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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

acute toxicity: oral
Type of information:
other: read across from similar substance
Adequacy of study:
key study
Study period:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
equivalent or similar to guideline
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
Test type:
acute toxic class method
Limit test:

Test material

Constituent 1
Chemical structure
Reference substance name:
Disodium 7-amino-4-hydroxy-3-[[4-[(4-sulphonatophenyl)azo]phenyl]azo]naphthalene-2-sulphonate
EC Number:
EC Name:
Disodium 7-amino-4-hydroxy-3-[[4-[(4-sulphonatophenyl)azo]phenyl]azo]naphthalene-2-sulphonate
Cas Number:
Molecular formula:
disodium 7-amino-4-hydroxy-3-({4-[(4-sulfonatophenyl)diazenyl]phenyl}diazenyl)naphthalene-2-sulfonate

Test animals

Details on test animals or test system and environmental conditions:
Adult, young, albino, Wistar ITA177 SPF strain are used. Rats have been bred and kept in rooms with spf conditioning. The temperature is 24+-1 ° C and the humidity is 65+-5%.
The lighting is artificial, following periods of light and darkness of 12 h.

Administration / exposure

Route of administration:
oral: gavage
CMC (carboxymethyl cellulose)
Details on oral exposure:
All rats remain fasting approximately 18 hours before and 4 hours after administration. The rest of the time they received UAR D-04 sterilized feed and demineralised water "as libitum".
Rats are administered orally by means of a esophageal probe, the product suspended or dissolved in a solution of 1% tween 80 and 2% carboxymethylcellulose in distilled water.
Liquid products, if possible, are given undiluted.
Dose levels are chosen in progression and the products are administered according to the individual body weights of the rats (mg / kg or ml / kg).
The maximum dose used is 16 mg / kg or 16 ml / kg. The volume administered when using vehicle is 10 ml / kg. At high doses, the volume can be increased to a maximum of 40 ml / kg to facilitate the suspension of the product.
The control group receives only vehicle at the maximum volume administered.
4 mg/kg bw, 8 mg/kg bw, 11.3 mg/kg bw, 16 mg/kg bw
No. of animals per sex per dose:
10 animals per dose
Control animals:
Details on study design:
Body weights are recorded for each rat immediately prior to administration, and thereafter at weekly intervals.
Animals are often observed on the day of the administration, and then at least once a day for 14 days.
Symptoms of reaction to treatment are recorded in terms of approximate time of onset, duration and intensity.
The circumstances of each death are recorded and the autopsy performed, which includes the opening of the abdominal and thoracic cavities, as well as the cranial cavity if the observations indicate neurotoxic activity. The organs are examined microscopically and the observed alterations are noted.
All surviving animals at the end of the observation period are sacrificed and undergo the same autopathic examination.
The 14-day observation period will be extended if the general condition of the animals is not considered satisfactory or if delayed toxicity is noted.
The LD50 value is calculated from the mortality data found using the method of Litchfield and Wilcoxon.

Results and discussion

Preliminary study:
The preliminary study has an experimental design similar to the one of the study, but using a smaller number of animals (2 males and 2 females per group).
If the LD50 is found to be equal to or greater than 16 g / kg (16 ml / kg in the case of liquid) during the preliminary study, the exact value of LD50 is not determined.
If LD50 is found to be only slightly lower than 16 g / kg (16 ml / kg in the case of liquids), its value is determined even if four dose levels are not administered.
Effect levelsopen allclose all
Key result
Dose descriptor:
Effect level:
14.8 mL/kg bw
Based on:
act. ingr.
Key result
Dose descriptor:
Effect level:
2 516 mg/kg bw
Based on:
act. ingr.
The day after the adminsitration the observed mortality was:
Dose 16ml/kg: 60% (4 males, 2 females)
Dose 11,3 ml/kg: 20% (1 male, 1 female)
Dose 8 ml/kg: 10% (1 male)
Dose 4 ml/kg: 0%
Clinical signs:
Not observed
Body weight:
Body gain
Gross pathology:
Not observed

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
The substance has been found to have a LD50 of 14.8 (11.3-19.3) ml / kg when administered orally.
Rats died on the first day after administration without showing external signs of toxicity. There were no macroscopic alterations at autopsies.