1-methyl-1-phenylethyl peroxyneodecanoate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

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 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

only 2 animals per dose group were used

GLP compliance:

not specified

Test type:

fixed dose procedure

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
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Pennwalt Corporation (Lucidol Division), Buffalo, New York

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Sweetwater Farm, Hillsboro, Ohio
- Weight: 2343 - 3000 g
- Housing: Animals were housed individually in hanging wire-mesh cages
- Water: ad libitum
- Diet: ad libitum; Purina Rabbit Chow
- Temperature and humidity controlled quarters

Administration / exposure

Type of coverage:

occlusive

Vehicle:

not specified

Details on dermal exposure:

The hair was removed from the back of each rabbit (20 – 30% of the body surface) with an electric clipper. The test material

Duration of exposure:

24 h

Doses:

500, 1250, 3150, 7940 and 19800 mg/kg bw

No. of animals per sex per dose:

1 male and 1 female rabbits

Control animals:

no

Details on study design:

TEST SITE
- Area of exposure: Back; on 20-30% of the body surface the hair was removed.
- % coverage:
- Type of wrap if used: The area of application was wrapped with gauze bandaging and occluded with Saran Wrap.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, with tepid tap water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Dose volume: 500, 1250, 3150, 7940 and 19800 mg/kg

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 7 940 - < 19 800 mg/kg bw

Based on:

test mat.

Mortality:

The two rabbits at the 19800 mg/kg dosage level died. None of the other rabbits died during the 14-day observation period.

Clinical signs:

No data

Body weight:

Body weight gain was noted for all surviving animals during the test period, except for one male at 500 mg/kg and one female at 7940 mg/kg bw.
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: Body Weights: The following body weights were obtained during the 14-day observation period

Dosage level mg/kg	Individual rabbit no.	Sex	Control Weight (grams)	7-Day weight (grams)	14-day weight (grams)
500	30237	Male	2575	2693	2508
	30238	Female	2720	2844	2978
1250	30331	Male	2955	3038	3215
	30254	Female	3000	3226	3465
3150	30259	Male	2841	2835	3081
	30340	Female	2786	2665	2946
7940	30339	Male	2770	2668	2874
	30338	Female	2446	2251	2326
19800	30327	Male	2669	Died	Died
	30336	Female	2343	Died	Died

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In this study, the acute dermal LD50 of 1-methyl-1-phenylethyl peroxyneodecanoate (90.2% purity) was found to be greater than 7940 mg/kg but less than 19800 mg/kg.

Executive summary:

In an acute dermal toxicity study (similar to OECD 402), groups of New Zealand White rabbits (1/sex/dose) were dermally exposed to Cumyl peroxyneodecanoate (90.2% purity) in for 24 hours to 20 – 30% of the body surface at doses of 500, 1250, 3150, 7940 and 19800 mg/kg bw. Animals then were observed for 14 days. Under the conditions of this study, the acute dermal LD₅₀ of 1 -Methyl-1-phenylethyl peroxyneodecanoate was found to be greater than 7940 mg/kg but less than 19800 mg/kg.

Body weight gain was noted for all surviving animals during the test period, except for one male at 500 mg/kg and one female at 7940 mg/kg bw.

No changes in body weight gain was observed. Mortality occurred at the highest dose level (19800 mg/kg bw) in both animals. None of the other rabbits died during the 14-day observation period.