Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Full studies reports are unavailable and each study can be considered as unreliable for limited information on methodology (Klimisch 3). But despite these reliability limitations, the two studies in rats and mice, evaluated in combination, can be used for risk assessment because the LD50 values are within an acceptable range and show an only low interspecies variability. Therefore, the overall rating should be Klimisch 2 (Reliable with Restrictions).
Cross-reference
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The tests were carried out in the usual manner, using 4, 5, or 10
animals per dosage group. The route of administration was oral.
GLP compliance:
no
Test type:
other: not available
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Doses:
not available
No. of animals per sex per dose:
not available
Control animals:
not specified

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
257 mg/kg bw
Based on:
test mat.
95% CL:
>= 216 - <= 298

Any other information on results incl. tables

-

Applicant's summary and conclusion

Interpretation of results:
toxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Substance can be considered as acut toxic cat. 3 (oral route)
Executive summary:

-