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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Not applicable
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: meets generally accepted scientific standards, well-documented, and acceptable for assessment
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1997

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
Not applicable
GLP compliance:
not specified
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): P-1826 (6C29-9B) (AMP)

Test animals

Species:
rat
Strain:
not specified
Sex:
male
Details on test animals and environmental conditions:
The acute oral toxicity of P-1826 (AMP) was determined using young adult male fasted rats.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: saline
Details on oral exposure:
Five groups of 10 animals each were administered orally a single dose of P-1826 diluted in saline using equal volumes.
Doses:
2200, 2400, 2800, 3600, 4000 mg/kg (440, 480, 560, 720, 800 mg/ml)
No. of animals per sex per dose:
10 male rats/dose
Control animals:
no
Details on study design:
The acute oral toxicity of P-1826 was determined using young adult male fasted rats. Five groups of 10 animals each were administered orally a single dose of P-1826 diluted in saline using equal volumes. Animals were observed closely for four hours and daily thereafter for 14 days.
Statistics:
Not applicable

Results and discussion

Preliminary study:
Not applicable
Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD0
Effect level:
2 200 mg/kg bw
Sex:
male
Dose descriptor:
LD50
Effect level:
2 900 mg/kg bw
Remarks on result:
other: + or- 140 mg/kg
Sex:
male
Dose descriptor:
LD100
Effect level:
4 000 mg/kg bw
Mortality:
Doses exceeding 2800 mg/kg orally results in rapid absorbtion into the circulatory system resulting in gross damage to the liver, kidney, spleen, and respiratory system, followed by respiratory collapse. The compound produces irritation to the stomach and duodenum at doses of 2800 mg/kg and greater.
Clinical signs:
In life observations included: traces of blood on the nostrils, labored breathing, ataxia, and death due to respiratory collapse.
Body weight:
The mean bosy weight indicated that all surviving animals gained weight.
Gross pathology:
Necropsy findings (animals that died during the observation period): gas in stomach, inflamed and gaseous duodenum, liver and spleen dark, blood clot in heart.

Necropsy findings (survivors until a scheduled necropsy): No findings in dose levels less than 2800 mg/kg. At 2800 mg/kg, 3 were grossly normal and 3 had a small amount of gas in the stomach with a slightly inflamed duodenum. At 3600 mg/kg, 1 was grossly normal and 1 was grossly normal except a stomach adhered to the liver.
Other findings:
The following data are reported:

LD0 = 2200 mg/kg
LD50 = 2900 +/-140 mg/kg
LD100 = 4000 mg/kg

Any other information on results incl. tables

Not applicable

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance has low acute oral toxicity.
Executive summary:

The acute oral toxicity of P-1826 was determined using young adult male fasted rats. Five groups of 10 animals each were administered orally a single dose of P-1826 diluted in saline using equal volumes. Animals were observed closely for four hours and daily thereafter for 14 days. P-1826 is the code designation for 2-amino-2-methyl-l-propanol. Doses exceeding 2800 mg/kg orally results in rapid absorption into the circulatory system resulting in gross damage to the liver, kidney, spleen, and respiratory system followed by respiratory collapse. The compound produces irritation to the stomach and duodenum at doses of 2800 mg/kg and greater. The LD50 was calculated to be 2900 mg/kg bw.