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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:
1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Standard Guideline study according to GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
Hydrogen [1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)][1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) , compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1)
EC Number:
276-857-1
EC Name:
Hydrogen [1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)][1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) , compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1)
Cas Number:
72812-34-1
Molecular formula:
C32H18CrN6O8.C11H25NO.H
IUPAC Name:
Chromate(1-), [1-[2-[2-(hydroxy-kO)-4-nitrophenyl]diazenyl-kN1]-2-naphthalenolato(2-)-kO][1-[2-[2-(hydroxy-kO)-5-nitrophenyl]diazenyl-kN1]-2-naphthalenolato(2-)-kO]-, hydrogen, compd. with 3-[(2-ethylhexyl)oxy]-1-propanamine (1:1:1)
Constituent 2
Reference substance name:
SAVINYL BLACK RLSN
IUPAC Name:
SAVINYL BLACK RLSN
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: BRL Ltd., Basel, Switzerland
- Age at study initiation: 8 weeks
- Weight at study initiation: m: 187-211; f: 157-176
- Fasting period before study: over night
- Housing: Group housing of 5 animals per sex per cage in labelled polycarbonate cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

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

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
VEHICLE
- Concentration: 1% in water
- Amount of vehicle (if gavage): 10 mL/kg
Doses:
2000 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: observations: daily; weighing: weekly
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD0
Effect level:
2 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
other: Clinical signs noted were dark faeces, observed in all animals on day 2, 3 and 4, and. blue discolouration of the skin, observed in all animals between days 2 and 12. Alopecia noted in one female was considered not related to treatment and not toxicologic
Gross pathology:
No findings
Other findings:
none

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The oral LD50 value of the test item in rats was established as exceeding 2000 mg/kg body weight for both sexes.
Executive summary:

Assessment of acute oral toxicity with the test item in the rat.

The study was carried out in accordance with DECO Guideline No. 401, "Acute Oral Toxicity" and EEC Directive 92/69/EEC, Part B.1, "Acute Toxicity-Oral".

The test item was administered by oral gavage to five 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 at the end of the experimental period.

No mortality occurred during the study period. Treatment related clinical signs observed during the study were dark faeces (days 2-4) and blue discolouration of the skin (between days 2 and 12). The body weight gain over the study period shown by the animals was considered to be similar to that expected of normal untreated animals of the same age and strain. Macroscopic post mortem examination of the animals at termination did not reveal any abnormalities.

The oral LD50 value of the test item in rats was established as exceeding 2000 mg/kg body weight for both sexes.