Methoxyacetic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not applicable

Principles of method if other than guideline:

Study was performed before the implementation of OECD Guidelines, but followed in principle the test procedure described in OECD Guideline 401.

GLP compliance:

no

Remarks:

test predated GLP

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Methoxyacetic acid

EC Number:

210-894-6

EC Name:

Methoxyacetic acid

Cas Number:

625-45-6

Molecular formula:

C3H6O3

IUPAC Name:

2-methoxyacetic acid

Constituent 2

Reference substance name:

2-methoxyacetic acid

IUPAC Name:

2-methoxyacetic acid

Details on test material:

Name of test material:
Methoxyacetic acid

Impurities (identity and concentrations):
appr. 0.2 % formic acid
max. 0.5 % water
max. 0.1 % formaldehyde
< 0.1 % glycolic acid
< 0.1 % oxalic acid
< 0.5 % varied ester
< 0.001 % N

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Male rats: 180 - 200 g in weight.
Female rats: 160 - 170 g in weight.
Rats were fasted 15 - 20 hours prior to application.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

Concentration in vehicle (%): 6.81, 10.0, 14.7, 21.5, 31.6, 46.6
Application volume per dose: 10 mL/kg

Doses:

681, 1,000, 1,470, 2,150, 3,160 or 4,640 mg/kg bw

No. of animals per sex per dose:

5 rats per sex and dose

Control animals:

no

Details on study design:

Several groups of 5 rats per sex and dose were treated by gavage with preparations of the test substance in water as vehicle. The concentrations of these preparations were usually adjusted to achieve a comparable volume of 10 mL per kg bw per animal. An observation period of 14 days was chosen.
Body weight was determined before the start of the study and 2-4, 7 and 13 days after dosing, too. Clinical signs were recorded and gross pathology was performed at the end of the observation period (day 14).

Statistics:

On the basis of the observed lethality, the LD50 value was determined.

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 1 000 - < 1 470 mg/kg bw

Remarks on result:

other: Level of significance: > 1000 mg/kg bw: 10%, < 1500 mg/kg bw: 1%

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

> 1 000 - < 1 470 mg/kg bw

Remarks on result:

other: Level of significance: 5 %

Effect levels 3

Sex:

female

Dose descriptor:

LD50

Effect level:

ca. 1 000 mg/kg bw

Mortality:

681 mg/kg bw: males: 0/5; females: 0/5
1,000 mg/kg bw: males: 0/5; females: 2/5 (within 7 days)
1,470 mg/kg bw: males: 5/5 (within 2 days); females: 5/5 (within 2 days)
2,150 mg/kg bw: males: 5/5 (within 1 day); females: 5/5 (within 1 day)
3,160 mg/kg bw: males: 5/5 (within 1 day); females: 5/5 (within 1 day)
4,640 mg/kg bw: males: 5/5 (within 1 day); females: 5/5 (within 1 day)

Clinical signs:

other: Dyspnoea, abnormal position, rattling, apathy, tumbling, atonia, spastic gait, tonic spasms, ruffled fur, cyanosis, dehydration, bulging eye, gummy eyes, abducted extremities, paresis, grave general condition. No clinical signs were observed in animals t

Gross pathology:

Animals which died during the observation period:
Heart: acute dilatation, acute congestive hyperaemia
Lung: acute swelling of moderate severity,
Stomach: extensive bloody ulceration, haemorrhagic corrosive gastritis
Gut: necrosis of the mucosa, bloody contents, severe congestion of the vessels

Animals sacrificed at the end of the observation period:
Organs without findings.

Other findings:

No data.

Applicant's summary and conclusion

Interpretation of results:

harmful

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Methoxyacetic acid is considered to be harmful following acute oral exposure.

Executive summary:

In an acute oral toxicity study, groups of Sprague-Dawley rats (5/sex, males: 180 – 200 g, females: 160 – 170 g) were given a single oral dose of Methoxyacetic acid diluted in water at doses of 681, 1000, 1470, 2150, 3160 or 4640 mg/kg bw. Animals were then observed for 14 days. Clinical signs and dissection findings were registered.

Oral LD50 Males > 1000 < 1470 mg/kg bw

Oral LD50 Females = appr. 1000 mg/kg bw

Oral LD50 Combined > 1000 < 1470 mg/kg bw

Treatment related clinical signs were dyspnoea, abnormal position, rattling, apathy, tumbling, atonia, spastic gait, tonic spasms, ruffled fur,cyanosis, dehydration, bulging eye, gummy eyes, abducted extremities, paresis, grave general condition.

Animals that died during the observation period revealed following gross pathological changes: Heart: acute dilatation, acute congestive hyperaemia, lung: acute swelling of moderate severity, stomach: extensive bloody ulceration, haemorrhagic corrosive gastritis, Gut: necrosis of the mucosa, bloody contents, severe congestion of the vessels.

No macroscopic findings were observed in animals sacrificed at the end of the observation period.

This acute oral study is classified as acceptable. This study was performed prior to the implementation of GLP and OECD Guidelines, but is in compliance with the principles described in OECD Guideline 401.