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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:
14 Dec 1965 - 11 Jan 1966
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1966
Report Date:
1966

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
The study was conducted according to an internal BASF method which in principle is comparable to the OECD Guideline 401. A test group consisting of 5 animals/sex was treated by single gavage application with an aqueous solution of the test substance. The animals were observed for mortality and for clinical symptoms of toxicity. At the end of the observation period of 14 days, the surviving animals were sacrificed for the purpose of necropsy; animals that died during the observations period also were subjected to necropsy. The LD50 value was estimated on the basis of the observed mortalities.
GLP compliance:
no
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 1,2-Propylendiamin
- Analytical purity: 99 %

Test animals

Species:
rat
Strain:
other: US-rats
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: male: 235 - 305 g; female: 124- 206 g

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Aqua dest.
- Concentration in vehicle: 2 % and 20 %
Doses:
200, 800, 1000, 1250, 1600, 3200 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 12-14 days
- Frequency of observations: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 1 300 mg/kg bw
Mortality:
Observed; for details please refer to "Any other information on results incl. tables".
Clinical signs:
Staggering, prone and side positions, intermittent respiraton, ruffled fur.
Body weight:
no data
Gross pathology:
Animals that died: gastrorectasis and corrosion.

Sacrificed animals: no abnormalities.

Any other information on results incl. tables

Mortality:

  Dose (mg/kg bw)  conc. (%) Gender  1 h  24 h  48 h  day 7  day 14
3200 20 male 0/5 5/5 5/5 5/5 5/5
3200 20 female 0/5 5/5 5/5 5/5 5/5
1600 20 male  0/5  2/5  2/5  2/5  2/5
1600 20 female  0/5  4/5  4/5  4/5  4/5
1250 20 male  0/5  0/5  0/5  0/5  0/5
1250 20 female  0/5  3/5  3/5  3/5  3/5
1000 20  male  0/5  0/5  0/5  0/5  0/5
1000 20 female 0/5  1/5  1/5  1/5  1/5
800 20 male  0/5  0/5  0/5  0/5  0/5
800 20 female 0/5  1/5  1/5  1/5  1/5
200 2  male  0/5 0/5  0/5 0/5 0/5
200 2  female  0/5  0/5  0/5  0/5  0/5

The application of the test substance caused toxicity (including mortality) in a dose dependent matter.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
The LD50 for oral acute toxicity in rats was calculated as 1.5 ml/kg bw which corresponds to ca. 1300 mg/kg bw based on the density 0.86 g/cm3 .
Executive summary:

In a study which was in large parts equivalent to methods described in OECD guideline 401, doses of 200, 800, 1000, 1250, 1600, 3200 mg/kg bw of an aqueous solution of the test substance were applied by gavage to male and female US-rats (5 animals per sex per dose). The animals were observed for mortality and for clinical symptoms of toxicity. At the end of the observation period of 14 days, the surviving animals were sacrificed for the purpose of necropsy; animals that died during the observation period also were subjected to necropsy. Mortality occurred at doses of 800 mg/kg bw and higher. At 3200 mg/kg bw all animals died within 24 h. The main clinical signs were staggering, prone and side positions, intermittent respiration and ruffled fur. At necropsy, gastrorectasis and corrosion effects were observed in animals that died during the observation period.