Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
poor documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report date:
1973

Materials and methods

Test guideline
Qualifier:
no guideline followed
Version / remarks:
Study pre-dates creation of guidelines, but a method similar to OECD 401 is likely
Principles of method if other than guideline:
Treatment of rats via gavage with subsequent observation
GLP compliance:
no
Remarks:
pre-guideline study
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Disodium 4-amino-3-[[4-[(2-amino-4-hydroxyphenyl)azo]phenyl]azo]-5-hydroxy-6-(phenylazo)naphthalene-2,7-disulphonate
EC Number:
270-629-5
EC Name:
Disodium 4-amino-3-[[4-[(2-amino-4-hydroxyphenyl)azo]phenyl]azo]-5-hydroxy-6-(phenylazo)naphthalene-2,7-disulphonate
Cas Number:
68460-07-1
Molecular formula:
C28H22N8O8S2.2Na
IUPAC Name:
disodium 4-amino-3-({4-[(2-amino-4-hydroxyphenyl)diazenyl]phenyl}diazenyl)-5-hydroxy-6-(phenyldiazenyl)naphthalene-2,7-disulfonate
Constituent 2
Chemical structure
Reference substance name:
Disodium 4-amino-3-[[4-[(2,4-diaminophenyl)azo]phenyl]azo]-5-hydroxy-6-(phenylazo)naphthalene-2,7-disulphonate
EC Number:
272-559-0
EC Name:
Disodium 4-amino-3-[[4-[(2,4-diaminophenyl)azo]phenyl]azo]-5-hydroxy-6-(phenylazo)naphthalene-2,7-disulphonate
Cas Number:
68877-33-8
Molecular formula:
C28H23N9O7S2.2Na
IUPAC Name:
disodium 4-amino-3-({4-[(2,4-diaminophenyl)diazenyl]phenyl}diazenyl)-5-hydroxy-6-(phenyldiazenyl)naphthalene-2,7-disulfonate

Test animals

Species:
rat
Strain:
not specified
Sex:
male

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
dionized
Details on oral exposure:
- Concentration in vehicle: ca. 33 %
- Amount of vehicle (if gavage): 15 mL per kg bw
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
not specified
Control animals:
not specified

Results and discussion

Effect levels
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
no mortality observed
Clinical signs:
none reported

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Regulation (EC) no 1272/2008
Conclusions:
The acute oral median lethal dose (LD50) of the test item in male rats was determined to be greater than 5000 mg/kg body weight (Globally Harmonized Classification System - Unclassified).
The test item did not meet the criteria for classification according to Regulation (EC) No. 1272/2008.
Executive summary:

In a pre-guideline study the acute oral toxicity was investigated in white male rats.

The acute oral median lethal dose (LD50) of the test item in male rats was determined to be greater than 5000 mg/kg body weight (Globally Harmonized Classification System - Unclassified).

The test item did not meet the criteria for classification according to Regulation (EC) No. 1272/2008.