Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
16 OCT 1996 - 30 OCT 1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
The study was performed in compliance with the Good Laboratory Practice (GLP) regulations (revised in 1997, ENV/MC/CHEM(98)17).The method followed that described in the OECD Guidelines for Testing of Chemicals (Adopted: 4 April 1984) No 401 "Acute Oral Toxicity".

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)
Version / remarks:
Feb 1987
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: solid: wax-like

Test animals

Species:
rat
Strain:
Wistar
Remarks:
HsdCpb: WU
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: F. Winkelmann, 33178 Borchen
- Females (if applicable) nulliparous and non-pregnant: not mentioned
- Age at study initiation: approx. 7 to 9 weeks
- Weight at study initiation: 170 (161-182) g
- Fasting period before study: yes, diet was withheld from 17 hours before until up to 4 hours after treatment
- Housing: The rats were kept separately in type III Makrolon cages with a shelter, placed on mobile racks. Conventional softwood granulate was used as the bedding. One day before treatment, and up to 24 hours after dosing, metal grids were placed above the softwood granulate. The cages and the metal grids had been machine-cleaned before the start of the experimental part. The bedding was changed two times per week
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 to 24 °C
- Humidity (%): relative atmospheric humidity 45 to 75 %.
- Air changes (per hr): air-conditioned room of about 25 m2
- Photoperiod (hrs dark / hrs light): 12 hour light - 12 hour dark regime

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
paraffin oil
Details on oral exposure:
The rats received the test material preparation orally by means of a stomach tube.

VEHICLE
- Concentration in vehicle: 100 g/L
- Amount of vehicle (if gavage): 20 mL/kg

MAXIMUM DOSE VOLUME APPLIED: 2 mL/100 g
Doses:
2000 mg/kg bw (limit test)
No. of animals per sex per dose:
5 (m) / 5 (f)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The behavior and general condition of all rats were monitored for at least 6 hours after the administration and then checked daily. All animals were weighed before treatment and on days 2, 4, 6, 8, 11, 13, and 15 of the experimental part.
- Necropsy of survivors performed: yes, all rats were sacrificed at the end of the experimental part by CO2-asphyxia and subjected to gross pathological investigations
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:
Statistics:
Standard statistical methods have been applied for data processing.

Results and discussion

Preliminary study:
Only wet anal region was observed on day one after treatment. Thus the study was performed as limit test.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality observed. All rats survived the observation period.
Clinical signs:
Only wet anal region was observed on day one after treatment. No further signs of toxicity were detected in the 5 male and 5 female rats after treatment with 2000 mg/kg of the test item.
Body weight:
Body weight development of the treated rats was normal.
Gross pathology:
At necropsy no organ alterations were seen.
Other findings:
None

Applicant's summary and conclusion

Interpretation of results:
other: EU GHS criteria not met
Conclusions:
According to the results of this study the test materials' LD50 value is expected to exceed 2000 mg/kg.
Executive summary:

The acute oral toxicity of the test item was determined in a limit test according to OECD 401 and following GLP.

Purpose

The purpose of this assay was to provide information on possible health hazards for the test material and serve as a rational basis for risk assessment to the potential of acute oral toxicity of the test item in man.

Study design

The test material was tested for acute toxicity in rats after oral administration of 2000 mg/kg body weight. Directly before the administration the test material was prepared with liquid paraffin as vehicle. This study was performed at a fixed dose of 2000 mg/kg bw (limit test).

Results

Only wet anal region was observed on day one after treatment. No further signs of toxicity were detected in the 5 male and 5 female rats after treatment with 2000 mg/kg bw of the test material. All rats survived the observation period. Body weight development of the treated rats was inconspicuous. At necropsy no organ alterations were seen.

Conclusions

According to the results of this study the test material can be allocated to ATC class 0 i.e. the LD50 value is expected to exceed 2000 mg/kg.