Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1995-10-17 to 1995-10-31
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Luperox 219; Di-(3,5,5)-trimethylhexanoyl)peroxide, 99,0%
- Substance type: organic peroxide
- Physical state: colourless liquid
- Analytical purity: 99%
- Purity test date: 1995-5-18
- Lot/batch No.: 693-9503-06
- Storage condition of test material: at -20°C and protected from light

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Iffa Credo, 69210 L`Arbresle, France
- Age at study initiation: approx. 8 weeks
- Weight at study initiation: males 259 +/- 6 g, females 229 +/- 2 g
- Housing: during acclimatisation 4-7 of same sex; during treatment individually
- Diet (e.g. ad libitum): free access
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days before beginning of the study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 2°C
- Humidity (%): 30-70 %
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Remarks:
the substance was administered in its original form
Details on dermal exposure:
TEST SITE
- Area of exposure: 5 cm x 6 cm (females), 5 cm x 7 cm (males)
- % coverage: 10 %
- Type of wrap if used: hydrophilic gauze pad (Semes France)

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.3 ml/kg
- Concentration (if solution): 99 %


Duration of exposure:
24 h
Doses:
2000 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
- Frequency of observations and weighing: frequent observations during hours following administration; thereafter: at least once a day; weighing: before administration and on day 1, 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
no statistics

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD0
Effect level:
>= 2 000 mg/kg bw
Based on:
test mat.
Mortality:
no death occured during obeservation period
Clinical signs:
no clinical signs and no cutaneous reactions during study
Body weight:
body weight gain was not influenced by treatment
Gross pathology:
no apparent abnormalities
Other findings:
none

Any other information on results incl. tables

Table 1: Individual and mean body weight and weekly body weight change of treated rats (g)

Dose (mg/kg)

Volume (ml/kg)

Sex

Animals

Day 1

Body weight gain

Day 8

Body weight gain

Day 15

2000

2.3

male

1

264

42

306

71

377

 

 

 

2

258

31

289

55

344

 

 

 

3

265

51

316

76

392

 

 

 

4

257

56

313

54

367

 

 

 

5

251

50

301

53

354

 

 

 

M

259

46

305

62

367

 

 

 

SD

6

10

11

11

19

2000

2.3

female

1

229

18

247

19

266

 

 

 

2

228

2

230

17

247

 

 

 

3

232

28

260

18

278

 

 

 

4

230

12

242

30

272

 

 

 

5

227

27

254

26

280

 

 

 

M

229

17

247

22

269

 

 

 

SD

2

11

12

6

13

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the experimental conditions the dermal LD0 of the test substance bis-(3,5,5-trimethylhexanoyl)peroxide was higher than or equal to 2000 mg/kg in rats. No signs of toxicity were observed at this dose.
Executive summary:

The acute dermal toxicity of bis-(3,5,5-trimethylhexanoyl) peroxide was assessed according to OECD guideline 402. The test substance was applied in its original form to the skin of one group of ten Sprague-Dawley rats (five males and five females) at a dose of 2000 mg/kg. The test site was covered by a semi-occlusive dressing for 24 h. Clinical signs, mortality and body weight gain were checked for a period of 14 days following the single administration of the test substance. All animals were subject to necroscopy. No cutaneous reactions were observed. The behaviour and body weight was not affected by the treatment. No deaths occurred at 2000 mg/kg. No abnormalities were observed at necroscopy.