Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD) (test substance purity not specified).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
, adopted 24 Feb 1987
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Version / remarks:
, adopted 31 July 1992
GLP compliance:
yes (incl. certificate)
Remarks:
ToxLabs Prüflabor GmbH
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Epicol G24 G2, C12/14alpha-Epoxid, ringgeöffnet mit Glykol, SAT 970397
- Physical state: colorless liquid
- Analytical purity: not specified
- Lot/batch No.: 10017020
- Expiration date of the lot/batch: 1998-01-20
- Storage condition of test material: room temperature in a closed vessel

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH, Germany
- Age at study initiation: 40 - 44 days
- Weight at study initiation: mean body weight: male: 195.5 g ± 9.3 g, female: 157.4 g ± 8.3 g
- Fasting period before study: 16 hours before application and 3 hours after
- Housing: in Makrolon Type 3 cages, 1 animal per cage
- Diet: Altromin Laboratory Standard diet for rats and mice, ALTROMIN 1326, ad libitum
- Water: Community Tap water in Makrolon water bottles, ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 - 25 °C
- Humidity (%): 50 -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: 0.22 mL/100g body weight
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: continously on the day of observation and once daily thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortalities were observed
Mortality:
The control and also the treated animals showed no mortality in the course of investigation.
Clinical signs:
The control and also the treated animals showed no clinical signs in the course of investigation.
Body weight:
The body weight gain of the animals was not influenced by administration of the test substance.
Gross pathology:
There were no substance dependent macroscopic pathological findings in the control and the treated animals.

Applicant's summary and conclusion

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