Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP conform guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
Five male and five female Wister rats (average weight at the beginning of the study 197 and 174 g, respectively ) received per gavage a single dose of 5000 mg/kg bw Macrolex Blau CA 51056. The animals were observed for mortality, weight and clinical signs through day 14. A gross necropsy was performed on animals killed after the observation period.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Macrolex Blau CA 51056 = CAS 41611-76-1

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Doses:
5000 mg/kg bw (m + f)
No. of animals per sex per dose:
5 male and five female animals per dose
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
>= 5 000 mg/kg bw
Based on:
test mat.

Any other information on results incl. tables

A dose of 5000 mg/kg bw was tolerated without symptoms.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information
Executive summary:

Five male and five female Wister rats (average weight at the beginning of the study 197 and 174 g, respectively ) received per gavage a single dose of 5000 mg/kg bw Macrolex Blau CA 51056. The animals were observed for mortality, weight and clinical signs through day 14. A gross necropsy was performed on animals killed after the observation period.

A dose of 5000 mg/kg bw was tolerated without symptoms. The LD50 is > 5000 mg/kg bw for male and female rats.