Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Since February 11,1986 to February 25,1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Some details lacking, but study performed in GLP, following official guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: EC Directive 84/449 (Official Journal of the European Communities 27, 1984, L 251, 96).
Deviations:
no
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:Winkelmann
- Age at study initiation: males 9 weeks , females 14 weeks
- Weight at study initiation: males 155-170, females 171-178 g.
- Housing:The rats were conventionally housed in cages Makrolon type III with chip wood pellets , 5 rats for each cage
- Fasting period before study:no, the was wasn't available approximately 16 hours before until 4 hours after application
- Diet: Altromin R 1324 ad libitum
- Water : tap water ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C):22 ± 2 ° C
- Humidity (%): 50 ± 10%
- Photoperiod : 12 hours cycle dark/light from 6 AM to 18 CET PM

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle:20 ml / kg
Doses:
5000 mg/kg
No. of animals per sex per dose:
5 animals x sex x single dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:twice a day
- Necropsy of survivors performed:yes with diethyl ether
- Other examinations performed: clinical signs,

Upon application and at the end of the 14-day observation period the surviving animals were weighed individually.

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD0
Effect level:
ca. 5 000 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 3 600 mg/kg bw
Based on:
act. ingr.
Mortality:
no mortality observed
Clinical signs:
no signs observed
Body weight:
no data
Gross pathology:
no pathology observed

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 for Direct Brown 44 is greater then 5000 mg/kg bw (LD50 > 3600 mg/kg bw based on active ingredient). No signs of toxicity was observed
Executive summary:

Direct Brown 44 was tested for acute toxicity with oral administration on male and female Wistar rats. The LD50 for male and female rats was greater than 5000 mg / kg body weight. There were no signs of toxicity.