Registration Dossier
Registration Dossier
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EC number: 224-709-1 | CAS number: 4457-71-0
Acute Toxicity: other routes
Administrative data
- Endpoint:
- acute toxicity: other routes
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well-documented study that meets basic sicentific principles
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
- Principles of method if other than guideline:
- 5 mice per sex per group were intraperitoneally administered different doses of the test substance.
- GLP compliance:
- no
Test material
- Reference substance name:
- 3-methylpentane-1,5-diol
- EC Number:
- 224-709-1
- EC Name:
- 3-methylpentane-1,5-diol
- Cas Number:
- 4457-71-0
- Molecular formula:
- C6H14O2
- IUPAC Name:
- 3-methylpentane-1,5-diol
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ivanovas
- Weight at study initiation: 21.0 g (males); 20.7 g (females)
- Diet: Altromin R 1324 (Altroin GmbH, Lage, Germany)
no additional details reported
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- CMC (carboxymethyl cellulose)
- Doses:
- approx. 4515, 3075, 2540, 2092, 1430 and 973 mg/kg bw (calculated from 4640, 3160, 2610, 2150, 1470 and 1000 µL/kg bw, assuming test substance density of 0.973 g/mL)
- 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: the day of treatment, and daily thereafter
- Frequency of weighing: day 3, 7 and 13
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 150 - < 2 610 other: µL/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 092 - < 2 540 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: [Dose calculated with density = 0.973 g/mL]. All mice died treated with 2540 mg/kg bw. One mouse died treated with 2092 mg/kg bw.
- Mortality:
- - 2540 mg/kg bw: 10/10
- 2092 mg/kg bw: 1/10 - Clinical signs:
- dyspnoea, apathy, abdominal position, staggering, atonia, lost pain and corneal reflex, narcotic-like condition, tremor, spastic gait, cyanosis, exsiccosis, poor general condition
- Body weight:
- - 2092 mg/kg bw: (day 3) 26.3 g (males), 23.4 g (females); (day 7) 30.4 g (males), 24.3 g (females); (day 13) 33.7 g (males), 25.6 g (females)
- 1430 mg/kg bw: (day 3) 28.6 g (males), 25.8 g (females); (day 7) 31.4 g (males), 27.0 g (females); (day 13) 33.2 g (males), 25.4 g (females)
- 973 mg/kg bw: (day 3) 23.2 g (males), 24.6 g (females); (day 7) 27.0 g (males), 26.2 g (females); (day 13) 31.4 g (males), 25.4 g (females) - Gross pathology:
- no precipitations found
Any other information on results incl. tables
Table 1: Acute i.p. toxicity: Mortality
Dose |
Conc. |
Sex |
Time of death |
||||
µL/kg |
% |
1 h |
24 h |
48 h |
7 d |
14 d |
|
4640 |
46.4 |
M |
2/5 |
5/5 |
5/5 |
5/5 |
5/5 |
F |
2/5 |
5/5 |
5/5 |
5/5 |
5/5 |
||
3160 |
31.6 |
M |
0/5 |
5/5 |
5/5 |
5/5 |
5/5 |
F |
0/5 |
5/5 |
5/5 |
5/5 |
5/5 |
||
2610 |
26.1 |
M |
0/5 |
5/5 |
5/5 |
5/5 |
5/5 |
F |
0/5 |
5/5 |
5/5 |
5/5 |
5/5 |
||
2150 |
21.5 |
M |
0/5 |
1/5 |
1/5 |
1/5 |
1/5 |
F |
0/5 |
0/5 |
0/5 |
0/5 |
0/5 |
||
1470 |
14.7 |
M |
0/5 |
0/5 |
0/5 |
0/5 |
0/5 |
F |
0/5 |
0/5 |
0/5 |
0/5 |
0/5 |
||
1000 |
10 |
M |
0/5 |
0/5 |
0/5 |
0/5 |
0/5 |
F |
0/5 |
0/5 |
0/5 |
0/5 |
0/5 |
||
Applicant's summary and conclusion
- Conclusions:
- LD50 for male and female >2092 - <2540 mg/kg bw (calculated with density = 0.973 g/mL)
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