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Toxicological information

Acute Toxicity: oral

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Administrative data

acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guidelineopen allclose all
according to guideline
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
The 2000 mg/kg dose level was examined in both sexes, although mortality was observed in the first sex treated. This was due to an interval too short to detect mortality after dosing of the first sex. This deviation has no impact on the study.
according to guideline
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
see above
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:

Test material

Constituent 1
Test material form:

Test animals

other: Wistar outbred; Crl:(WI)WU BR
Details on test animals or test system and environmental conditions:
- Source: Charles River, Germany
- Age at study initiation: 5-6 weeks old upon arrival
- Weight at study initiation: no data available
- Fasting period before study: Prior to dosing, the animals had fasted overnight.
- Housing: a maximum of five animals per stainless steel cage
- Food consumption: standard laboratory rodent diet ad libitum. Each batch of this diet is analyzed by the supplier (SDS Special diets services, Whitham, England).
- Water consumption: Tap water (N.V. Waterleidingbedrijf Midden-Nederland) ad libitum. Results of routine physical, chemical and microbiological examination of drinking water as conducted by the supplier are available upon request.
- Acclimation period: 6 to 9 days

- Temperature: 22 ± 3°C
- Humidity: 30 to 70%
- Air changes: ca 10 air changes/hour
- Photoperiod: 12 h dark/12 h light

In-life dates: From: 17-MAY-2000 To: 22-JUNE-2000

Administration / exposure

Route of administration:
oral: gavage
maize oil
for the concentration 500 mg/lg
Details on oral exposure:
* Vehicle:
- Concentration in vehicle: 500 mg/kg
- Amount of vehicle : 1 mL/kg
- Justification for choice of vehicle: data not available
- Lot/batch no. : data not available
- Purity: data not available

* Maximum dose volume applied: 1 ml/kg body weight of a 500 mg/ml dilution of the test substance in maize oil or 1.74 ml/kg body weight of the undiluted test substance (density 1.15 kg/l)
* Dosage preparation: The exact amount of the test substance to be dosed was calculated for each anamal individually.
* Class method:
- Rationale for the selection of the starting dose: according to the information provided by the Sponsor
500 and 2000 mg/kg/bw
No. of animals per sex per dose:
2 x 3 females + 2 x 3 males
Control animals:
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
> Clinical signs and mortality: Observations were made within 1 hour and within 4 hours after dosing, and subsequently in surviving animals at least once daily throughout an observation period of 14 days.
> Body weight: The body weight of each animal was recorded immediately before dosing on day 0, and of the surviving animals on days 3, 7 and 14 of the study.
- Necropsy of survivors performed: yes
- Other examinations performed: none
not applicable

Results and discussion

Effect levels
Key result
Dose descriptor:
Effect level:
>= 500 - <= 2 000 mg/kg bw
Based on:
test mat.
1/3 male died at 500 mg/kg and all animals (male/female) died at 2000 mg/kg
Male: 500 mg/kg bw; Number of animals: 3; Number of deaths: 1
Male: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 3
Female: 500 mg/kg bw; Number of animals: 3; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 3
Clinical signs:
other: At 500 mg/kg, sluggishness, blepharospam, salivation, lacrimation and, piloerection were observed. At 2000 mk/kg, sluggishness, hunching and, lacrimation were observed.
Gross pathology:
Examination at autopsy of the males and females or of animals that had died did not reveal distinct treatment-related gross alterations.
Other findings:

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Under the experimental conditions of this study, the oral LD50 of the test item Rhodixan A-1 was between 500 and 2000 mg/kg in rats.
Executive summary:

RHODIXAN A-1 was tested for acute oral toxicity in Wistar rats, according to O.E.C.D. guideline N° 423/EEC method B.1ter, and in compliance with Good Laboratory Practice.

The test article, (a liquid, specific gravity: 1.15) was administered by gavage at 500 mg/kg (dose volume: 1 ml/kg, in maize oil) and 2000 mg/kg (dose volume: 1.74 ml/kg, undiluted) to groups of 3 males and 3 females. Examinations for mortality, clinical signs and body weight gain were performed during a 14-day observation period. All surviving animals were euthanatized and necropsied at the end of the observation period.


One male was found dead 2 days after treatment with the 500 mg/kg. All animals treated at 2000 mg/kg died within one day after dosing. Clinical signs consisted mainly of sluggishness, blepharospasm, lacrimation and piloerection. Macroscopic examination of all the animals did not reveal any treatment-related gross changes. All surviving animals gained weight during the 14-day study period.

Based on these results, the LD50 was considered to be between 500 mg/kg and 2000 mg/kg, and RHODIXAN A-1 should be classified Acute toxicity, Oral, Category 4 H302: Harmful if swallowed according to GHS criteria.