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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
From January 8 to 22, 1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
Source study has reliability 2. The use of a read across approach is considered as acceptable, since target and read across substance differ only in the degree of salification, i.e. monosodium vs. disodium salt.

Data source

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

Materials and methods

Principles of method if other than guideline:
Acute oral toxicity in male and female rats dosed at 5000 mg/kg; observations up to 14 days.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Similar Substance 01
IUPAC Name:
Similar Substance 01
Test material form:
solid: particulate/powder

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 9 - 14 weeks
- Weight at study initiation: 170 g (M), 161 g (F)
- Fasting period before study: from 16 h before dosing up to 4 h after dosing
- Housing: in Makrolon cages type III, in group of 5
- Diet: ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 1.5 °C
- Humidity: 60 ± 5 %
- Photoperiod: 12 h light / 12 h dark

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 20 ml/kg

Doses:
5000 mg/kg
No. of animals per sex per dose:
5
Details on study design:
On the day of application, the animals were inspected several times a day (once on weekends and holidays) twice a day for the following 14-day observation period, recording the type, onset, duration and intensity of the clinical symptoms and possibly removing dead animals.
At the application, after 1 week and at the end of the 14-day observation period, the surviving animals were individually weighed.
All animals killed at the end of the experiment were dissected and assessed pathologically and anatomically.

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD0
Effect level:
5 000 mg/kg bw
Based on:
test mat.
Mortality:
None.
Clinical signs:
No toxicity symptoms.
Gross pathology:
No pathological findings.

Applicant's summary and conclusion

Conclusions:
LD50 > 5000 mg/kg bw.
Executive summary:

Method

Acute oral toxicity in rats was assessed after a single oral dose of 5000 mg/kg by gavage. 5 rat/sex were used; observations were carried out for 14 days after dosing.

Results

No mortality occurred; no toxic symptoms were recorded.

LD0 = 5000 mg/kg bw, LD50 > 5000 mg/kg bw.