Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: test data from ELINCS-notification obtained from ECHA on 10-June-2010 (EC-no. 405-740-1 / notification-no. 91-06-0255-00); performed under GLP and according to EU-testing methods
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
; only two dose levels
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
no data

Test animals

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

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Doses:
Dose levels of 500 and 5000 mg/kg were tested.
No. of animals per sex per dose:
5 animals per sex and dose group.
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 1 000 mg/kg bw
Based on:
test mat.
Mortality:
Males:
- 500 mglkg bw; Number of animals: 5; Number of deaths: 1
- 5000 mglkg bw; Number of animals: 5; Number of deaths: 5

Females:
- 500 mglkg bw; Number of animals: 5; Number of deaths: 0
- 5000 mglkg bw; Number of animals: 5; Number of deaths: 5
Clinical signs:
Signs of toxicity related to dose levels:
- Deaths occured in all animals at 5000 mg/kg and one male at 500 mg/kg; all were within one day of dosing.
- Prior to deaths sedation was noted, other less frequent signs included convulsions.
- One survivor at 500 mglkg had subdued, hunched appearance, piloerection and soiled coat on day 1 and 2.
Body weight:
No data
Gross pathology:
Effects on organs:
- No treatment-related macroscopic findings were reported.

Any other information on results incl. tables

In this study, with only two dose levels, the LD50 was not closely defined. However, in a dose-range finding study performed for a repeated dose toxicity test, more than 50% of rats died within one day of receiving a dose of 1000 mg/kg. Thus the LD50 is 500-1000 mg/kg.

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The combined acute oral LD50 on rats was determined to be 500-1000 mg/kg.
Executive summary:

The LD50 was performed following OECD 401 using Sprague-Dawley rats; however only two dose levels were used. The LD50 was not closely defined. However, in a dose-range finding study performed for a repeated dose toxicity test, more than 50% of rats died within one day of receiving a dose of 1000 mg/kg. Thus the LD50 is 500-1000 mg/kg and the substance is classified as Harmful / Acute Tox. IV.