Registration Dossier

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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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.