Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
12 Jun - 27 Sep 1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given (no data on test substance purity, only 2 animals per sex/dose).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
(no data on test substance purity, only 2 animals per sex/dose)
GLP compliance:
not specified
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): Only trade name given
- Substance type: organic
- Physical state: yellow clear liquid, water insoluble
- Analytical purity: no data

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 198 g (males), 163 g (females)
- Fasting period before study: 15 h

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
peanut oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: no data
Doses:
5,000 mg/kg bw
No. of animals per sex per dose:
2
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 24 h, 7 days and 14 days
- 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:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occured during the study period.
Clinical signs:
During the 14 day observation period, no symptoms of acute intoxication were observed at all.
Body weight:
No effect on body weight was noted (see table 1).
Gross pathology:
14 days after the treatment, the inner organs of all the animals were without any pathological findings.

Any other information on results incl. tables

Table 1: Average body weights of the 2 male and the 2 female rats in g.

sex

before application

24 h

7 days

14 days

after treatment

male

198

202

232

255

female

163

164

176

181

 

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified