Bis(3,5,5-trimethylhexanoyl) peroxide

Acute Toxicity: dermal

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

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Bis(3,5,5-trimethylhexanoyl) peroxide

EC Number:

223-356-0

EC Name:

Bis(3,5,5-trimethylhexanoyl) peroxide

Cas Number:

3851-87-4

Molecular formula:

C18H34O4

IUPAC Name:

3,5,5-trimethylhexanoyl 3,5,5-trimethylhexaneperoxoate

Constituent 2

Reference substance name:

Di-(3,5,5-trimethylhexanoyl)peroxide

IUPAC Name:

Di-(3,5,5-trimethylhexanoyl)peroxide

Constituent 3

Reference substance name:

Luperox 219

IUPAC Name:

Luperox 219

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 or test system 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:

other: no clinical signs and no cutaneous reactions during study

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.