2-chloro-2-methylpropane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Principles of method if other than guideline:

Guideline is not stated in the study report. However, the method used is described in sufficient detail and follows standard acute method in principal.

GLP compliance:

no

Remarks:

study performed prior to implementation of GLP

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-chloro-2-methylpropane

EC Number:

208-066-4

EC Name:

2-chloro-2-methylpropane

Cas Number:

507-20-0

Molecular formula:

C4H9Cl

IUPAC Name:

2-chloro-2-methylpropane

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: males 100-140 g, females 95-125 g
- Fasting period before study: approx. 16 hours before study initiation
- Housing: 5 animals/cage
- Diet: ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +/- 1°C
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

2.5, 3.2, 4.0 and 5.0 ml/kg bw (equivalent to 2100, 2700, 3400 and 4200 mg/kg bw when taking into account the density of 0.84 g/cm3)

No. of animals per sex per dose:

5

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: several times after dosing (day 0) and once daily thereafter
- Frequency of weighing: day 0 (prior to dosing), day 7 and day 14
- Necropsy of survivors performed: yes
- Other examinations performed: gross examination of organs at necropsy

Statistics:

Calculation of LD50 according to C.S. Weil (Biometrics, 8, 249, 1952)

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

3.5 mL/kg bw

Based on:

test mat.

95% CL:

>= 3.2 - <= 3.9

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 900 mg/kg bw

Based on:

test mat.

95% CL:

>= 2 700 - <= 3 300

Mortality:

Since there was no statistically significant sex-related difference in mortality across doses, the LD50 was calculated on the combined mortality
incidence data.

Clinical signs:

other: Following the application the majority of animals showed pilo-erection and ventral position. In addition: - 1/5 males animals at 2.5 mL/kg bw showed convulsions; - 1/5 males and 2/5 females at 2.5 mL/kg bw , 5/5 males and 3/5 females at 3.2 mL/kg bw, 1/5

Gross pathology:

In the animals deceased prior to termination of the study pronounced hyperemia of liver and a moderate hyperemia of stomach mucosa were observed. No changes at necropsy were observed in animals surviving the observation period of 14 days.

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Remarks:

Migrated information

Conclusions:

In this acute oral toxicity study in the rat a combined LD50 value of 3.5 ml/kg bw, equivalent to 2900 mg/kg bw, was derived.