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Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
April, 1977
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 reliablity 2. Details on the read across are attached in section 13.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978

Materials and methods

Principles of method if other than guideline:
5/mouse/sex were dosed by a single intraperitoneal dose of 2000 mg/kg; observation were carried out for 14 days after dosing.
GLP compliance:
no
Limit test:
no

Test material

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

Test animals

Species:
mouse
Strain:
CD-1
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River (U.K.) Ltd.
- Weight at study initiation: 17 - 24 g
- Fasting period before study: for 18 - 20 hours before treatment
- Housing: in groups of 5 by sex
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 3 days.

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 50 ± 10 %
- Photoperiod: natural light conditions

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
water
Details on exposure:
A single intraperitoneal dose (2000 mg/kg) of test material, based on the individual fasted body weight of the animais at the time of treatment.
Doses:
2000 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations for overt toxicity and mortality at 15 min, 1, 2 and 4 hours after treatment and subsequently once daily for 14 days; body weights of survivors were recorded 14 days after treatment.
- Necropsy of survivors performed: no
- Other examinations performed: no

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
EC50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
EC0
Effect level:
ca. 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None.
Clinical signs:
No signs of overt toxicity.
Body weight:
Normal body weight gain.

Applicant's summary and conclusion

Conclusions:
LD50 > 2000 mg/kg.
Executive summary:

Method

Acute intraperitoneal toxicity was assessed by dosing 5 mice/sex/dose by intraperitoneal route at dose of 2000 mg/kg. Observations were carried out for 14 days after dosing.

Results

No deaths occurred and no signs of overt toxicity were noted, thus LD50 > 2000 mg/kg.