Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
other information
Study period:
Jan 1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: only shortly reported non-GLP orientating study but basic data given

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
only 3 instead of 5 animals per dose group used; application volume varying (up to 40 ml/kg)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): ZK 74.804
- Batch No.: 4419050182

Test animals

Species:
rat
Strain:
Wistar
Sex:
male

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: physiol. saline + Myrj 53
Doses:
0, 0.25, 0.5, 1.0, 2.0, 3.5 and 5.0 g/kg (with an application volume of 40 ml/kg (vehicle control) and 2, 4, 8, 16, 28 or 40 ml/kg respectively)
No. of animals per sex per dose:
3
Control animals:
yes

Results and discussion

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

Any other information on results incl. tables

No mortalities occurred. Moreover, no compound-related findings were observed in body weight gain or autopsy. Main clinical findings were spastic gait and ruffled fur which were observed on the first day after application in all dose groups. From day 2 onwards all animals were without findings.

Applicant's summary and conclusion

Executive summary:

In an orientating toxicity study the single oral administration of the test substance (ZK 74.804) to male rats at doses of 0.25, 0.5, 1.0, 2.0, 3.5 and 5 g/kg was tolerated without any mortality or compound-related macroscopic pathological signs. Main clinical findings were spastic gait and ruffled fur which were observed on the first day after application in all dose groups. From day 2 onwards all animals were without findings.

The acute oral toxicity of AD-Cyanhydrin in rats is therefore above 5 g/kg body weight.