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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given (only 2 animals/step exposed simultaneously).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
yes
Remarks:
(2 males and 2 females used, simultaneous exposure)
GLP compliance:
not specified
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): only trade name given
- Physical state: clear yellow liquid
- Analytical purity: 100%
- Lot/batch No.: 202
- Other information: soluble in mineral oil, dispersible in water

Note: Due to analytical test results the substance is defined as UVCB. For further details see IUCLID Chapter 1.2.

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
Mean body weight: males 296 g, females 219 g

Administration / exposure

Route of administration:
oral: gavage
Doses:
2000 mg/kg
No. of animals per sex per dose:
2 females, 2 males
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths or clinical symptoms were observed in all animals treated.
Clinical signs:
No deaths or clinical symptoms were observed in all animals treated.
Body weight:
The body weight gain was not influenced during the obervation period of 14 d.
Gross pathology:
No pathological changes were observed at gross necropsy.

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