Registration Dossier

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:
comparable to guideline study with acceptable restrictions
Remarks:
observation period only 7 days

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
In principle, the methods described in OECD Guideline 401 were used. Several groups of 5 and 10 rats per dose respectively were treated by gavage with preparations of the test substance in aqueous solutions with traganth. 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.
GLP compliance:
no
Test type:
standard acute method
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:
rat
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: own breeding
- Weight at study initiation: males: 112 - 274 g; females 108 - 200 g

ENVIRONMENTAL CONDITIONS
not reported

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: aqueous suspension with traganth
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 2 - 30 %

MAXIMUM DOSE VOLUME APPLIED: 21.3 cm3/kg bw in the 5581 mg/cm3 treatment
Doses:
approx. 174; 558; 872; 1090; 1395; 1744; 2180; 2790; 5581 mg/kg bw (calculated with a density of ca. 0.87 g/cm3; original data: 200, 640, 1000, 1250, 1600, 2000, 2500, 3200 and 6400 µL/kg bw)
No. of animals per sex per dose:
5 per dose or 5 per sex per dose (see result table)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days (except the treatment group of 1090 mg/kg bw, 20 % concentration: 12 d)
- Frequency of observations: daily on workdays
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Statistics:
not performed

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 1 047 mg/kg bw
Based on:
test mat.
Remarks on result:
other: original data: ca 1200 µL/kg bw
Mortality:
Mortality mostly occurred within the first two days after dosing. Animals which survived recovered within day 2 to 4. For more details see table below.
Clinical signs:
Dyspnoea, convulsive chewing, spastic gait, saltatory spasms, rolling convulsions, abdominal/lateral position several hours after application.
Body weight:
not observed
Gross pathology:
Nothing abnormal found on necropsy.

Any other information on results incl. tables

Cumulated mortality:
Dose           1hr      24hrs   48hrs    7days

174 mg/kg      0/5      0/5     0/5      0/5
558 mg/kg      0/5      0/5     0/5      0/5
872 mg/kg      0/15     1/15    2/15     2/15   
1090 mg/kg     0/20     7/20    8/20     11/20     
1395 mg/kg     0/20     12/20   12/20    11/20*
1744 mg/kg     0/10     7/10    7/10     7/10
2180 mg/kg     0/10     7/10    8/10     8/10
2790 mg/kg     0/10     10/10   10/10    10/10
5581 mg/kg     0/10     10/10   10/10    10/10

*12/20 after 12 d

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria