4-methylpent-1-ene

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Test start: 22 June 2004. Test completed: 14 December 2005

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study performed according to GLP and guideline

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

4-methylpent-1-ene

EC Number:

211-720-1

EC Name:

4-methylpent-1-ene

Cas Number:

691-37-2

Molecular formula:

C6H12

IUPAC Name:

4-methylpent-1-ene

Details on test material:

- Name of test material (as cited in study report): 4-methyl-1-pentene
- Analytical purity: 98.36%
- Lot/batch No.: 3B24A

Test animals

Species:

rat

Strain:

Crj: CD(SD)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories Japan Inc. (Atsugi Breeding Center)
- Age at study initiation: 8 female rats at 7 weeks of age for groups 1 and 2, and 8 female rats at 6 weeks of age for groups 3 and 4
- Weight at study initiation: 223-240 g
- Fasting period before study: The animals were fasted overnight (17-18 hours)
- Housing: The animals were housed in bracket-type mesh-floored metal cages (260W x 380D x 180H mm), two animals per cage during the quarantine and acclimation period, and individually after grouping
- Diet: The animals had free access to γ radiation-sterilized pellet diet CRF-1, Oriental Yeast Co., Ltd., in metal feeders
- Water: The animals had free access to Sapporo City tap water from an automatic water supply system
- Acclimation period: After receipt the animals were quarantined and acclimated: animals in group 1 until day 13 of acclimation, in group 2 until day 16 of acclimation, in group 3 until day 20 of acclimation and in group 4 until day 23 of acclimation

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3°C (actual range: 19-24°C)
- Humidity: 50 ± 20% (actual range: 45-75%
- Air changes: 10-15 times/hour
- Photoperiod: lighting for 12 hours (artificial light, 8:00-20:00)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: Group 1: 60 mg/L Group 2: 60 mg/L Group 3: 400 mg/L Group 4: 400 mg/L
- Justification for choice of vehicle: Since 4-methyl-1-pentene is insoluble in water, corn oil was selected as the vehicle in this study
- Lot No: V2T2225, Nacalai Tesque, Inc

DOSAGE PREPARATION: Refer to material and methods

CLASS METHOD:
- Rationale for the selection of the starting dose: Because there was no information of the toxicity of the test substance, the dose level in group 1 was set at 300 mg/kg in this study The next dose level was determined based on the mortality up to day 3 after administration. Because no deaths occurred in groups 1 or 2, the dose level in group 3 was set at 2000 mg/kg. Because no deaths occurred in group 3 either, the dose level in group 4 was also set at 2000 mg/kg.

Doses:

Group 1: 300 mg/kg
Group 2: 300 mg/kg
Group 3: 2000 mg/kg
Group 4: 2000 mg/kg

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: All animals were observed for mortality, appearance, behavior, etc. on the day of administration (day 0) continuously from immediately to 1 hour after administration, and then at 2 and 4 hours after administration. Animals were observed twice a day, in the morning and afternoon, from day 1 to day 13 after administration, and once in the morning on day 14 after administration
- Frequency of observations and weighing: All animals were weighed on days 0 (before dosing on the day of administration), 1, 3, 5, 7, 10 and 14 after administration
- Necropsy of survivors performed: After observation of external appearance on day 14 after administration, all animals were euthanized by ether anesthesia, and organs/tissues of the entire body were examined macroscopically

Statistics:

Mean values and standard deviations were calculated for body weight, body weight gain and the rate of increase

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No deaths occurred during the 14 days after administration either in the two 300 mg/kg groups (6 animals) or in the two 2000 mg/kg groups (6 animals). Mortality data is presented in Table 1.

Clinical signs:

other: No signs of toxicity were observed during the 14 days after administration either in the two 300 mg/kg groups (6 animals) or in the two 2000 mg/kg groups (6 animals) Results on clinical observation are shown in Table 2.

Gross pathology:

No abnormal findings were observed in in any animal either in the two 300 mg/kg groups (6 animals) or in the two 2000 mg/kg groups (6 animals). Necropsy findings are shown in Table 4.

Any other information on results incl. tables

Table 1: Mortality of female rats in acute oral toxicity test of 4-methyl-1-pentene

Group	Number of dead animals						Mortality
	Hours after administration					Days after administration
	0	0.5	1	2	4	1-14
4-Methyl-1-Pentene 300 mg/kg	0	0	0	0	0	0	0/6
4-Methyl-1-Pentene 2000 mg/kg	0	0	0	0	0	0	0/6

Table 2: General appearance of female rats in acute oral toxicity test of 4-methyl-1-pentene

Group findings	Hours after administration					Days after administration
	0	0.5	1	2	4	1-14
4-Methyl-1-Pentene 300 mg/kg Number of animals examined No abnormal findings	6   6	6   6	6   6	6   6	6   6	6   6
4-Methyl-1-Pentene 2000 mg/kg Number of animals examined No abnormal findings	6   6	6   6	6   6	6   6	6   6	6   6

Values are number of animals with findings

Table 3: Body weight changes of female rats in acute oral toxicity test of 4-methyl-1-pentene

Group	Number of animals	Body weight (g) on day after the administration							Body weight gain 1-14
		0	1	3	5	7	10	14	(g)	(%)
4-Methyl-1-Pentene 300 mg/kg	6	206.5 3.7	224.3 10.1	237.7 7.1	241.7 12.5	250.3 8.2	256.3 7.4	261.2 8.4	54.7 6.6	26.465 3.099
4-Methyl-1-Pentene 2000 mg/kg	6	202.5 3.8	221.5 7.8	234.2 6.0	235.5 8.4	239.2 8.8	247.8 4.4	256.8 6.9	54.3 6.9	26.853 3.613

Table 4: Gross findings of female rats in acute oral toxicity test of 4-methyl-1-pentene

Findings	4-Methyl-1-pentene (mg/kg)
	300	2000
Number of animals	6	6
No abnormal findings	6	6

Values are number of animals with findings

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral median lethal dose (LD50) of 4-methyl-1-pentene was >2000mg/kg and is therefore not classified in accordance with CLP Regulation (EC) no. 1272/2008