Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
14.11.1988-28.11.1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
yellow to brown granulate, technical grade

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
Animals were kept in groups of 5 in Makrolon cages at 22 ±3 °C and 50 ±20% relative humidity with 12 hours ilumination per day. The acclimatisation period prior to dosing was minimum 5 days. 16 hours before application and 3 - 4 hours thereafter no feed was provided. Water was orvided ad libitum. Animals were individually marked with KMnO4 marks on fur and cages were clearly identifiable.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: sesame oil
Doses:
2000 mg/kg
concentration: 20%(w/v)
application volume: 10 ml/kg bw
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality after 14 days observation
Clinical signs:
Obserced symtoms 4 - 6 h after application: crouch position, drawn-in flanks, irregular breathing (only male), reduced activity, uncoordinated movement (only female). After one day no symptoms were observed.
Body weight:
normal development
Gross pathology:
without finding
Other findings:
no other findings

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 in this study was >2000 mg/kg bw; no mortality was observed.
Executive summary:

The study on acute oral toxicity of Additol XL 465 (Hoechst name of EC 258-981-8 N,N'-(methylenedi-p-phenylene)bis[hexahydro-2-oxo-1H-azepine-1-carboxamide]) on male and female Wistar-rats results in a LD50 of >2000 mg/kg bw. After application of 2000 mg/kg bw no mortality was observed but slight symptoms.

At the day of application the animals showed symptoms crouch position, drawn-in flanks, irregular breathing (only male), reduced activity, uncoordinated movement (only female). From second day there were no symptoms observed.

No pathologic finding was observed.

The development of body weight was normal.

The result of the study is sufficient for classification.