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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Principles of method if other than guideline:
Acute oral toxicity in by gavage in rats.

GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Acid Orange 116
IUPAC Name:
Acid Orange 116
Test material form:
solid: particulate/powder

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 9 - 14 weeks
- Weight at study initiation: average initial weight 173 g
- Housing: groups of 5
- Diet: ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 1.5 °C
- Humidity: 60 ± 5 %
- Photoperiod: 12 h light/dark rhytm

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
- Amount of vehicle (if gavage): 30 ml/kg bw

No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
On the day of application, animals were inspected twice, over the following 14-day observation period twice a day (once on weekends and holidays), and type, onset, duration and intensity of clinical symptoms were recorded and any dead animals removed.
At application and at the end of the 14-day observation period, surviving animals were individually weighed.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD0
Effect level:
5 000 mg/kg bw
Based on:
test mat.
Mortality:
No
Clinical signs:
No symptoms
Body weight:
Unaffected

Applicant's summary and conclusion

Interpretation of results:
other: not classified according to the CLP Regulation (EC 1272/2008)
Conclusions:
LD0 = 5000 mg/kg in rats.
Executive summary:

Method

Acute oral toxicity in rats (5 M and 5 F) dosed at 5000 mg/kg by gavage. A 14 -days observation period followed administration.

Results

During the observation period, no deaths occurred, no symptoms were recorded, body weight gain was unaffected.

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