2-methylpentane-1,5-diamine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

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

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

Test material information

Constituent 1

Reference substance name:

2-methylpentane-1,5-diamine

EC Number:

239-556-6

EC Name:

2-methylpentane-1,5-diamine

Cas Number:

15520-10-2

Molecular formula:

C6H16N2

IUPAC Name:

2-methylpentane-1,5-diamine

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 or test system 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:

other: other: 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

Gross pathology:

not performed

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

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.