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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
13 MAR 1984 to 09 APR 1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given: comparable to guidelines/standards

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
no necroscopy performed, no data produced for the other sex (females)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2-methylpentanediamine (MPMD)
- Substance type: clear, colourless liquid
- Physical state: fluid
- Analytical purity: > 90 %
- Impurities (identity and concentrations): ca. 10 % 2-ethylbutanediamine

Test animals

Species:
rat
Strain:
other: Crl:CD rats
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Laboratories, Kingston, New York, USA
- Age at study initiation: 7 weeks
- Weight at study initiation: mean boda weight per dosimg group: 237-238 g
- Fasting period before study: no data
- Housing: single
- Diet: Purina Certified Rodent Chow #5002, ad libitum
- Water: ad libitum
- Acclimation period: 1 week

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 100, 150, 200 300 mg/ml, depending on the dose
- Amount of vehicle (if gavage): between 2.06 and 2.69 ml depending on the dose
- Purity: distilled water

MAXIMUM DOSE VOLUME APPLIED: 2.69 ml
Doses:
1000, 1300, 1700, 2000, 3000 mg/kg bw, one single application
No. of animals per sex per dose:
10 male rats
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily until signs of toxicity subsided, and then at least every other day
- Necropsy of survivors performed: no
Statistics:
The LD50 was calculated with a 95 % confidence interval.

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
1 690 mg/kg bw
Based on:
test mat.
95% CL:
1 490 - 1 930
Remarks on result:
other: details see below
Mortality:
Deaths occurred within 8 days after dosing
1000 mg/kg: 0/10
1300 mg/kg: 2/10
1700 mg/kg: 4/10
2000 mg/kg: 8/10
3000 mg/kg: 10/10
Clinical signs:
non lethal dose:
salivation, lung noise, diarrhea, stained perineum

lethal dose:
shortly after dosing, blood was observed in the urine of rats dosed at 1700 mg/kg and above; this was not seen 24 h after dosing. Predominant clinical signs included diarrhea, discharges from the eyes, nose, and mouth; lung noise and hunched posture. These and other less prominent effects are generally characteristic of animals in a moribund condition.
Body weight:
non lethal dose:
slight to severe weight loss for 1-8 days after dosing

lethal dose:
slight to severe weight loss for 1-8 days after dosing followed by recovery.
Gross pathology:
not performed

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the applied test condition the test substance has an LD50 value of 1690 mg/kg bw.
Executive summary:

In a study similar to OECD guideline 401, test substance was administered via oral gavage to 10 male CD rats per dose group (1000, 1300, 1700, 2000, 3000 mg/kg bw). The LD 50 value was calculated to be 1690 mg/kg bw. Clinical signs included salivation, lung noise, diarrhea and stained perineum.