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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Jan to Apr 1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Version / remarks:
EG-Richtlinie 84/449 (Amtsblatt der Europaischen Gemeinschaften 27, 1984, L 251, 96)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
Basic Violet 16

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: males: 9 weeks; females: 14 weeks
- Weight at study initiation: males: 185 g; females: 177 g
- Fasting period before study: 16 hours prior to 4 hours after dosing
- Housing: 5 per cage
- Diet (ad libitum): Altromin 1324, ltromin GmbH, Lage, Germany
- Water (ad libitum): tap
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 40 - 60
- Air changes (per hr): -
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 14. Jan to 21. Apr 1986

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: depending on dose level: 10, 20, 30, 40, 50 mL/kg bw
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: the substance is a liquid formulation in aqueous acetic acid

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
Doses:
100, 200, 300, 400, 500 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 observations and weighing:
- clinical signs: Day 1: multiple times
Days 2 to 14: 2/day on weekends and holidays 1/day
- body weight: begin and end of study
- Necropsy of survivors performed: yes; and on all animals that died during the observation period
Statistics:
LD50 calculation; p <= 0.05 according to Rosiello et al., J. Tox. Environ. Health 3, 797, (1977)

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
326 mg/kg bw
Based on:
test mat.
95% CL:
>= 284.6 - <= 375.6
Remarks on result:
other: slope=3.21
Mortality:
mL/kg bw deaths (m/f)
100 0/0
200 0/1 within 1 hour
300 1/2 between 2 and 24 h
400 2/5 between 2 h and 9 days
500 5/5 within 2 hours
Clinical signs:
200 - 500 mg/kg bw: poor general condition, sedation to narcosis, prone/lateral position, reduced growth

no effects at 100 mg/kg bw
Body weight:
reduced gain at 300 and 400 mg/kg bw
Gross pathology:
Unscheduled deaths:
200 - 500 mg/kg: stomach mucosa: folds decreased; internal organs discoloured

Scheduled deaths: no effects

Applicant's summary and conclusion

Interpretation of results:
Category 3 based on GHS criteria
Conclusions:
The LD50 in male and female rats was 326 mg/kg bw. No clinical signs or deaths were observed at 100 mg/kg bw.