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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report date:
1975

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
(1987)
GLP compliance:
no
Remarks:
GLP was not mandatory when study was conducted
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
N,N'-phenylene-1,4-bis[4-[(2,5-dichlorophenyl)azo]-3-hydroxynaphthalene-2-carboxamide]
EC Number:
223-460-6
EC Name:
N,N'-phenylene-1,4-bis[4-[(2,5-dichlorophenyl)azo]-3-hydroxynaphthalene-2-carboxamide]
Cas Number:
3905-19-9
Molecular formula:
C40H24Cl4N6O4
IUPAC Name:
N,N'-phenylene-1,4-bis[4-[(2,5-dichlorophenyl)azo]-3-hydroxynaphthalene-2-carboxamide]
Details on test material:
Physical state: no data
Analytical purity: no data
Impurities (identity and concentrations): no data
Specific details on test material used for the study:
Physical state: no data
Analytical purity: no data
Impurities (identity and concentrations): no data

Test animals

Species:
rat
Strain:
other: Tif RAI
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: random bred of the TIF RAI strain
- Age at study initiation: young (no further information given)
- Weight at study initiation: 145- 170 g
- Fasting period before study: overnight
- Housing: groups of 5 in macrolon cages
- Diet: Nafag (ad libitum)
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/- 1
- Humidity (%): 55+/- 5
- Photoperiod (hrs dark / hrs light): 10/14

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: sesam oil
Details on oral exposure:
Test substance was suspended in sesam oil at following concentrations 10% for 1000 mg/kg bw
30% for 3000 mg/kg bw and 25% for 10000 mg/kg bw and 15000 mg/kg bw
Doses:
1000, 3000, 10000, 15000 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

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 15 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality was observed
Mortality:
no mortality
Clinical signs:
other: lowest dose (1000 mg/kg): hyperreflexia lasting >6 hours. After 24 hours no symptoms other doses (3000, 10000, 15000 mg/kg): same clinical signs as at lowest dose, additionally reduction in spontanous motility, ataxia, irregular respiration

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met