were found in 11 of 15 rats.
Repeated exposure of rats to diallylamine (fifty 7-hour exposures to 200 ppm) caused changes in liver and kidney weights, a reduction in growth, and mortality. Chemical pneumonia and myocarditis were also present in some rats (rats not specified).
Applicant's summary and conclusion
- Conclusions:
- Repeated inhalation exposure to diallylamine resulted in deleterious effects on heart and vascular tissue of rats.
- Executive summary:
Male rats were exposed to 0, 25, 50, 100 or 200 ppm of diallylamine vapour for seven hours/day for 50 days in order to assess cardiac and other organ system toxicity.
The No Observed Effect Level (NOEL) was considered to be 25 ppm based on the absence of any effects at this level. The No Observed Adverse Effect level (NOAEL) was considered to be in the range of 50 -100 ppm based on the absence of cardiac lesions at these levels, but there was an elevated heart to bodyweight ratio.
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