Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study according to OECD guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
name: Cyanamide, (4,5-dihydroxy-2-thiazolyl)-
molecular formula: C4 H5 N3 S
molecular weight: 127.2
physical state: solid
analytical purity: 97.3 %

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, Germany
- Age at study initiation: 6 to 8 weeks
- Weight at study initiation: male animals 174 -180 g and the female animals of 169 - 187 g.
- Fasting period before study: approx. 17 hours + 1 hour
- Housing: polycarbonate cages type III
- Diet: ad libitum
- Water: e.g. ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22° + 1,5°C
- Humidity (%): 40% - 70%
- Photoperiod (hrs dark / hrs light): approx. 12-hour artificial lighting from 6 a.m. to 6 p.m.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Doses:
2000 mg/kg bw and 200 mg/kg bw.
No. of animals per sex per dose:
3 animals each. Females at 2000 mg/kg bw and 200 mg/kg bw. Males at 200 mg/kg bw.
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: several times on the day of treatment, and at least once a day thereafter. The body weights of the rats are recorded on day 1 before administration and then weekly. Additionally, all animals that died or are sacrificed are weighed.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 300 - < 500 mg/kg bw
Mortality:
All animals of the 2000 gm/kg bw dose group died.
Clinical signs:
At the dose of 200 mg/kg body weight in both sexes piloerection, decreased motility and labored breathing were observed. Females of the 200 mg/kg group and 2000 mg/kg group showed decreased reactivity, spasmodic state, increased salivation, narrowed palpebral fissure and temporary labored breathing. Additionally, in 200 mg/kg females spastic gait and in 2000 mg/kg females lateral position, tonical cramps, temporary tremor, temporary accelerated breathing and red salivation occurred.
The signs observed started within 25 minutes and lasted up to 4 days after the
administration.
Body weight:
There were no toxicological effects on body weights or on body weight development in males. In 200 mg/kg group females the body weight development was slightly retarded.
Gross pathology:
in animals that died during the observation period the following changes were detected:
liver: dark-red discoloration
glandular stomach: red discoloration
lung: slightly collapsed
kidneys: pale

No gross pathologic changes were observed in animals sacrificed at the end of the study period.

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance is to be classified as harmful according to the results of this study.
Executive summary:

A study for acute oral toxicity in male and female Wistar rats was conducted with the

test substance CIT (2-Cyanimino-1,3-thiazolidin) according to OECD Guideline 423.

A dose of 200 mg/kg body weight was tolerated by male and female rats without

mortalities.

At the dose of 200 mg/kg body weight in both sexes piloerection, decreased motility

and labored breathing were observed. Females of the 200 mg/kg and 2000 mg/kg

groups showed decreased reactivity, spasmodic state, increased salivation,

narrowed palpebral fissure and temporary labored breathing. Additionally, in 200

mg/kg females spastic gait and in 2000 mg/kg females lateral position, tonical

cramps, temporary tremor, temporary accelerated breathing and red salivation

occurred.

There were no toxicological effects on body weights or on body weight development

in males. In 200 mg/kg group females the body weight development was slightly

retarded.

The gross pathology investigations performed at the end of the post-observation

period did not afford any treatment-related findings.

According to the „Interpretation of results", for the test substance investigated a

LD50 of > 300 < 500 mg/kg b.w. was determined.