1,1-dimethoxy-2-phenylethane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

08 - 28 Oct 2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

2001

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,1-dimethoxy-2-phenylethane

EC Number:

202-945-6

EC Name:

1,1-dimethoxy-2-phenylethane

Cas Number:

101-48-4

Molecular formula:

C10H14O2

IUPAC Name:

(2,2-dimethoxyethyl)benzene

Test animals

Species:

rat

Strain:

other: Crl:CD(SD), SPF

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 8 weeks
- Weight at study initiation: 179.4 - 199.9 g
- Fasting period before study: Animals were fasted overnight, approx. 16 h prior and for approx. 4 h after dosing.
- Housing: 1 animal per cage in stainless wire mech cages (260W x 350D x 210H mm)
- Diet: Teklad Certified Irradiated Global 18% Protein Rodent Diet 2918C (Harlan Laboratories, Inc., USA), ad libitum
- Water: public tap water filtered and irradiated by ultraviolet light, ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.8 - 22.3
- Humidity (%): 48.3 - 54.1
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6

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, 4 and 6 h after dosing and thereafter once daily for 14 days. Individual body weights were recorded prior to dosing on Day 0 and on Days 1, 3, 7 and on the day of necropsy, Day 14.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50 cut-off

Effect level:

>= 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study period.

Clinical signs:

other: Abnormal gait was evident in 2 animals at 1 and 2 h after dosing. The sign disappeared 4 h after dosing.

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 according to Regulation (EC) No 1272/2008

Conclusions:

In this acute oral toxicity study in rats a LD50 cut-off value of ≥ 5000 mg/kg bw was found.

Executive summary:

The acute oral toxicity of the test substance was assessed in a study according to OECD Guideline 423 and in compliance with GLP (2015a). In a first step, a total dose of 2000 mg/kg bw of the test substance diluted in corn oil was administered to 3 female rats. Animals were observed 0.5, 1, 2, 4 and 6 hours after dosing and subsequently once daily for 14 days. Individual body weights were recorded prior to dosing on Day 0 and on Days 1, 3, 7 and on the day of necropsy, Day 14. Macroscopic examination was performed at the end of the observation period at terminal sacrifice. In a second step, 3 additional female rats were treated with 2000 mg/kg bw of the test substance diluted in corn oil. No mortalities were observed at 2000 mg/kg bw until the end of the study. Abnormal gait was evident in 2 animals at 1 and 2 hours after dosing. The sign disappeared 4 hours after dosing. All animals showed expected gains in body weight over the study period and no abnormalities were noted at necropsy. Based on the results of this study, the LD50 value was determined to be > 2000 mg/kg bw in rats. In accordance with OECD Guideline 423, Annex 2d, a cut-off value of≥5000 mg/kg bw was derived, since no mortality occurred at 2000 mg/kg bw.