4,4'-ethylidenediphenyl dicyanate

Acute Toxicity: oral

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-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

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

Test material information

Constituent 1

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:

other: 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 5

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.