Registration Dossier

Administrative data

Description of key information

Oral Toxicity LD50: 300-400 mg/kg bw

Inhalation toxicity LD50: 0.75 mg/l (correspond to 750 mg/m3)

Dermal toxicity LD50 :1500 mg/kg

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS- Source: Winkelmann, Borchen, Germany- Age: 9 weeks male; 14 weeks female- Weight at study initiation: males: 166-201 g; females: 153-159 g (females)- Housing: 5 animals per macrolon cage type III- Diet (e.g. ad libitum): pellets of Altromin R 1234, ad libitum- Water (e.g. ad libitum): tap water, ad libitum- Acclimation period: at least 5 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 22 +/- 1.5- Humidity (%): 60 +/- 5- Photoperiod (hrs dark / hrs light): 12 / 12
Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 20 ml/mg of 630 mg/kg active substanceRATIONALE FOR SELECTION OF DOSES:The doses chosen in this experiment were based on preliminary data.
Doses:
100, 310, 400, 500 and 630 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days - Frequency of clinical observations: at least twice a day (weekends once a day)- Frequency of weighing: before application, after one week and after 14 days.- Necropsy of survivors performed: yes, all animals
Statistics:
Program Probit-Analyse, Fink and Hund (Arzneim Forsch 15, 1965, 624)
Preliminary study:
N.A.
Sex:
male
Dose descriptor:
LD50
Effect level:
>= 300 - <= 400 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
LD50
Effect level:
>= 300 - <= 400 mg/kg bw
Based on:
test mat.
Mortality:
All animals in the 630 mg/kg bw dose groups died after treatment. All the females in the 500 mg/kg bw dose group died within 24 hours.Three male and four males died in the 400 and 500 mg/kg dose group. One female and two females died in the 310 and 400 mg/kg dose group.
Clinical signs:
Treated animals for doses from 310 to 630 mg / kg showed reduction of the general condition and sedation.In addition, males from 400 mg / kg, in the case of female animals from 310 mg / kg onwards, occurred in the abdomen.Animals from the low dose showed no signs of toxicity.
Body weight:
No effects on the body weight were noted.
Gross pathology:
All of the experimental animals under test 100 to 500 mg/kg were without any macroscopic abnormal findings.In the deceased male and female animals doses 310 to 630 mg/kg were found stomach and duodenal arrested and looked out oedematoes.
Other findings:
N.A.
Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
In conclusion, in an acute oral toxicity study, the LD50 was determined to be 300-400 mg/kg bw for male and for female Wistar rats.
Executive summary:

In an acute oral toxicity study (OECD 401), groups of young adult Wistar rats (5/sex) were given a single oral dose of the test item in water.

The oral LD50 (males) was determined to be between 300-400 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
300 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LC50
Value:
750 mg/m³

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
1 500 mg/kg bw

Additional information

Justification for classification or non-classification

Based on the available tests, the substance showed effects for all the way of exposure.

Based on acute oral toxicity tests on BY29, the substance needs to be classied in Acute Toxicity Cat. 4.

Based on the inhalation test results on similar substance and based on the consideration about the substance which are part of the molecule, a classification for Acute Toxicity Inhalation Cat. 3 is required.
Based on dermal test results on similar substance a classification on Acute dermal Toxicity Cat. 4 is required.