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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
Study period:
January 04th, 1996 - February 01th, 1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
Only basic data on study substance given
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: clear, yellowish liquid
- Analytical purity: Not specified
- Purity test date: Not specified
- Lot/batch No.: 1043
- Stability under test conditions: Not specified
- Storage condition of test material: RT

Test animals

Species:
rat
Strain:
other: Hsd/Cpb:WU
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, Germany
- Age at study initiation: Not specified
- Weight at study initiation: 212 - 220 g for males and 165 - 205 g for females
- Housing: 5 animals per Makrolon type III cage
- Fasting period before study: 16 h before until 3 - 4 h after dosing
- Diet (e.g. ad libitum): ad libitum (Ssniff-R Alleindiät, Ssniff Spezialdiäten GmbH, Soest, Germany)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 2.15 ml/kg
Doses:
2000 mg/kg bw taking into account the specific gravity of 0.93 g/ml
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: 10 min, 1 h, 6 h, 24 h, and thereafter once daily up to 14 d, weighing on days 0, 7 and 14
- Necropsy of survivors performed: yes, by CO2 asphyxiation
- Other examinations performed: gross pathology
Statistics:
Not applicable

Results and discussion

Preliminary study:
Single application of 2000 mg/kg bw in two female rats.
No deaths occurred.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality
Clinical signs:
No abnormal clinical signs
Body weight:
Body weight gain was normal on day 7 after application. At day 14, the weight gain was reduced in one male and 2 female rats. In two female rats the body weight was slightly reduced.
Gross pathology:
No apparent abnormalities. Macroscopic changes that were observed were attributed to minor variations which can occur spontaneously in rats of this strain and age.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU