Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
22 January to 05 March 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Winklemann, Borchen, Germany
- Age at study initiation: Males 6 -7 weeks, Females 8 - 9 weeks
- Weight at study initiation: Initial mean weight: Males 196 g, Females 190 g
- Fasting period before study: 16 hours prior
- Housing: Conventational conditions - Makrolon Typo-III cages, 5 to a cage
- Diet (e.g. ad libitum): Altromin 1324 pellets, ad libitum
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-2
- Humidity (%): 55 +/- 5
- Air changes (per hr): 15 - 20 per hour
- Photoperiod (hrs dark / hrs light): 12 hour light/dark (artifical light from 6am to 6pm)

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
The test substance was formulated in tap water at room temperature under stirring on a magnetic stirrer. The formulation was intragastrically applied by gavage to 3 males and 3 females per dose (2000 mg/kg only females) at a constant application volume of 10 ml/kg body weight. The test substance was formulated in the application vehicle immediately prior to treatment.
Doses:
females: 200, 500, 2000 mg/kg body weight
males: 200, 500 mg/kg body weight
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Several times on day of administration, twice daily during the observation period (once on weekends & bank holidays)
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 500 - < 2 000 mg/kg bw
Based on:
test mat.
Remarks:
ca. 100% purity
Mortality:
All females died between 2 hours and 2 days after gavage of 2000 mg/kg bw. At 200 and 500 mg/kg bw no deaths were observed in male and female rats.
Clinical signs:
After administration of 2000 mg/kg body weight the following clinical signs were observed in female rats: apathy, piloerection, poor general condition and hunched posture.
A single dose of 200 mg/kg and 500 mg/kg was tolerated by male and female rats without any clinical signs of toxicity.
Body weight:
Body weight development of male and female rats was not noticeable affected in this dosages.
Gross pathology:
Reddened mucosae of the stomach and intestine as well as reddenig of the subcutaneous fatty tissue were observed at necropsy in the intercurrent death animals. None of the animals sacrificed at the end of study showed any noticeable gross pathological findings.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
The LD50 was estimated to be between 500 and 2000 mg/kg body weight for male and female rats.
Executive summary:

Acute toxicological investigations of male and female Wistar rats were conducted after single oral administration of BASIC RED 015 FL. 200%. After administration of 2000 mg/kg body weight the following clinical signs were observed in female rats: apathy, piloerection, poor general condition and hunched posture.

A single dose of 200 mg/kg and 500 mg/kg was tolerated by male and female rats without any clinical signs of toxicity. Body weight development of male and female rats was not noticeable affected in this dosages.

All females died between 2 hours and 2 days after gavage of 2000 mg/kg bw. At 200 and 500 mg/kg bw no deaths were observed in male and female rats.

Reddened mucosae of the stomach and intestine as well as reddenig of the subcutaneous fatty tissue were observed at necropsy in the intercurrent death animals. None of the animals sacrificed at the end of study showed any noticeable gross pathological findings.

The LD50 was estimated to be between 500 and 2000 mg/kg body weight for male and female rats.