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Diss Factsheets

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: comparable to OECD-guideline 401.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method

Test material

Constituent 1
Reference substance name:
609-333-1
EC Number:
609-333-1
Cas Number:
37143-54-7
Molecular formula:
C4 H11 N O
IUPAC Name:
609-333-1
Details on test material:
- Name of test material (as cited in study report): 1-methoxy-2-aminopropan

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GmbH, D-7950 Biberach, FRG
- Weight at study initiation: 180 - 200 g
- Fasting period before study: 16 h
- Housing: stainless steel wire mesh cages, Type DK-III (Becker & Co., Castrop-Rauxel, FRG)
- Diet (e.g. ad libitum): KLIBA-Labordiaet 343, Klingentalmühle, CH-4303 Kaiseraugst, Switzerland; ad libitum
- Water (e.g. ad libitum): tap water; ad libitum
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
316; 681; and 1470 mg/kg b.w.
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighting: Recording of the signs and symptoms several times on the day of administration; at least once each work day. Check for moribund and dead animals twice each workday and once on holidays. Weighting of the animals before and on days 7 and 13 after the administration.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross-pathology
Statistics:
According to Finney, D.J., Probit Analysis, cambridge University Press, 3RD ED., 1971

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 080 mg/kg bw
Remarks on result:
other: Value from interpolation
Mortality:
One female of the 681 mg/kg b.w. dose group was found dead on day 14 after application. 3 males and 5 females of the 1470 mg/kg b.w. dose group died within the first day after administration.
Clinical signs:
Clinical observation revealed dyspnea, apathy, abnormal position, staggering, atonia, paresis, piloerection, exsiccosis, salivation and poor general state in the 1470 mg/kg b.w. dose group in males and females. The two surviving males of this dose group recreated within 9 days after administration.

One female animal of the 681 mg/kg b.w. dose group showed dyspnea, apathy, piloerection and poor general state. These symptoms were only seen on days 8 and 9.
Body weight:
The expected body weight gain was observed in the course of the study.
Gross pathology:
Animals that died (male and female) in general showed congestion, reddened mucosa and bloddy contents in stomach and intestine. One animal showed empty, intensified inflated intestines and emaciation.

No pathology findings were noted from sacrificed animals (male and female).

Any other information on results incl. tables

Under the conditions of this study the median lethal dose of 1-methoxy-2-aminopropane in both, male and female rats was calculated by interpolation to be 1080 mg/kg b.w..

Applicant's summary and conclusion

Conclusions:
According to the results of this study, the substance was classified R22 (EU) and Cat. 4 (GHS).