REAKTIV-ORANGE DYPR 1410

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

20 October 1998 to 03 November 1998

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted to EU & OECD test guidance in compliance with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Details on test material:

Name: Reaktiv-Orange DYPR 1410
Certificate of analysis: NB 208 of December 15, 1998
Content: 73 % (w/w) + 2 %
Appearance: orange powder
Solubility: approx. 350 g/l in water
Batch number: DYPR 1410
Date of production: August 17th 1993
Date of receiving: August 26, 1998
Date of expiry: August 2003
Storage conditions: darkness at approximately 5⁰C in a refrigerator
Stability and homogeneity in the vehicle: is guaranteed for 4 hours

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Species: Sprague Dawley rat
Strain: HSD: Sprague Dawley SO
Origin: HARLAN WINKELMANN Gartenstr. 27, 33178 Borchen SPF breeding colony
Body weight at start of study: male animals: mean = 196g (=100%)
s = ±5.8g
min = 190g (-3.1%)
max = 205g (+4.6%)
n = 5
female animals: mean = 180g (=100%)
s = ±6.2g
min = 170g (-5.6%)
max = 187g (+3.9%)
n = 5
Age at the start of the study: 6 – 10 weeks
Randomization: Randomization schemes 93,0603 and 93,0702
Animal maintenance: in fully air-conditioned rooms in macrolon cages (type 4) on soft wood granulate in groups of 5 animals
Room temperature: 22 ± 3⁰C
Relative humidity: 50 + 20%
Lighting time: 12 hours daily
Acclimatization: at least seven days
Food: ssniff* R/M-H (V 1534), ad libitum
Withdrawal of food: from about 16 hours before to 3 - 4 hours after treatment
Water: tap water in plastic bottles, ad libitum
Animal identification: fur marking with KMnOj and cage numbering

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

deionised

Details on oral exposure:

Test groups
The animals received the compound as a 20 % solution in deionised water, the administration volume being 10 ml/kg body weight.

If no compound-related mortality is produced in this limit test according to the guidelines no full study has to be carried out

Preparation of the test compound
Reaktiv-Orange DYPR 1410 was dissolved in the stated concentration in deionised water and distributed homogeneously by means of a magnetic stirrer.

The stability and the homogeneity of the test substance in the vehicle was determined by analytical methods.

Doses:

The acute oral toxicity of Reaktiv-Orange DYPR 1410 was tested only at a dose level of 2000 mg/kg body weight.

No. of animals per sex per dose:

Male 5
Female 5

Control animals:

no

Details on study design:

The prepared test substance was administered by gavage to fasted animals at the stated dosage. The observation period following treatment fasted for 14 days. Symptoms were recorded twice every day (in the morning and in the afternoon), on weekends and public holidays only once. During this time the animals were weighed weekly. At the end of the observation period the animals were killed by carbon dioxide asphyxiation, dissected and examined for macroscopically visible changes.

Statistics:

Not reported.

Results and discussion

Preliminary study:

Not applicable

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred during the whole study.

Clinical signs:

other: No symptoms were observed after administration of 2000 mg/kg body weight.

Gross pathology:

The animals killed at the end of the observation period showed no macroscopically visible changes.

Other findings:

Only reddish discolored feces were observed in some male and female animals after the administration of Reaktiv-Orange DYPR 1410, At day two of the study all clinical signs were reversible.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the results obtained in this study the median lethal dose value (LD50) of Reaktiv-Orange DYPR 1410 for the male and female rat is greater than 2000 mg/kg body weight.

Executive summary:

A study to assess the acute toxic effects of the test item was conducted in compliance with EEC-Guideline B,1. "Acute Oral Toxicity" of the Directive 92/69/EEC and OECD Guidelines for Testing of Chemicals, 401 “Acute Oral Toxicity”. This study was conducted in compliance with the Principles of Good Laboratory Practice (GLP).

No lethality occurred after administration of 2000 mg/kg body weight. Only reddish discoloured faeces were observed in same male and female animals. At day two of the study all clinical signs were reversible. With exception of one female, which suffered a loss of weight between day 8 and day 15, the body weight of all surviving animals increased during the observation period. The animals killed at the end of the observation period showed no macroscopically visible changes.

Acute oral toxicity testing of Reaktiv-Orange DYPR 1410 in the rat yielded a median lethal dose (LD50) above 2000 mg/kg body weight in both male and female animals. The substance is not classified as acutely harmful by oral exposure.