7-aminonaphthalene-1,3,5-trisulphonic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted following OECD guideline, but report does not mention whether GLP was followed and sufficient data is available for interpretation of results.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

Principles of method if other than guideline:

OECD Guideline 423 followed.

GLP compliance:

not specified

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

7-aminonaphthalene-1,3,5-trisulphonic acid

EC Number:

248-394-5

EC Name:

7-aminonaphthalene-1,3,5-trisulphonic acid

Cas Number:

27310-25-4

Molecular formula:

C10H9NO9S3

IUPAC Name:

7-aminonaphthalene-1,3,5-trisulfonic acid

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report):FAT 93527/A
- Physical state: Powder
- Analytical purity: Approx 50%
- Lot/batch No.: 0031026A0
- Expiration date of the lot/batch: 10-JAN-2006
- Storage condition of test material: at room temperature (range of 17-23°C)

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: RCC Ltd, Biotechnology and Animal Breeding Division, CH-4414 Füllinsdorf / Switzerland
- Age at study initiation: Males-8 weeks; Females-10 weeks
- Weight at study initiation: No data
- Fasting period before study: 16-20 hrs
- Housing: In groups of three per sex in Makrolon type-4 cages with wire mesh tops and standardized softwood bedding.
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3433 rat maintenance diet, batch no. 07/00.(Provimi Kliba AG, CH-4303, Switzerland) ad libitum.
- Water (e.g. ad libitum): Community tap-water, from Itingen ad libitum.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 30-70%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

The preparations were made shortly before each dosing.
The test item was weighed into a tared glass beaker on a suitable precision balance and the vehicle added (weight:volume). The mixtures were prepared using a magnetic stirrer or homogenizer, as appropriate.
Homogeneity of the test item in the vehicle was maintained during administration using a magnetic stirrer.

The test item was suspended in vehicle (distilled water) at a concentration of 0.2 g/ml and administered at a volume of 10 ml/kg.
Oral administration was considered to be an appropriate application method as it is a possible route of human exposure during manufacture, handling and use of the test item.

Doses:

Single oral dose of the test item by gavage at 2000 mg/kg body weight

No. of animals per sex per dose:

3 male and 3 female

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: day1, day 8 and day 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology.

Statistics:

No statistical analysis was used.

Results and discussion

Preliminary study:

The animals received a single oral dose of the test item by gavage at 2000 mg/kg body weight after being fasted for 16 to 20 hours.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No death occurred during the study.

Clinical signs:

other: In male no. 5 ruffled fur was noted two hours until five hours after the treatment. This single finding was considered to be test item related and a non toxic effect. All other animals were without clinical signs.

Gross pathology:

No macroscopic findings were observed at necropsy.

Other findings:

None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

LD50 of FAT 93527/A for rat observed over a period of 14 days is >2000mg/kg body weight.

Executive summary:

Following OECD Guidelines for the Testing of Chemicals, Number 423 "Acute Oral Toxicity – Acute Toxic Class Method" wistar rats were exposed to test substance FAT 93527/A to determine median lethal concentration (LD50).

 

3 male and 3 female HanBrl: WIST (SPF) rats were treated by oral gavage with FAT 93527/A at 2000 mg/kg body weight. The test item was suspended in vehicle (distilled water) at a concentration of 0.2 g/ml and administered at a volume of 10 ml/kg.

 

The animals were examined for clinical signs daily during the acclimatization period, four

times during test day 1 and once daily during test days 2-15. Mortality/viability was recorded daily during the acclimatization period and together with clinical signs at the same time intervals on test day 1 and at least once daily on test days 2-15. Body weights were recorded on day 1 (prior to administration) and on days 8 and 15. All animals were necropsied and examined macroscopically.

 

All animals survived until the end of the study period.

In male no. 5 ruffled fur was noted two hours until five hours after the treatment. This single finding was considered to be test item related and a non toxic effect. All other animals were without clinical signs.

 

The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were observed at necropsy.

 

The LD50 dose of FAT 93527/A after single oral administration to rats of both sexes, observed over a period of 14 days is >2000mg/kg body weight.