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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: acceptable, well-documented publication which meets basic scientific principles

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Version / remarks:
Cited as Directive 84/449/EEC, B.1
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:

Na3.NTA.H2O ("TRILON A92"), solid, not further
specified

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
Acclimatization period: at least 1 week. Type of cage: stainless steel wire mesh cages. No. of animals per cage: 5. Animal identification using cage cards. Room temperature/rel. humidity: fully air-conditioned rooms, 20-24°C, 30-70% relative humidity. Day/night rhythm: 12 h. Drinking water: ad libitum. Diet: Kliba-Labordiaet. Animal weights: males 176 - 188 g, females 176 - 182 g. Fasting period: 16 h before administration.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
1000, 1470, 2150, 2610 mg/kg
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
Recording of signs and symptoms several times on the day of administration, at least once each workday. Check for moribund and dead animals twice each workday and once on holidays.
Withdrawal of food 16 hours before sacrifice with CO2; then necropsy with gross-pathological examination. Necropsy of all animals that die as early as possible.

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 740 mg/kg bw
Sex:
female
Dose descriptor:
LD50
Effect level:
1 470 mg/kg bw
Sex:
male
Dose descriptor:
LD50
Effect level:
2 220 mg/kg bw
Mortality:
Males: After 14 d: 2610 mg/kg 3/5, 2150 mg/kg 2/5, 1470 mg/kg 2/5, 1000 mg/kg 0/5
Females: After 14 d: 2610 mg/kg 5/5, 2150 mg/kg 5/5, 1470 mg/kg 3/5, 1000 mg/kg 0/5
Clinical signs:
Dyspnea, apathy, abnormal position, staggering, twitching, opisthotonus, tonic convulsions, piloerection, salivation, poor general state
Gross pathology:
Animals that died: hyperemic glandular-stomach; mucosa with multiple hemorrhagic erosions.
Sacrificed animals: nothing abnormal detected.

Any other information on results incl. tables

No deaths were observed after oral treatment with 1000 mg/kg. Two males and 3 females died after 1470 mg/kg within 2 days, 2 males and all females died after 2150 mg/kg and 3 males and all females died after 2610 mg/kg within 1 day. Surviving animals (observation period 14 days) exhibited dyspnea, apathy and poor general state at day 1. Animals treated with the higher doses showed abnormal position, staggering gait, twitching, opisthotonus, tonic convulsion and salivation in addition to dyspnea and apathy. At necropsy, animals that died within the study demonstrated hyperemic glandular stomach and mucosa with multiple hemorrhagic erosions, in animals sacrificed after 14 days no abnormalities were detected.

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU