Registration Dossier

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

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

Materials and methods

Principles of method if other than guideline:
intra peritoneal injection and subsequent observation
GLP compliance:
no
Remarks:
pre-guideliine study
Limit test:
no

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
Details on test animals or test system and environmental conditions:
- Weight at study initiation:
High dose group: 150 - 180 g (mean 166 g)
Low dose group: 155 - 170 g (mean 162 g)
The animals of the mediium dose group were not weighed.

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
water
Remarks:
deionized water
Doses:
A 50 % mixture of the test item with deionized water was prepared.
High dose group, 5000 mg/kg bw: 1 mL per 100 g bw
Medium dose group, 4000 mg/kg bw: 0.8 mL per 100 g bw
Low dose group, 2000 mg/kg bw: 0.4 mL per 100 g bw
No. of animals per sex per dose:
5 male animals per dose group
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of weighing: the high and low dose group was weighed at the beginning, after 7 days and at the end of the observation period

Results and discussion

Effect levels
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mL/kg bw
Based on:
test mat.
Mortality:
no mortality observed
Clinical signs:
no clinical signs were noted
Body weight:
The animals of the low and high dose group showed expected gains in body weight over the observation period.

Applicant's summary and conclusion

Conclusions:
the acute median lethal dose (LD50) of the test item in male rats by intraperitoneal application 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 toxicity by intraperitoneal application was investigated in three dose groups with 5 male rats respectively. Dose levels of 2000, 4000 and 5000 mg/kg bw were administered as a 50 % mixture of the test item with deionized water. No mortalities were noted.

Thus, the acute 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.