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Diss Factsheets

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:
From 2011-12-05 to 2011-12-26
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 425 (Acute Oral Toxicity: Up-and-Down Procedure)
relative humidity 18 to 61%, 1 animal not weighed at time of death
according to guideline
EPA OPPTS 870.1100 (Acute Oral Toxicity)
GLP compliance:
Test type:
up-and-down procedure
Limit test:

Test material

Constituent 1
Test material form:
Specific details on test material used for the study:
- Name of test material (as cited in study report): XTJ-568
- Substance type: Clear colorless liquid
- Physical state: liquid
- Analytical purity: 97% (primary amine)
- Composition of test material, percentage of components: water (0.03%), acetylatable (9.2 meq/g), total amine (8.7 meq/g)
- Lot/batch No.: 0G704
- Stability under test conditions: no data
- Storage condition of test material: 21 - 26.7°C

Test animals

Details on test animals or test system and environmental conditions:
- Source: Harlan
- Age at study initiation: 9 to 10 weeks at start of dosing; records of dates of birth for animals used in this study are retained in the Calvert archives.
- Weight at study initiation: 191 - 202 grams
- Fasting period before study: Animals were fasted overnight prior to dose administration.
- Housing: Animals were group housed by sex upon receipt and individually housed upon assignment to study in compliance with the National Research Council " Guide for the Care and Use of Laboratory Animals". Calvert is a USDA registered and fully AAALAC accredited facility. The room in which the animals were kept was documented in the study records. no other species were kept in the same room.
- Diet (e.g. ad libitum): ad libitum with fasting overnight prior to dose administration
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days prior to dosing

- Temperature (°C): 19 to 22°C
- Humidity (%): 18 to 61%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark

Administration / exposure

Route of administration:
oral: gavage
unchanged (no vehicle)
Details on oral exposure:
Dose preparation: An initial preparation of the test article in distilled water resulted in an undoseable suspension with a pH of 13. Therefore, the proper amount of the test article was measured according to volume since it was a liquid, and was allocated/dosed neat as received from the Sponsor with a pH of 10. The stock bottle was inverted several times prior to dispensing.

Dose volumes (specific density 1 g/ml): 0.32, 0.55, 1 and 2 ml/kg.
320, 550, 1000 or 2000 mg/kg
No. of animals per sex per dose:
A total of six rats received the substance.
Control animals:
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
mortality/morbidity: manually recorded once daily
clinical observations: clinical observations were collected manually. On the day of dosing (Day 1) animals were observed prior to dosing and approximately 30 minutes and 4 hours post-dose. Animals were observed once daily thereafter (Days 2-15).
body weight: Animal weights were manually recorded prior to dosing on Day 1, and on Day 8 and 15, or upon death.
- Necropsy of survivors performed: yes. The necropsy included examination of: the external body surface, all orifices, the cranial, thoracic and abdominal cavities and their contents. All surviving animals were euthanized by CO2 asphyxiation.
The LD50 was calculated for the main test using AOT425StatPgm developed by Westat May, 2001.

Results and discussion

Effect levels
Key result
Dose descriptor:
Effect level:
1 000 mg/kg bw
Based on:
test mat.
95% CL:
>= 275.7 - <= 2 580
Mortality was not observed in any of the animals dosed at 320 or 550 mg/kg of the substance. Two of three animals receiving the test article at 1000 mg/kg were found dead as well as the single animal dosed at 2000 mg/kg.
Clinical signs:
other: Clinical observations observed included piloerection at 30 minutes in the single animal at 320 mg/kg and in the surviving animal at 1000 mg/kg. no clinical signs were observed prior to death in the two other animals at 1000 mg/kg. Piloerection, decreased
Gross pathology:
Terminal necropsy revealed no visible lesions in the animals at 320, 550 or the surviving animal at 1000 mg/kg. Necropsy of two animals found dead at 1000 and 2000 mg/kg revealed dark red fluid-filled intestines. The third animal found dead had no visible lesions.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Based on the results of this study, the oral LD50 for the substance in rats was estimated to be 1000 mg/kg (95% PL Confidence interval of 275.7 to 2580 mg/kg). The substance is considered classified as acute oral toxicant category 4 according to the criteria laid down in the CLP Regulation (EC) 1272/2008.