Registration Dossier

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
other information
Study period:
1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Required data are given in the study report. Restriction: study was performed prior to the implementation of GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Principles of method if other than guideline:
BASF test, study was performed before the implementation of OECD Guidelines.
GLP compliance:
no
Remarks:
test predated GLP
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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:
mouse
Strain:
NMRI
Sex:
male/female

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
water
Details on exposure:
Concentration in vehicle (%): 0.5, 2.0, 7.0, 20.0
Application volume per dose: 10 mL/kg
Doses:
50, 200, 700, 2000 mg/kg bw
No. of animals per sex per dose:
5 per sex and dose
Control animals:
no
Details on study design:
Observation period 14 days
Statistics:
On the basis of the observed lethality, the LD50 value was determined.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 50 - < 200
Remarks on result:
other: Level of significance: 1 %

Any other information on results incl. tables

Mortality (10 animals, 5 males and 5 females):

50 mg/kg bw: 0/10

200 mg/kg bw: 10/10 (within 7 days)

700 mg/kg bw: 10/10 (within 1 day)

2000 mg/kg bw: 10/10 (within 1 h)

Clinical signs: Dyspnoea, apathy, abnormal position, reeling, atonia, tonic spasms, ruffled fur, cyanosis, paresis.

Dissection findings: No treatment-related findings were found in animals died during the study or sacrificed at the end of the observation period.

Applicant's summary and conclusion

Executive summary:

The following LD50 value has been reported after single intraperitoneal administration: Mouse, i. p. between 50 and 200 mg/kg bw. During the 14-day observation period dyspnoea and apathy were noticed in animals of all dose groups. Gross pathology revealed no treatment-related findings in all animals.