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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
23/08/1990 to 24/10/9090
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
Toxicity study data from Hoechst Celanese corporation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: AOOECDL-001
Principles of method if other than guideline:
Acute oral toxicity study of 4-methoxyphenylacetic acid in rats.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Reference substance name:
4-Methoxyphenyl-Acetic Acid
IUPAC Name:
4-Methoxyphenyl-Acetic Acid
Constituent 2
Chemical structure
Reference substance name:
4-methoxyphenylacetic acid
EC Number:
203-166-4
EC Name:
4-methoxyphenylacetic acid
Cas Number:
104-01-8
Molecular formula:
C9H10O3
IUPAC Name:
(4-methoxyphenyl)acetic acid
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): 4-methoxyphenyl acetic acid (MPAA)
- Molecular formula (if other than submission substance): C9-H10-O3
- Molecular weight (if other than submission substance): 166.175
- Smiles notation (if other than submission substance): c1(ccc(OC)cc1)CC(O)=O
- InChl (if other than submission substance): 1S/C9H10O3/c1-12-8-4-2-7(3-5-8)6-9(10)11/h2-5H, 6H2, 1H3, (H,10,11)
- Substance type: Organic
- Physical state: Solid
- Purity-100%
Specific details on test material used for the study:
- Name of test material (as cited in study report): (4-methoxyphenyl) acetic acid
- Molecular formula:C9H10O3
- Molecular weight:166.175 g/mole
- Substance type:Organic
- Physical state:White powder or flakes, sliqht odour
- Purity-100%

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
Source: Healthy animals were obtained from SASCO Inc., Omaha, Nebraska.
- Age at study initiation: Males: Approx. 9 week of mle and 12 week of female
- Weight at study initiation: Approximately 190-350 gram at pre-fast. Animal weights fell within 20% of the group mean.
- Fasting period before study: The animals were fasted the night immediately prior to dosing.
-Housing: Animals were housed Individually, separate from other species, in Stainless Steel, wire mesh bottom cages and Each animal was assigned a unique and individual nuaber. This nuaber was peraanently indicated on the aniaal with an ear tag.
Diet (e.g. ad libitum): Fresh certified Agway rodent feed was provided ad libitum, except feed was withheld the night prior to dosing.
- Water (e.g. ad libitum): Fresh potable water was provided ad libitum.
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Within protocol limits of 77.7- 26.1 °C
- Humidity (%):Within protocol limits of 30 – 70%
- Air changes (per hr):No data
- Photoperiod (hrs dark / hrs light): 12/12 hour, light/dark cycle

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 0,2000 and 5000 mg/kg
- Amount of vehicle (if gavage): 1 ml/100 g fasted body weight
- Justification for choice of vehicle: Corn oil
- Lot/batch no. (if required): 19F0038
- Purity: No Data

MAXIMUM DOSE VOLUME APPLIED:5000mg/kg

DOSAGE PREPARATION (if unusual): Test article, homogenized in corn oil at 0,2000 and 5000 mg/kg

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: No Data
Doses:
0,2000 and 5000 mg/kg
No. of animals per sex per dose:
Total: 30
0 mg/kg bw 5 male and 5 female
2000 mg/kg bw 5 male and 5 female
5000 mg/kg bw 5 male and 5 female
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: hourly for the firlt 4 hour immediately after dosing and twice daily (am. and pm ) for the next 13 and 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: MortalityClinical signs, body weight and gross pathology were examined.
Statistics:
No details

Results and discussion

Preliminary study:
No data available
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 - < 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Effect on survival, body weights, Organ weights and gross pathology
Mortality:
When treated with 5000 mg/kg, 90% mortality was observed in treated male and female rats as compared to control.
When treated with 2000 mg/kg, 10% mortality was observed in treated male and female rats as compared to control
l.
Clinical signs:
When treated with 5000 mg/kg, oral discharge, nasal discharge, tremors, ataxia abnormal stool, lethargy, Stained coat, alopecia, hunched posture, necrosis, unthriftinees and anal discharge were observed in treated male and female rats as compared to control.
Body weight:
When treated with 5000 mg/kg, decrease in weight was observed in surviving one animal at end of the study.
When treated with 2000 mg/kg, weight gain were observed and All of the control animals also gained weight through the study period.
Gross pathology:
Liver lesions were observed in all the treated rats at 5000 mg/kg dose group.
Increased incidences of liver lesions relative to control were observed in 2000 mg/kg bw treated male and female rats considered to be treatment related.
Other findings:
No data available

Any other information on results incl. tables

MORTALITY DATA SUMMARY (DOSE: 5 G/KG)

Day

0

1

2

3

4

5

6

7

8

9

10

11

12

13

Males Alive

5

3

2

1

1

1

1

1

1

1

1

1

1

1

Males Dead

0

2

3

4

4

4

4

4

4

4

4

4

4

4

Percent Dead

0

0

60

80

80

80

80

80

80

80

80

80

80

80

Females Alive

5

3

1

0

0

0

0

0

0

0

0

0

0

0

Females Dead

0

2

4

5

5

5

5

5

5

5

5

5

5

5

Percent Dead

0

40

80

100

100

100

100

100

100

100

100

100

100

100

 

MORTALITY DATA SUMMARY (DOSE 2 G/KG) 

Day

0

1

2

3

4

5

6

7

8

9

10

11

12

13

Males Alive

5

5

5

5

5

5

5

5

5

5

5

5

5

5

Males Dead

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Percent Dead

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Females Alive

5

5

4

4

4

4

4

4

4

4

4

4

4

4

Females Dead

0

0

1

1

1

1

1

1

1

1

1

1

1

1

Percent Dead

0

0

20

20

20

20

20

20

20

20

20

20

20

20

 

MORTALITY DATA SUMMARY (VEHICLE CONTROL) 

Day

0

1

2

3

4

5

6

7

8

9

10

11

12

13

Males Alive

5

5

5

5

5

5

5

5

5

5

5

5

5

5

Males Dead

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Percent Dead

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Females Alive

5

5

5

5

5

5

5

5

5

5

5

5

5

5

Females Dead

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Percent Dead

0

0

0

0

0

0

0

0

0

0

0

0

0

0

 

Applicant's summary and conclusion

Interpretation of results:
not classified
Conclusions:
LD50 was considered to be > 2000 mg/kg bw and < 5000 mg/kg bw when rats were treated with 4-methoxyphenylacetic acid orally by gavage in corn oil.
Executive summary:

In a acute oral toxicity study, Sprague Dawley male and female rats were treated with 4-methoxyphenylacetic acid in the concentration of 0, 2000 and 5000 mg/kg orally by gavage in corn oil and observed for 14 days. 90% mortality was observed at 5000 mg/kg bw and 10% mortality at 2000 mg/kg bw in treated male and female rats as compared to control. Oral discharge, nasal discharge, tremors, ataxia abnormal stool, lethargy, Stained coat, alopecia, hunched posture, necrosis, unthriftinees and anal discharge were observed at 5000 mg/kg in treated male and female rats as compared to control. Decrease in weight was observed in surviving one animal at end of the study at 5000 mg/kg bw, weight gain were observed at 2000 mg/jkg bw and all of the control animals also gained weight through the study period. Liver lesions were observed in all the treated rats at 5000 mg/kg dose group. Increased incidences of liver lesions relative to control were observed in 2000 mg/kg bw treated male and female rats considered to be treatment related. Therefore, LD50 was considered to be > 2000 mg/kg bw and < 5000 mg/kg bw when rats were treated with 4-methoxyphenylacetic acid orally by gavage in corn oil.

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