1,1,3,3-tetramethylbutyl hydroperoxide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

June, 1977

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

There are only limited details in study report, but this is consistent with other reports of this type from this period. Study was done before standardized test guidelines and GLP but was conducted using a standard and documented method at a reputable facility.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

no

Remarks:

Study performed before GLP regulations

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

1,1,3,3-tetramethylbutyl hydroperoxide

EC Number:

227-369-2

EC Name:

1,1,3,3-tetramethylbutyl hydroperoxide

Cas Number:

5809-08-5

Molecular formula:

C8H18O2

IUPAC Name:

2,4,4-trimethylpentane-2-peroxol

Test material form:

other: clear, colourless liquid

Details on test material:

The test material was a clear colourless liquid, designated TMPH, chemical name: 2.4.4.-trimethylpentyl-2-hydroperoxide.

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Young adult albino rats (Wistar-derived) from the Institute's colony were used. The body weights of males varied from 194 to 373 g, those of femals from 157 to 220 g.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

propylene glycol

Details on oral exposure:

After some preliminary observations, the test material was give by gavage, as a 10% (v/v) dilution in propylen (sic) glycol.

Doses:

Single doses of 6.0, 7.2, 8.6, 10.3 or 12.4 ml per kg body weight.

No. of animals per sex per dose:

Five males and five females

Control animals:

no

Details on study design:

After treatment the rats received stock diet and tap water ad libitum. They were observed for signs of intoxication during a 14-day period, after which autopsies were carried out on the survivors. The LD50 was calculated according to the method of Weil (Biometrics 8 [1952] 249-263).

Statistics:

none

Results and discussion

Effect levels

Key result

Dose descriptor:

LD50

Effect level:

0.92 mL/kg bw

95% CL:

>= 0.87 - <= 0.96

Clinical signs:

other: Within a few hours after dosing the rats showed sluggishness and decreased activity. Thereafter, most of the rats lost consciousness. deaths occurred between 8 hours and 3 days after treatment. Thereafter, the survivors recovered gradually and looked q

Gross pathology:

Macroscopic examination of the survivors at autopsy revealed rounded edges of the livers in some of the rats. No other treatment-related gross alterations were seen.

Any other information on results incl. tables

Dose		Mortality
dilution (ml/kg)	test material (ml/kg)	number		%
		males	females
6.0	0.60	0/5	0/5	0
7.2	0.72	1/5	0/5	10
8.6	0.86	1/5	0/5	10
10.3	1.03	5/5	5/5	100
12.4	1.24	5/5	5/5	100

Applicant's summary and conclusion

Interpretation of results:

sligthly toxic

Remarks:

Migrated information Criteria used for interpretation of results: other: conclusion in report

Conclusions:

From the mortality-figures the LD50 of TMPH was calculated to be 0.92 ml per kg body weight with 0.87 and 0.96 as the 95% confidence limits. Therefore, the material can be classified as slightly toxic.

Executive summary:

The acute oral toxicity of TMPH was determined by administration of graded doses of the test material. Young adult albino rats (Wistar-derived) from the Institute's colony were used. The body weights of males varied from 194 to 373 g, those of femals from 157 to 220 g.

After some preliminary observations, the test material was given by gavage, as a 10% (v/v) dilution in propylen (sic) glycol to groups of five male and five female rats in single doses of 6.0, 7.2, 8.6, 10.3 or 12.4 ml/kg body weight.

Within a few hours after dosing the rats showed sluggishness and decreased activity. Thereafter, most of the rats lost consciousness. deaths occurred between 8 hours and 3 days after treatment. Thereafter, the survivors recovered gradually and looked quite healthy again at the end of the observation period.

Macroscopic examination of the survivors at autopsy revealed rounded edges of the livers in some of the rats. No other treatment-related gross alterations were seen.

From the mortality-figures the LD50 of TMPH was calculated to be 0.92 ml per kg body weight with 0.87 and 0.96 as the 95% confidence limits. Therefore, the material can be classified as slightly toxic.