4,4-dimethyl-3,5,8-trioxabicyclo[5.1.0]octane

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2002-02-18 to 2002-06-21

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

24 February 1987

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4,4-dimethyl-3,5,8-trioxabicyclo[5.1.0]octane

EC Number:

421-750-9

EC Name:

4,4-dimethyl-3,5,8-trioxabicyclo[5.1.0]octane

Cas Number:

57280-22-5

Molecular formula:

C7H12O3

IUPAC Name:

4,4-dimethyl-3,5,8-trioxabicyclo[5.1.0]octane

Test animals

Species:

rat

Strain:

Wistar

Remarks:

Shoe: WIST (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Tierzucht Schönwalde GmbH, Schönwalde, Germany
- Females (if applicable) nulliparous and non-pregnant: not specified
- Age at study initiation: not specified
- Weight at study initiation: males: 262-265 g; females: 198-209 g
- Housing: individually in conventional cages
- Diet (e.g. ad libitum): pell. Ssniff M-H ad libitum 24 hours per day
- Water (e.g. ad libitum): demineralized, acidified water, pH 2-3 ad libitum
- Acclimation period: at least 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23
- Humidity (%): 52-62
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

physiological saline

Details on dermal exposure:

TEST SITE
- Type of wrap if used: patches

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): dermal administration of the substance solution at a dose of 2000 mg/kg using an administration volume of 0.53 - 0.72 mL.
- Concentration (if solution): 750 mg/mL

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were performed 30 min, 1 hour, 3 hours and after > 6 hours after administration and then once daily until day 14. On day 14 a complete post mortem examination was performed. The application sites were evaluated 1, 24, 48 and 72 hours after removal of the patches. Additionally, in the three male animals the application site was also evaluated on day 6 of the study.
- Necropsy of survivors performed: yes
- Clinical signs including body weight
- Other examinations performed: clinical signs, body weight, gross pathology

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Clinical signs:

other:

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

According to the system of evaluation recommended for EU, the mean values of findings relevant for classification at the time-points 1, 24, 48 and 72 hours after administration were 0 for swelling, reddening and scab formation.

Executive summary:

In an acute dermal toxicity study according to OECD test guideline 402, groups of young adult Wistar rats (3/sex) were dermally exposed to Trioxabicyclooctan (100 % a.i) in 0.9% NaCl (750 mg/mL) for 24 hours at dose of 2000 mg/kg bw.  Animals then were observed for 14 days.

Dermal LD50 Females/Males > 2000 mg/kg bw

Trioxabicyclooctan is of low to moderate Toxicity based on LD50 values in males and females. Based on these results the test item does not need to be classified according to Regulation (EU) No. 1272/2008 (CLP).