Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2003
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report Date:
2003

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
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: Liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
A group of three fasted females was treated with the test material at a dose level of 2000 mg/kg bodyweight. This was followed by a further group of three fasted females at the same dose level.
The temp and relative humidity were set to achieve limits of 19 to 25deg C and 30 to 70% respectively. The rate of air axchange was at least 15 changes per hour and the lighting was controlled by a time switch to give 12 hourse continuous light and 12 hours darkenss.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: undiluted
Details on oral exposure:
A group of three fasted females was treated with the test material at a dose level of 2000 mg/kg bodyweight. This was followed by a further group of three fasted females at the same dose level.
Doses:
2000 mg/kg body weight
No. of animals per sex per dose:
A group of three fasted females was treated with the test material at a dose level of 2000 mg/kg bodyweight. This was followed by a further group of three fasted females at the same dose level.
Control animals:
no
Details on study design:
The test material was administered orally undiluted. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.
Statistics:
NA

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 500 mg/kg bw
Based on:
test mat.
Mortality:
Individual mortality data are given in Table 1 in the attachment
Clinical signs:
Individual clinicla observations are given in Table 2 in the attachment.
Body weight:
Individual bodyweight and weekly bodyweight changes are given in Talbe 3 in the attachment. All aanimals showed expected gains in bodyweight over the study period.
Gross pathology:
Individual necropsy findings are given in Table 4 in the attachment. No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
LD50 > 2500 mg/kg body weight.
The test material does not meet the criteria for classification.
Executive summary:


Introduction. The study was performed to assess the acute oral toxicity of the test material following a single oral administration in the Sprague-Dawley CD (Cr!: CD® (SD) IGS BR) strain rat. The method was designed to meet the requirements of the following:

• OECD Guidelines for the Testing of Chemicals No. 423 “Acute Oral Toxicity — Acute Toxic Class Method” (adopted 17 December 2001)

Method. A group of three fasted females was treated with the test material at a dose level of 2000 mg/kg bodyweight. This was followed by a further group of three fasted females at the same dose level.

The test material was administered orally undiluted. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.

Mortality. There were no deaths.

Clinical Observations. There were no signs of systemic toxicity.
Bodyweight. All animals showed expected gains in bodyweight over the study period.

Necropsy. No abnormalities were noted at necropsy.