Registration Dossier

Administrative data

Endpoint:
acute toxicity: other routes
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:
no guideline followed
Principles of method if other than guideline:
5 mice per sex and dose are injected i.p. with different doses of the test substance. Clinical signs and lethality are evaluated during a 14 day observation period and the LD50 is determined. Surviving animals are necropsied and gross changes recorded.
GLP compliance:
no

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:
mouse
Strain:
NMRI
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Herilan, H.Eggersmann KG
- Age at study initiation: no data
- Weight at study initiation: 22-28g
- Fasting period before study: 15-20h
- Acclimation period: no data

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
olive oil
Doses:
200mg/kg
700mg/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: 15min, 30min, 1h, 2h, 5h after injection, daily thereafter. Weighing performed on days 2-4, 7, 13
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 200 - < 700 mg/kg bw
Based on:
test mat.
Mortality:
all animals in the high dose died within7days, all animals in the low dose survived
Clinical signs:
Dypnoe, apathy, bad general state in both groups
tremor, jerks, spastic gait, stretching, piloerection in the high dose
Body weight:
high dose: decrease in males, slight gain in females (until death on days 2-4)
low dose: decrease until day four, recovery to initial weight until day 14
Gross pathology:
dead animals: substance deposits in the peritoneum
necropsied survivors: no findings

Applicant's summary and conclusion

Conclusions:
The LD50 in mice after i.p. injection of the test substance was found to be greater than 200mg/kg, but lower than 700mg/kg.