Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: well documented study

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:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2,4,6-Trimethylbenzoylchlorid
- Physical state: liquid
- Analytical purity: no data

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Herilan, Eggersmann KG
- Age at study initiation:
- Weight at study initiation: males: 180 - 220g, females: 170 - 180g
- Fasting period before study: 15 - 20h
- Acclimation period: no data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
olive oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 63.2%; 52.2%; 43%; 35.6%; 29.4%
- Justification for choice of vehicle:

MAXIMUM DOSE VOLUME APPLIED: 5ml/kg

Doses:
3160mg/kg
2610mg/kg
2150mg/kg
1780mg/kg
1470mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: 15, 30, 60, 120min after application, daily thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, weighing (days 2-4, 7, 13)
Statistics:
Finney, D.J., Probit analysis, Cambridge university press, 3red edition, 1971

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 300 mg/kg bw
Based on:
test mat.
95% CL:
> 2 055 - < 2 603
Mortality:
3160mg/kg: 4/5 males and 4/5 females died
2610mg/kg: all males and 4/5 females died
2150mg/kg: 3/5 males and no females died
1780mg/kg: 1 male and 1 female died
1470mg/kg: no animals died
Clinical signs:
dyspnoe, apathy, staggering gait, bad general state in all groups
piloerection in all but the lowest group
spastic gait in the three highest dosages
abnormal position in the two highest dosages
agitation in the highest dose
trembling in the second highest dose
Body weight:
normal weight gain
Gross pathology:
dead animals:
acute dilations (heart), congestions, erosive gastritis (large areas affected), severely reddened small intestine, bloody content
animals sacrificed on day 14:
thickened forestomach; button ulcers; liver, spleen, and peritoneum grown together

Applicant's summary and conclusion

Interpretation of results:
relatively harmless
Remarks:
Migrated information
Conclusions:
The acute oral toxicity of the test substance was 2300mg/kg in rats.