p-(dimethoxymethyl)anisole

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

p-(dimethoxymethyl)anisole

EC Number:

218-577-4

EC Name:

p-(dimethoxymethyl)anisole

Cas Number:

2186-92-7

Molecular formula:

C10H14O3

IUPAC Name:

1-(dimethoxymethyl)-4-methoxybenzene

Details on test material:

- Name of test material (as cited in study report): p-(dimethoxymethyl)anisole
(Anisacetal KW 7056469-1)
- Substance No.: 84/102

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. Thomae GmbH, D-7950 Biberach, FRG
- Weight at study initiation: mean 180 g (male), 189 g (female)
- Fasting period before study: 16 hours before administration, in this period only water was available ad libitum
- Housing: 5 per cage in STAINLESS STEEL WIRE MESH CAGES, TYPE DK-III (BECKER & CO., CASTROP-RAUXEL, FRG)
- Diet (e.g. ad libitum): KLIBA-LABORDIÄT, FA. KLINGENTALMUHLE AG, CH-4303 KAISERAUGST,SWITZERLAND; ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: at least one week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: olive oil

Details on oral exposure:

VEHICLE
- Amount of vehicle (if gavage): 5, 10 ml/kg bw
- Justification for choice of vehicle: substance sensitive to hydrolysis

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw

Doses:

1000, 2150, 3830 and 5000 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: Body weight was determined at the beginning of the study, on day 2, 7 and 13.
Recording of signs and symptoms several times on the day of administration, at least once each workday; check for moribund and dead animals twice each workday and once on holidays.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

4 250 mg/kg bw

95% CL:

3 380 - 6 020

Mortality:

1000, 2150 mg/kg bw: no mortality
3830 mg/kg bw: 1/5 male within 24 h; 2/5 males within 48 h; 3/5 females within 24 h
5000 mg/kg bw: 1/5 male within 24 h; 2/5 males within 48 h; 2/5 females within 24 h; 4/5 females within 48 h

Clinical signs:

other: 1000, 2150 mg/kg bw: no symptoms 3830, 5000 mg/kg bw: see table

Gross pathology:

see table

Any other information on results incl. tables

Number of dead animals:
Dose         No. of           Dead after
(mg/kg bw)   animals   1 h   24 h   48 h    7 d    14 d
------------------------------------------------------
5000          5M        0      1      2      2      2
              5F        0      2      4      4      4
3830          5M        0      1      2      2      2
              5F        0      3      3      3      3
2520          5M        0      0      0      0      0
              5F        0      0      0      0      0
1000          5M        0      0      0      0      0
              5F        0      0      0      0      0
------------------------------------------------------
M = male; F = female

SYMPTOMS:
Male animals:
No symptoms at 2150 and 1000 mg/kg dose level.

Dose (mg/kg)           5000     3830    
--------------------------------------
Dyspnea               15M-2D    15M-2H
Apathy                15M-1D    15M-2H 
Excitation             2D-5D 
Staggering             1H-2D    30M-2H 
Piloerection           1D-2D 
Poor general state    15M-2D    15M-2H
M= min., H= hour, D= day

Female animals:
No symptoms at 2150 and 1000 mg/kg dose level.

Dose (mg/kg)           5000     3830    
--------------------------------------
Dyspnea               15M-1D    15M-2H
Apathy                15M-1D    15M-2H 
Excitation                       2D-5D
Aggressiveness                      2D
Staggering             1H-1D    30M-2H 
Piloerection              1D     2D-6D
Poor general state    15M-1D    15M-2H/2D
M= min., H= hour, D= day

NECROPSY FINDINGS:
Animals that died (male and female):
General congestion.
Liver: single animals: grey-brown tinge.
Stomach: single animals: diffuse erythema of glandular stomach mucosa; 2  animals: bloody ulcerations.
Sacrificed animals (male and female):
Organs: no abnormalities detected.