Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
standard quality material

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
other: syringe & plastic catheter
Vehicle:
corn oil
Doses:
10ml/kilo body weight of a 50% solution of the test substance in corn oil
No. of animals per sex per dose:
5
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
discriminating dose
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
pilo-erection within 5 minutes of dosing which remainder for Day 1 but recovery completed by Day 2
Body weight:
A slightly low body weight gain was recorded for one male rat on Days 8 and 15. All other rats achieved anticipated bodyweight gains throughout the study
Other findings:
Macroscopic examination ; No macroscopic abnormalities were observed for animals killed on Day 15.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Substance Ec No 415-890-1 does not require labelling with the risk phrase "harmful if swallowed", in accordance with EC Dir 79/831/EEC Annex VI Part II(D) as described in Commission Directive 91/325/EEC
Executive summary:

The substance is considered to be of low toxic hazard