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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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

Constituent 1
Chemical structure
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.