1-methyl-1-phenylethyl peroxyneodecanoate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1977-09-02 to 1978-02-08

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1-methyl-1-phenylethyl peroxyneodecanoate

EC Number:

247-956-7

EC Name:

1-methyl-1-phenylethyl peroxyneodecanoate

Cas Number:

26748-47-0

Molecular formula:

C19H30O3

IUPAC Name:

1-methyl-1-phenylethyl 2-ethyl-2,5-dimethylhexaneperoxoate

Specific details on test material used for the study:

- Name: Cumyl peroxyneodecanoate (SN-1-4462-71)
- Purity: 90.2%
- Appearance: viscous yellowish liquid

Test animals

Species:

rat

Strain:

other: Charles River CD

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc., Portage, Michigan
- Weight at study initiation: 200 - 248 g
- Housing: Animals were housed by sex in groups of 5 rats per cage in hanging wire-mesh cages
- Water: ad libitum
- Diet: ad libitum; Purina Laboratory Chow (withheld during overnight period preceding oral administration)
- Temperature and humidity controlled quarters

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

Doses:

once (to male and female): 2034, 3229, 5126, 8137, 12918 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days

OBSERVATIONS
- Weighing: Initially, at 7 and 14 days
- Mortality/Viability: During first four hours after dosing, at 24 hours and daily thereafter

Statistics:

Statistical Reference
LD50 values and associated 95% confidence interval, slope of dose mortalitiy curve
References:
- Weil, C.S. 1952. Tables for Convenient Calculation of Median Effective Dose and Instruction in Their Use. Biometrics, 8: 249 - 263
- Thompson, W.R. and Weil, C.S. 1952. On the Construction of Tables for Moving Average Interpolation. Biometrics, 8: 51 - 54
- Eby, R. 1957. Statistical Tables for Dose Evaluation, Report No. 5711. Miles - Ames Research Laboratoy, Elkhart, Indiana

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

4 068 mg/kg bw

Based on:

test mat.

95% CL:

>= 3 132 - <= 5 284

Effect levels 2

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

6 458 mg/kg bw

Based on:

test mat.

95% CL:

>= 5 590 - <= 7 462

Effect levels 3

Sex:

male/female

Dose descriptor:

LD50

Effect level:

5 126 mg/kg bw

Based on:

test mat.

95% CL:

>= 4 294 - <= 6 118

Mortality:

At 8137 and 12918 mg/kg all animals died. At 5126 mg/kg 4/5 female animals were found dead and at 3229 mg/kg 1/5 female animals died. No deaths occured at a dose of 2034 mg/kg.
For individual results see Table 1 in box 'Any other information on results incl. tables'.

Clinical signs:

No data

Body weight:

A trend in decreasing body weight gain is observed in survived animals.
For individual results see Table 1 in box 'Any other information on results incl. tables'.

Gross pathology:

No data

Any other information on results incl. tables

Table 1: Mortality and LD50 Values

Exposure Conc. mg/kg

Number of Deaths

Total Mortalities

Postexposure

Hrs.

Days

0 - 4

1

2

3

4

5

6

7 - 14

M

F

M

F

M

F

M

F

M

F

M

F

M

F

M

F

Male

Female

Total

2034

0/5

0/5

0/10

3229

1

0/5

1/5

1/10

5126

2

2

0/5

4/5

4/10

8137

1

3

3

2

1

5/5

5/5

10/10

12918

5

5

5/5

5/5

10/10

The Acute Oral LD50 Values and 95% Confidence Limits

Male Rats: 6458 (5590 - 7462)

Female Rats: 4068 (3132 - 5284)

Combined Male and Female Rats: 5126 (4294 - 6118)

Slope

Male Rats: 1.66

Female Rats: 1.66

Combined Male and Female Rats: 1.66

Table 2: Body Weights obtained during 14 -day observation period

Dosage Level mg/kg	Individual Rat No.	Sex	Control Weight (grams)	7-Day Weight (grams)	14-Day Weight (grams)
2034	70485	Male	211	295	334
	70486	Male	231	272	286
	70487	Male	244	312	343
	70488	Male	248	296	323
	70498	Male	243	291	324
	70490	Female	214	248	256
	70491	Female	210	243	258
	70492	Female	208	242	273
	70493	Female	202	247	254
	70494	Female	200	224	243
3229	70354	Male	200	258	310
	70355	Male	221	245	292
	70356	Male	215	281	312
	70357	Male	201	264	324
	70358	Male	213	280	325
	70349	Female	212	234	226
	70350	Female	200	240	246
	70351	Female	214	238	260
	70352	Female	200	Died	Died
	70353	Female	216	252	241
5126	70364	Male	200	211	222
	70365	Male	201	244	308
	70366	Male	205	269	318
	70367	Male	202	225	258
	70368	Male	207	248	288
	70359	Female	200	235	216
	70360	Female	200	Died	Died
	70361	Female	201	Died	Died
	70362	Female	220	Died	Died
	70363	Female	210	Died	Died
8137	70374	Male	201	Died	Died
	70375	Male	203	Died	Died
	70376	Male	208	Died	Died
	70377	Male	205	Died	Died
	70378	Male	200	Died	Died
	70369	Female	210	Died	Died
	70370	Female	218	Died	Died
	70371	Female	220	Died	Died
	70372	Female	206	Died	Died
	70373	Female	204	Died	Died
12918	70384	Male	215	Died	Died
	70385	Male	200	Died	Died
	70386	Male	210	Died	Died
	70387	Male	200	Died	Died
	70388	Male	200	Died	Died
	70379	Female	204	Died	Died
	70380	Female	200	Died	Died
	70381	Female	210	Died	Died
	70382	Female	210	Died	Died
	70383	Female	202	Died	Died

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The presented studies finds that 1-Methyl-1-phenylethyl peroxyneodecanoate is not of acute oral toxicity and that GHS criteria are not met.

Executive summary:

In a primary acute oral toxicity study (similar to OECD 401), Charles River CD rats (5/sex/dose) were orally exposed to 2034, 3229, 5126, 8137 and 12918 mg/kg bw Cumyl peroxyneodecanoate (1-Methyl-1-phenylethyl peroxyneodecanoate, 90.2% purity), suspended in corn oil. Animals then were observed for 14 days. Due to mortality distribution, the oral LD₅₀ in rats in considered to be 6458 mg/kg bw for males, 4068 mg/kg bw for females and 5126 mg/kg bw for both sexes.