Reaction mass of 4-methylpentane-2,2-diyl dihydroperoxide, dioxybis-4-methylpentane-2,2-diyl dihydroperoxide and methylisobutylketon

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:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1987

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-[(2-hydroperoxy-4-methylpentan-2-yl)peroxy]-4-methylpentane-2-peroxol; 4-methylpentan-2-one; 4-methylpentane-2,2-diperoxol

EC Number:

942-932-9

Cas Number:

37206-20-5

Molecular formula:

Reaction mass of C6H14O4 and C12H26O6 and C6H12O

IUPAC Name:

2-[(2-hydroperoxy-4-methylpentan-2-yl)peroxy]-4-methylpentane-2-peroxol; 4-methylpentan-2-one; 4-methylpentane-2,2-diperoxol

additive 1

Reference substance name:

Diisobutyl phthalate

EC Number:

201-553-2

EC Name:

Diisobutyl phthalate

Cas Number:

84-69-5

Molecular formula:

C16H22O4

IUPAC Name:

diisobutyl phthalate

Test material form:

liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: From the Institute´s colony
- Age at study initiation: Young adult
- Weight at study initiation: Males: 196 to 298 g, females: 87 to 150 g
- Fasting period before study: Before dosing the rats fasted overnight
- Housing: Housed in groups of five in screen-bottomed stainless steel cages, in a well-ventilated room

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 +/- 1°C

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: shellsol T

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 50 %

MAXIMUM DOSE VOLUME APPLIED: 6.22 mL/kg bw

Doses:

3.00, 3.60, 4.32, 5.18 or 6.22 mL/kg bw equivalent to 2670, 3204, 3844.8, 4610.2, 5535.8 mg/kg bw

No. of animals per sex per dose:

groups of 5 males and 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, macroscopic examinations

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 575.3 mg/kg bw

Based on:

test mat.

95% CL:

>= 1 424 - <= 1 735.5

Remarks on result:

other: Conversion of mg/kg bw based on density of 0.89

Mortality:

2670 mg/kg bw: 3/10
3204 mg/kg bw: 4/10
3844.8 mg/kg bw: 9/10
4610.2 mg/kg bw: 9/10
5535.8 mg/kg bw: 10/10

Clinical signs:

other: Within a few hours after dosing the rats showed sluggishness, sedation and ataxia. Later on coma was frequently observed.

Gross pathology:

Macroscopic examination of the survivors did not reveal any treatment-related gross alterations.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The acute oral toxicity of the test item was examined in a study equivalent to OECD guideline 401. The LD50 value was determined to be 1575.3 mg/kg bw.

Executive summary:

The acute oral toxicity of the test item was examined in a study equivalent to OECD guideline 401. The test substance was applied in doses of 3.00, 3.60, 4.32, 5.18 or 6.22 mL/kg bw equivalent to 2670, 3204, 3844.8, 4610.2, 5535.8 mg/kg bw. The test material was given by gavage as 50 % dilution in shellsol T to groups of 5 male and 5 female albino rats. The LD50 value was determined to be 1575.3 mg/kg bw. Mortality occured between 2 hours and 3 days after treatment. Animals died from 3 mL/kg bw onwards. The rats showed sluggishness, sedation and ataxia. Later on come was frequently observed. The survivors recovered gradually and looked quite healthy again at the end of the observation period.