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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: Well described, no GLP and no international guideline followed. Read across from a similar substance which has the same main component and with a different counter ion that doesn't influence the characteristics related to the specific end-point

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
not specified
GLP compliance:
no
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen
- Age at study initiation: 98 days old
- Number of animals: 9 males, 14 females
- Weight at study initiation: Males 165 -184 g and females 160-182 g
- Diet: pellet Alrtomin R 1324 ad libitum
- Water: Tap water ad libitum
- Other: all animals were marked into skin by picric acid

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1.5 °C
- Humidity (%): 60 ± 5%
- Photoperiod: 12 H radk/light cycle, artificial light

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
VEHICLE: oral, gavage
Doses:
0.5, 0.8, 1.3, 1.6, 2.0 ml/kg/bw
No. of animals per sex per dose:
5 animal x each sex x dose
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: twice a day
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,
Statistics:
The calculation of the LD-50 for the confidence interval p <0.05 was conducted in accordance with to Rosier et al.J. Tox. Environ. Health 3, 1977, 797th

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 1.2 mL/kg bw
Based on:
test mat.
95% CL:
> 1.1 - < 1.4
Remarks on result:
other: Estimated at 100 %: LD50 = ca 674 mg/Kg bw
Mortality:
All animals are dead by a dose of 5 ml/kg bw. The deaths were within the first 6 days after the application registered.
Clinical signs:
Dose levels between 0.8 to 2.0 ml/kg: in all the animals worsening health and bristling.
At doses ≥ 1.3 ml/kg:: manifest signs of relaxation and abdominal numbness.
At doses ≥ 0.8 ml / kg: growth retardation.
The symptoms occurred about 1 to 2 hours after application and kept in individual animals until the end of the experiment.

Any other information on results incl. tables

Results are expressed as ml/kg; correcting the value following the sample density indicated on the original report (1.123 g/mL) result is LD50 = 674 mg/kg bw

Group Dose [ml/kg bw] Result  Symptoms duration  Dead time Mortality
Males and females
1 0.5 0/0/10 -- -- 0
2 0.8 2/10/10 24h - 14d 3d - 6d 20
3 1.3 5/10/10 2h - 7d 4h - 5d 50
4 1.6 7/10/10 1h - 14d 2h - 3d  70
5 2.0  10/10/10 1h - 2d 2h - 3d 100

Applicant's summary and conclusion

Interpretation of results:
other: CLP: Acute tox 4
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Estimated at 100 %: LD50 = ca 674 mg/Kg bw
Executive summary:

Acute oral toxicity test with MS Astrazon Gruen liquid 50% by administration to gavage on male and female wistar rats.

Estimated at 100 %: LD50 = ca 674 mg/Kg bw