2-methyl-4-phenyl-1,3-dioxolane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

15 Nov - 01 Dec 1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

adopted 22 Mar 1996

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Version / remarks:

1996

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

THE DEPARTMENT OF HEALTH OF THE GOVERNMENT OF THE UNITED KINGDOM

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-methyl-4-phenyl-1,3-dioxolane

EC Number:

251-752-3

EC Name:

2-methyl-4-phenyl-1,3-dioxolane

Cas Number:

33941-99-0

Molecular formula:

C10H12O2

IUPAC Name:

2-methyl-4-phenyl-1,3-dioxolane

Test animals

Species:

rat

Strain:

other: CD (Crl : CD (SD) IGS BR)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 258-270 g (males), 234-247 g (females)
- Fasting period before study: Animals were fasted overnight prior to administration and for approx. 3-4 h after dosing.
- Housing: 3 animals of the same sex per cage in solid-floor polypropylene cages, bedding woodflakes
- Diet: Rat and Mouse Expanded Diet No.1 (Special Diets Services Limited, Witham, UK), ad libitum
- Water: mains drinking water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): approx. 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 1.94 mL/kg bw

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: Animals were observed 30 min and 1, 2 and 4 hours after administration and subsequently once daily for 14 days. Individual body weights were determined prior to dosing and 7 and 14 days after administration.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: LD50 cut-off of 2500 mg/kg bw according to OECD 423

Mortality:

One female animal was found dead during the day of dosing.

Clinical signs:

other: Common signs of toxicity noted were ataxia, hunched posture, lethargy, piloerection, prostration, decreased respiratory rate and laboured respiration with incidents of ptosis, loss of righting reflex and splayed gait. One female animal and all male animal

Gross pathology:

No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008

Conclusions:

In this acute oral toxicity study in rats a LD50 > 2000 mg/kg bw was found.

Executive summary:

A group of three fasted females was treated with 2000 mg/kg bw test item. This was followed by treatment of a group of three fasted animals of the other sex at the same dose level. Only one animal (female) was found dead during the observation period, on the day of dosing. Common signs of toxicity noted were ataxia, hunched posture, lethargy, pilo-erection, prostration, decreased respiratory rate and laboured respiration with incidents of ptosis, loss of righting reflex and splayed gait. One female animal and all male animals were comatose during the day of dosing. Surviving animals recovered two or three days after dosing. The surviving animals showed expected gains in bodyweight over the study period. No abnormalities were noted at necropsy of animals that were killed at the end of the study. The acute oral median lethal dose, (LD50) of the test material, in the Sprague-Dawley CD strain rat, was estimated as being greater than 2500 mg/kg bodyweight.