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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:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
not specified
Test type:
other: no data
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Disodium 7-benzamido-4-hydroxy-3-[[4-[(4-sulphonatophenyl)azo]phenyl]azo]naphthalene-2-sulphonate
EC Number:
220-028-9
EC Name:
Disodium 7-benzamido-4-hydroxy-3-[[4-[(4-sulphonatophenyl)azo]phenyl]azo]naphthalene-2-sulphonate
Cas Number:
2610-11-9
Molecular formula:
C29H21N5O8S2.2Na
IUPAC Name:
disodium 7-benzamido-4-hydroxy-3-[(1E)-2-{4-[(1E)-2-(4-sulfonatophenyl)diazen-1-yl]phenyl}diazen-1-yl]naphthalene-2-sulfonate
Test material form:
solid: particulate/powder

Test animals

Species:
rat
Strain:
other: Tif. RAI (SPF)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS- Body weight: from 160 to 180 g- Housing: 5 animals per cage Type 3 Macrolon- Diet: NAFAG, Gossau SG, rat food ad libitum- Water: tap water ad libitum ENVIRONMENTAL CONDITIONS- Temperature (°C): 22 ± 1- Humidity (%): 55 ± 5 %- Photoperiod (hrs dark / hrs light): 14 h light / 14 h dark

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Doses:
4640, 6000, 7750 and 10000 mg/kg
No. of animals per sex per dose:
5 males and 5 females
Control animals:
not specified
Statistics:
No data

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 10 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality for 4640 and 6000 mg/kg. Mortality started after 1 h after the exposure to 7750 mg/kg of the tested item.
Clinical signs:
other: Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, exophthalmus, curved position andruffled fur.
Gross pathology:
No damage or changes to any organs.
Other findings:
No data.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The tested item was found to be non toxic for oral exposure with a LD50 ca 10000 mg/kg bw.
Executive summary:

The acute oral toxicity of Direct Red 81 in rats of both sexes was assessed with this test over a period of 14 days.

The LD50 value was determined using different doses from 4640 mg/kg to 10000 mg/kg of active ingredient.