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Diss Factsheets

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
19 June 2001 to 30 August 2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: JMAFF Acute Oral Toxicity Study, 2000
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
4-amino-3,6-dichloropyridine-2-carboxylic acid
EC Number:
604-721-7
Cas Number:
150114-71-9
Molecular formula:
C6H4Cl2N2O2
IUPAC Name:
4-amino-3,6-dichloropyridine-2-carboxylic acid
Test material form:
solid: particulate/powder
Details on test material:
- Appearance: tan powder
Specific details on test material used for the study:
Purity: 94.5%

Test animals

Species:
rat
Strain:
Fischer 344
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: Approximately 11 weeks
- Weight at study initiation: 130 - 291 g
- Fasting period before study: rats were fasted the night prior to treatment. Feed was provided to all rats immediately following administration of the test material.
- Housing: Animals were housed two or three per cage in stainless steel cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: At least one week

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 40 - 70 % (relative)
- Air changes: 12 - 15 air changes per hour
- Photoperiod: 12 hours of darkness / 12 hours of light (06:00 to 18:00)

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
methylcellulose
Details on oral exposure:
Five male and five female Fischer 344 rats received the test material at a dose of 5000 mg/kg body weight as a 50 % mixture in 0.5 % aqueous methylcellulose in two fractional doses approximately one hour apart.
Doses:
5000 mg/kg as a 50 % mixture in vehicle
No. of animals per sex per dose:
5 males and 5 females per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: A Detailed Clinical Observation (DCO) was conducted for all rats prior to test material administration for comparison with the observations recorded throughout the study. Animals were observed a minimum of two times on the day of treatment. A DCO was done each day (including weekends and holidays) during the study. Hand-held and open-field observations included a careful physical examination. Each animal was weighed pre-study, on the day of treatment, and on test days 2, 8, and 15.
- Necropsy of survivors performed: Yes, necropsy was performed on all animals. Animals were anaesthetised by inhalation of carbon dioxide and euthanised by decapitation after clamping of the trachea.
- Other examinations performed: The eyes were examined in situ using a moistened glass microscope slide applied to the corneal surface. Following inspection of the externum and body orifices, the nasal, cranial, oral, thoracic, and abdominal cavities were opened and the visceral organs were examined both in situ and following dissection, and tissues were not saved.
Statistics:
Means and standard deviations were calculated for body weights. The data were evaluated for statistical outliers by a sequential test (Grubbs, 1969); however, outliers were not routinely excluded from statistical analysis.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
One male died on study day 3. All other animals survived the duration of the study.
Clinical signs:
other: Clinical observations for the male that died were consistent with the rat’s moribund condition. Clinical observations of high incidence for the surviving rats consisted of various combinations of: perineal soiling (9 of 9 rats), watery faeces (7 of 9 rats
Gross pathology:
The male rat that died had treatment-related gross findings consisting of haemolysed blood and gas in the gastrointestinal tract and perineal soiling. The haemolysed blood was consistent with a stress-induced alteration. Surviving animals had no treatment-related gross pathologic observations.

Any other information on results incl. tables

Table 1: Mean body weights

Sex

Days on test

-1

1

2

8

15

Male

276.2

257.8

248.1

269.6

293.4

Female

151.9

139.6

141.0

152.6

163.0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this study, the acute oral LD50 of the test material in male and female Fischer 344 rats was greater than 5000 mg/kg.
Executive summary:

The acute oral toxicity of the test material was investigated in a study which was conducted under GLP conditions and in accordance with the standardised guidelines OECD 401, EU Method B.1, EPA OPPTS 870.1100 and JMAFF (2000).

During the study, five male and five female Fischer 344 rats received test material at a dose of 5000 mg/kg body weight as a 50 % mixture in 0.5 % aqueous methylcellulose by single dose gavage. Parameters evaluated during the two-week observation period included body weights, detailed clinical observations, and gross pathological changes.

Under the conditions of this study, the acute oral LD50 of the test material in male and female Fischer 344 rats was greater than 5000 mg/kg.