Reaction mass of 4-methylpentane-2,2-diyl dihydroperoxide, dioxybis-4-methylpentane-2,2-diyl dihydroperoxide and methylisobutylketon

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1994-07-13 to 1995-01-03

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

1987

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-[(2-hydroperoxy-4-methylpentan-2-yl)peroxy]-4-methylpentane-2-peroxol; 4-methylpentan-2-one; 4-methylpentane-2,2-diperoxol

EC Number:

942-932-9

Cas Number:

37206-20-5

Molecular formula:

Reaction mass of C6H14O4 and C12H26O6 and C6H12O

IUPAC Name:

2-[(2-hydroperoxy-4-methylpentan-2-yl)peroxy]-4-methylpentane-2-peroxol; 4-methylpentan-2-one; 4-methylpentane-2,2-diperoxol

additive 1

Reference substance name:

Diisobutyl phthalate

EC Number:

201-553-2

EC Name:

Diisobutyl phthalate

Cas Number:

84-69-5

Molecular formula:

C16H22O4

IUPAC Name:

diisobutyl phthalate

Test material form:

liquid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Iffa Crédo, 69210 L'Arbresle, France
- Age at study initiation: Approximately 8 weeks old
- Weight at study initiation: Male: 257 +/- 13 g, Female: 218 +/- 10 g
- Housing: The animals were housed in polycarbonate cages covered with a stainless steel lid.
- Diet: A04 C pelleted diet (U.A.R., 91360 Villemoisson-sur-Orge, France)
- Water: Drinking water filtered by a F.G. Millipore membrane (0.22 micron) was contained in bottles
- Acclimation period: At least 5 days before the beginning of the study

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

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: Area of skin representing 5 x 6 cm for the females and 5 x 7 cm for the males of the body surface of the animals.
- % coverage: 10 %
- Type of wrap if used: A hydrophilic gauze pad (Semes France, 54183 Heillecourt, France)

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 hours

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology

Statistics:

Evaluation of the innoxiousness or toxicity of the test substance following a single dermal application in rats should include the relationship, if any, between the animals' exposure to the test substance and the incidence and severity of all the abnormalities including behavioural and clinical abnormalities, macroscopic lesions, body weight changes, mortality and any other toxic effects.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred during the observation period.

Clinical signs:

other: No clinical signs were observed during the study. In all males, moderate erythema (grade 2) and slight or moderate oedema (grade 2 or 3) were observed from day 2 to day 4. No sign of erythema or oedema was noted after day 4. Dryness of the skin was obser

Gross pathology:

Macroscopic examination of the main organs of the animals killed at the end of the study revealed no apparent abnormalities.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute dermal toxicity of the test item was determined according to OECD guideline 402. The LD50 was determined to be >2000 mg/kg bw.

Executive summary:

The acute oral toxicity of the test item was determined according to OECD guideline 402. The test substance (50 % purity) was applied semi-occlusively to the skin of rats at a dose of 2000 mg/kg bw. 5 males and 5 females showed no mortality after an exposure period of 24 hours and an observation period of 14 days. The LD50 was determined to be > 2000 mg/kg bw. The animals were also checked for clinical signs, body weight gain and necropsy. The general behaviour of the animals was not affected by treatment. Moderate to marked cutaneous reactions were observed in both sexes the first 4 -6 days after treatment. All signs of skin irritation had subsided by day 13.

Slight decreased body weight gain was observed in both sexes the first week only. No death occured at 2000 mg/kg bw. A macroscopic examination revealed no abnormalities in the animals killed at the end of the study.