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Administrative data

Description of key information

The acute oral median lethal doser (LD50) of the test material in the female Spraque-Dawlley CD strain rat was esimtated as being reater than 2500 mg/kg bodywieght, and actue dermal median lethal doser (LD50) as greater than 2000 mg/kg bodywight.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2003
Reliability:
1 (reliable without restriction)
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
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.

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
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.
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 500 mg/kg bw
Quality of whole database:
Klimish 1

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2003
Reliability:
1 (reliable without restriction)
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. certificate)
Test type:
fixed dose procedure
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
After an acclimatisation period of at least five days the animals were selected at random and given a number unique within the study. At the start, the animals weighed at least 200g, and were wight to twelve weeks of age. The animals were housed in susplended solid-floor polypropylene cages furnished with woodflakes. The animals were housed individually during the 24-hour exposure period and in groups of five, by sex, for the remainder of the study.Free access to drinking water and food, which was routinely analyzed was allosed throughout the study. The temp. and relative humidity were set to achieve limits of 19 to 25deg.C adn 30 to 70% respectively.The rate of air exchange was at least 15 changes per hour and the lighing was controlled.
Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
The calculated vo,ume of test material was applied evenly to an aread of sjprm skin (app. 10% of the total body surface) using a graduated syringe.A piece of surgical gauze was placed over the treatment area and semi-occluded with a piece of slef-adhesive bandage. The animals were caged individually for the 24-hour exposure period.
Duration of exposure:
24- hour contact period.
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 animals
Control animals:
not required
Preliminary study:
The acute dermal demida lethal dose (LD50) was found to be greater than 2000 mg/kg.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
There were no deaths.
Clinical signs:
There were no signs of systemic toxicity.
Body weight:
All animals showed expected gains in bodyweght over the study period except for one famale whcih sowned an expceted gain over the first week and bodyweight loss over the second week.
Gross pathology:
No abnormalities were noted at cecropsy.
Conclusions:
The test material does not meet the creiteria for classification and will not require labelling for dermal toxicity in accordance wtih EU regulations.
Executive summary:

Introduction: The study was performed to assess the acute dermal toxicity of the test material in the Spraque-Dawley CD strain rat. The method was designed to meet the requirenments of the following:


-OECD Guidelines for the Testing of Chemicals No. 402 “Acute Dermal Toxicity” (adopted 24 February 1987)
-Commission Directive 92/69/EEC Method B3 Acute Toxicity (Dermal)

Method. A group of ten animals (five males and five females) was given a single, 24-hour, semi-occluded dermal application of undiluted test material to intact skin at a dose level of 2000 mg/kg bodyweight. 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.

Skin Irritation. Very slight or well-defined erythema was noted at the treatment sites of all males and four females one to six days after treatment. Crust formation was noted at three treated skin sites one day after dosing and at nine treated skin sites two to seven days after treatment. One treated skin site appeared normal throughout the study.

Bodyweight. All animals showed expected gains in bodyweight over the study period except for one female which showed an expected gain in bodyweight over the first week and a bodyweight loss over the second week.

Necropsy. No abnormalities were noted at necropsy.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw
Quality of whole database:
Klimish 1

Additional information

Justification for selection of acute toxicity – oral endpoint
Availability of a Klimish 1 study

Justification for selection of acute toxicity – dermal endpoint
Availability of a Klimish 1 study

Justification for classification or non-classification

The test material doesn't meet the criteria for classificaton according to EU lababelling regulations Commission Directive 93/21/EEC as well as CLP.