Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1990-05-08 to 1990-05-29
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
Basic Yellow 21

Test animals

Species:
rat
Strain:
Wistar
Remarks:
Bor: WISW (SPF Cpb)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: male: 8 weeks, female: 10 weeks
- Weight at study initiation: average male: 177g female: 171g
- Fasting period before study: 16h before and 4h after application fasting
- Housing: Makrolon cage Type III, 5 animals per cage
- Diet (e.g. ad libitum): Altromin 1324 ad libitum
- Water (e.g. ad libitum): mains water ad libitum
- Acclimation period: at least 4 days acclimation

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2°C
- Humidity (%): 50 +/- 10%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12h/12h

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
DOSAGE PREPARATION: the test substanc was mixed in mains water at ambient temperature

VEHICLE
- Concentration in vehicle: 5, 10, 20 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: good water solubility


MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
Doses:
50, 100 and 200 mg/kg bw based on preliminary study
No. of animals per sex per dose:
5 per sex per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: day of application: multiple observations; during 14 days observation: twice per working day, once on weekend and holiday; weekly weighing
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
LD50 calculation based on "moving averages" according to Spearman and Kärber.
In case of dose levels with 0 and 100% mortality determination of geometric mean as "approximative" LD50

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
162 mg/kg bw
Based on:
test mat.
95% CL:
106 - 250
Sex:
male/female
Dose descriptor:
LD50
Effect level:
140 mg/kg bw
Based on:
act. ingr.
Mortality:
one and three rats/sex died at 100 and 200 mg/kg bw, respectively - see table below
Clinical signs:
100 and 200 mg/kg bw: bad general condition, sedation and prone position
100 mg/kg bw: piloerection in one male and one female animal
clinical signs occured 15 minutes after application and disappeared at the latest after 2 days
no clinical signs in the lowest dose of 50 mg/kg bw
Body weight:
not affected
Gross pathology:
died animals: affected stomach mucosa, fundus of the stomach and intestine reddened and tumid
survived animals: no findings

Any other information on results incl. tables

dose
[mg/kg bw]
animals treated/ animals died time of death mortality
[%]
male
50.0 0/5  -  0
100.0 1/5 2d 20
200.0 3/5 1-4h 60
female
50.0 0/5  -  0
100.0 1/5 1h 20
200.0 3/5 1-4h 60

dose
[mg/kg bw]
average body weight [g]
male
week 0 week 1 week 2
50.0 183 225 253
100.0 174 222 250
200.0 175 218 242
female
week 0 week 1 week 2
50.0 177 189 192
100.0 164 184 193
200.0 173 196 202

Applicant's summary and conclusion

Interpretation of results:
Category 3 based on GHS criteria
Conclusions:
The LD50 (oral, gavage) of the test substance for acute toxicity to male and female rats was calculated to be 162 mg/kg bw. The substance is classified as Category 3.