Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
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 guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
Yellow powder
Specific details on test material used for the study:
- Lot/batch No.: T05003
- Expiration date of the lot/batch: 17 June 2000
- Stability under test conditions: stable in vehicle for at least 96 h
- Storage condition of test material: at room temperature in the dark

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River, Sulzfeld, Germany.
- Age at study initiation: approx. 8 weeks old
- Weight at study initiation: average 274 g (males) and 193 g (females)
- Fasting period before study: overnight
- Housing: 3 animals per sex per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 50
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 1997-07-30 To:1997-08-15

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
propylene glycol
Details on oral exposure:
VEHICLE
- Concentration in vehicle: adjusted for body weight
- Amount of vehicle: 10 mL/kg
- Justification for choice of vehicle: pre-test and stability

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
Doses:
2000 mg/kg bw
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: Body weight days 1 (pre-administration), 8 and 15. Viability was checked twice daily.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs (at periodic intervals on the day of dosing (day 1) and once daily thereafter, until day 15)
Statistics:
Not needed.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortality observed
Mortality:
None
Clinical signs:
Hunched posture and uncoordinated movements were noted in the majority of animals. The animals had recovered from the symptoms between days 2 and 3, except for one female, which showed hunched posture up to day 4 and on day 12.
Body weight:
no effects
Gross pathology:
No findings
Other findings:
Yellow staining of the skin by the test substance was noted in all animals between days 3 and 8.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

The pigment was administered by oral gavage to three Wistar rats of each sex at 2000 mg/kg body weight. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed. Hunched posture and uncoordinated movements were noted in the majority of animals. The animals had recovered from the symptoms between days 2 and 3, except for one female, which showed hunched posture up to day 4 and on day 12. Yellow staining of the skin by the test substance was noted in all animals between day 3 and 8. Body weight gain shown by the animals over the study period was considered to be normal. No abnormalities were found in the animals at macroscopic post mortem examination.