Benzoic acid, 2-hydroxy-, reaction products with formaldehyde, coupled with diazotized 5-amino-8-[[4-[(4-nitro-2-sulfophenyl)amino]phenyl]azo]-2-naphthalenesulfonic acid disodium salt

Acute Toxicity: oral

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:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Benzoic acid, 2-hydroxy-, reaction products with formaldehyde, coupled with diazotized 5-amino-8-[[4-[(4-nitro-2-sulfophenyl)amino]phenyl]azo]-2-naphthalenesulfonic acid disodium salt

EC Number:

276-521-4

EC Name:

Benzoic acid, 2-hydroxy-, reaction products with formaldehyde, coupled with diazotized 5-amino-8-[[4-[(4-nitro-2-sulfophenyl)amino]phenyl]azo]-2-naphthalenesulfonic acid disodium salt

Cas Number:

72245-24-0

Molecular formula:

not applicable

IUPAC Name:

Benzoic acid, 2-hydroxy-, reaction products with formaldehyde, coupled with diazotized 5-amino-8-[[4-[(4-nitro-2-sulfophenyl)amino]phenyl]azo]-2-naphthalenesulfonic acid disodium salt

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Wistar

Remarks:

Han

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
-Source: KFM, CH-4414 Fullinsdorf, Switzerland
-Weight at study initiation: 160 and 190 g
-Fasting period before study: Access of food only was prevented approximately 18 hours prior and four hours after the dosing. The water bottles were withdrawn two hours prior and four hours after dosing.
-Housing: The rats were housed individually in Macrolon cages.
-Diet: standard laboratory pelleted diet (KLIBA no. 24-343-4 from Klingentalmühle AG., Basle)
-Water: ad libitum
-Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
-Temperature: 23 ± 2 °C
-Humidity: 30 - 70 %
-Air changes: 15 changes/hour
-Photoperiod: 12 hours cycle dark/light

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Amount of vehicle:
Preliminary study: 20 ml/kg body weight
Main study: 20 ml/kg per kg body weight

Doses:

Preliminary study: 5000 mg/kg bw
Main study: 5000 mg/kg bw

No. of animals per sex per dose:

Preliminary study: two per sex per dose
Main study: five per sex per dose

Control animals:

no

Details on study design:

A preliminary study was carried out to establish a dosing regimen.
-Duration of observation period following administration: 14 days
-Observations: animals were observed soon after dosing, then at hourly intervals for the remainder day 1. On the subsequent days the animals were observed once in the morning and once in the late afternoon. Clinical signs were recorded at each observation.
The following was recorded:
1) approximate time of death;
2) the nature, severity, approximate time of onset and duration of each toxic sign
3) individual body weights on day 1, 7 and 14.
-Necropsy of survivors performed: yes
-Other examinations performed: all animals which died during the study and those killed after two weeks were subjected to a macroscopic postmortem examination. The macroscopic appearance of the abnormal organs was recorded.

Results and discussion

Preliminary study:

One female rat has died after exposure. After fourteen hours, during the observation period.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 5 000 mg/kg bw

Based on:

test mat.

Mortality:

- Preliminary study: all males survived; one female died
- Main study: all males survived; three females died 13 hours after dosing.

Clinical signs:

The animals were weak, flaccid and showed a rough coat, tremors, diarrhea, hyperexitability, decreased and labored respiration, and decreased movement.

Gross pathology:

No special findings.

Applicant's summary and conclusion

Interpretation of results:

other: not classified according to the CLP regulation (EC 1272/2008)

Conclusions:

LD50 (oral, rat) ca. 5000 mg/kg body weight

Executive summary:

The acute oral toxicity was evaluated in a test performed on rats similarly to the OECD Guideline 401 method. Based on the results obtained in the preliminary study, five males and five females were dosed by oral gavage at concentration of 5000 mg/kg bw. Animals were observed for 14 days after the treatment and at the end of the study period all animals were necropsied.

The LD50 was found to be about 5000 mg/kg bw.