Registration Dossier

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
significant methodological deficiencies
Remarks:
strong effect of the test substance concentration in vehicle on mortality

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1964
Report Date:
1963

Materials and methods

Principles of method if other than guideline:
BASF Test: Several groups of 5 or 10 mice per dose were treated intraperitoneally with preparations of the test substance in 2, 8, 10 and 20 % traganth, respectively. Group-wise documentation of clinical signs was performed over the 7-day study period. Body weight was determined before the start of the study only, as it was needed for determination of dose. The clinical signs and findings were reported in summary form. On the basis of the observed lethality, the LD50 value was estimated or determined using a graphical evaluation of the dose response curve on probability paper.
GLP compliance:
no
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
tert. Butylacrylate, stabilized with 0.02 % hydroquinone

Test animals

Species:
mouse
Strain:
other: "Tuebinger" mice
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: males: 24-36 g; females 18 - 28 g

ENVIRONMENTAL CONDITIONS
not reported

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
other: aqueous emulsion with traganth
Doses:
ca. 174, 348, 696, 870, 1088 and 1392 mg/kg (corresponding to 0.2, 0.4, 0.8, 1.0, 1.25 and 1.6 mL/kg, calculated with a density of 0.87 g/mL)
No. of animals per sex per dose:
5 (except the lowest and highest dose: here, in total 5 animals of both sexes were tested per dose)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations: daily on workdays
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Mortality:
All animals died in treatments with >=10% test substance concentration in vehicle (i.e. 696 - 1392 mg/kg) within 24 hrs, while no animal died in treatments with <=8% test substance concentration in vehicle (i.e. 174 - 696 mg/kg).
Clinical signs:
After the injection: strong staggering, abdominal position, jump convulsions, nodding spasms, dyspnoe, cyanosis, clonic-tonic convulsions, convulsive tremor, sunken flanks. Survivors recovered at least within 2 days.
Body weight:
not observed
Gross pathology:
nothing abnormal found

Applicant's summary and conclusion