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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:
since 17th April 2007 to 14th May 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study well documented, test procedure in accordance with OECD 420 methods, meets generally accepted scientific principles, acceptable for assessment. GLP compliant.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report date:
2007

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
GLP compliance:
yes
Test type:
fixed dose procedure

Test material

Constituent 1
Reference substance name:
hexasodium 6-amino-3-[(E)-2-{7-[(E)-2-{4-[(E)-2-(4-amino-2-hydroxy-6-sulfonaphthalen-1-yl)diazen-1-yl]phenyl}diazen-1-yl]-8-hydroxy-6-sulfonaphthalen-2-yl}diazen-1-yl]-4-hydroxynaphthalene-2-sulfonate 6-amino-3-[(E)-2-{7-[(E)-2-{4-[(E)-2-(4-amino-6-sulfonaphthalen-1-yl)diazen-1-yl]phenyl}diazen-1-yl]-8-hydroxy-6-sulfonaphthalen-2-yl}diazen-1-yl]-4-hydroxynaphthalene-2-sulfonate
EC Number:
941-225-2
Molecular formula:
not applicable
IUPAC Name:
hexasodium 6-amino-3-[(E)-2-{7-[(E)-2-{4-[(E)-2-(4-amino-2-hydroxy-6-sulfonaphthalen-1-yl)diazen-1-yl]phenyl}diazen-1-yl]-8-hydroxy-6-sulfonaphthalen-2-yl}diazen-1-yl]-4-hydroxynaphthalene-2-sulfonate 6-amino-3-[(E)-2-{7-[(E)-2-{4-[(E)-2-(4-amino-6-sulfonaphthalen-1-yl)diazen-1-yl]phenyl}diazen-1-yl]-8-hydroxy-6-sulfonaphthalen-2-yl}diazen-1-yl]-4-hydroxynaphthalene-2-sulfonate
Test material form:
solid - liquid: suspension

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female

Administration / exposure

Route of administration:
oral: feed
Vehicle:
arachis oil
Details on oral exposure:
Following a sighting test in which there were no mortalities at dose level of 300 and 2000 mg/kg, a further group of four fasted females was given a single oral dose of test material, as a suspension in arachis oil BP at a dose level of 2000 g/kg bw.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
4 females
Details on study design:
Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.

Results and discussion

Preliminary study:
Dose level - 300 mg/kg: there were no deaths. No sign of systemic toxicity were noted during the study. The animal showed expected gains in bodyweight over the study period. No abnormalities were noted at necropsy.
Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality
Clinical signs:
No sign of systemic toxicity were noted during the study. Black stained faeces was noted in four animals.
Body weight:
Animals showed expected gains in bodyweight over the study period.
Gross pathology:
No abnormalities were noted at necroscopy.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 of the test material in the female Sprague-Dawley CD strain rat was estimated to be greater than 2000 mg/kg bw.
The test material was considered to have no significant acute toxicity risk if swallowed and did not meet the criteria for classification according to EU Regulation (EC) No 1272/2008 for classification and labelling of dangerous substances.
Executive summary:

Direct Black 80 was tested according to OECD 420.

Following a sighting test in which there were no mortalities at dose level of 300 and 2000 mg/kg, a further group of four fasted females was given a single oral dose of test material, as a suspension in arachis oil BP at a dose level of 2000 g/kg bw.

Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.

LD50 of the test material in the female Sprague-Dawley CD strain rat was estimated to be greater than 2000 mg/kg bw and therefore can be

considered as non toxic.