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Diss Factsheets

Administrative data

Description of key information

The acute toxicity via the oral and dermal route was investigated in studies performed according to OECD/EC guidance and GLP principles. The results indicate low acute toxicity.

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:
22 Feb 2007 (Date of Project Protocol) - 11 Apr 2007 (Date of Report)
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
2001
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Version / remarks:
Directive 96/54 EEC B.1.tris.
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Version / remarks:
2002
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: EPA Health Effects Test Guidelines, OPPTS 870.1000 "Acute toxicity testing background", EPA 712-C-02-189
Version / remarks:
2002
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes
Specific details on test material used for the study:
Storage: at room temperature
Species:
rat
Strain:
Wistar
Remarks:
HsdRccHan: WIST rats
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann GmbH, D-33178 Borchen , Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Weight at study initiation: 148-228g (step 1); 149-155g (step 2)
- Housing: the animals were kept in Macrolon cages on Altromin saw fiber bedding
- Diet: feeding ad libitum, Altromin 1324 (TPF)
- Water: free acces to tap water
- Acclimation period: adequate acclimatization period

ENVIRONMENTAL CONDITIONS
- Temperature: 22±3°C
- Humidity: 55 ±10%
- Air changes: 10x / hour
- Photoperiod (hrs dark / hrs light): 12 / 12
Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
Test item was admistered in a single dose by gavage using an intubation cannula. The test item was administered at a volume of 10 mL/kg body weight.

Doses:
2000 mg/kg body weight
No. of animals per sex per dose:
Step 1: 3 females;
Step 2: 3 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were weighed prior to the administration and once a week thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Cageside observations included changes in the skin and fur, eyes and mucous systems and somatomotor activity and behaviour pattern were examined. Particular attention was directed to observations of tremor, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred.
Clinical signs:
other: No treatment related effects were observed in any animal.
Gross pathology:
No treatment related effects were observed in any animal.
Interpretation of results:
GHS criteria not met
Conclusions:
Based on the results of an oral toxicity study performed according to OECD/EC guidelines and GLP principles, the substance was found to be of low oral toxicity (LD50 > 2000 mg/kg bw/day).
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
> 2 000 mg/kg bw
Quality of whole database:
A reliable study is available (Klimisch 1 study).

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:
22 Feb 2007 (Date of Project Protocol) - 11 Apr 2007 (Date of Report)
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
1998
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure
Limit test:
yes
Specific details on test material used for the study:
Storage conditions: at room temperature
Species:
rat
Strain:
Wistar
Remarks:
HsdRccHan : WIST rats
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann GmbH, D-33178 Borchen, Germany
- Weight at study initiation: 217-226g (male); 194-199g (female)
- Housing: the animals were kept in Macrolon cages on Altromin saw fiber bedding
- Diet: feeding ad libitum, Altromin 1324 (TPF)
- Water: free acces to tap water
- Acclimation period: adequate acclimatization period

ENVIRONMENTAL CONDITIONS
- Temperature: 22±3°C
- Humidity: 55±10%
- Air changes: 10x / hour
- Photoperiod (hrs dark / hrs light): 12 / 12
Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 24 hours before the test, fur was removed from the dorsal area of the trunk by clipping.
- % coverage: approx. 10% of the total body surface
- Type of wrap if used: the test item was held in contact with the skin wih a cauze-dressing and non-irritating tape and was fixed with an additional dressing in a suitable manner.

REMOVAL OF TEST SUBSTANCE
At the end of the exposure (24 h), residual test item was removed by using tap water.

TEST MATERIAL
The test item was applied at a single dose (2000 mg/kg bw) by appling uniformly over an area which was approx. 10% of the total body surface.
Duration of exposure:
24 h
Doses:
single dose (2000 mg/kg bw) on an area which was approx. 10% of the total body surface
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: the animals were weighed prior to application and once a week thereafter.
- Necropsy of survivors performed: yes

A careful clinical examination was made at least twice on the day of dosing and once a day thereafter.
Cageside observations included changes in the skin and fur, eyes and muscous membranes. Also respiratory, circulatory, autonomic and central nervous systems and somatomotor activity and behaviour pattern were examined. Particular attention was directed to observations of tremor, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred.
Clinical signs:
other: No treatment related effects were observed
Gross pathology:
No treatment related effects could be observed.
Other findings:
No treatment related effects were observed.

Weight Gain in g (dose: 2000 mg/kg)

 Animal No. / Sex  Day 0  Day 7  Day 14
 1 male 226   259  289
 2 male 223  261  291
 3 male  217  244  264
 4 male  224  257  290
 5 male  226  255  282
 1 female  195  206  214
 2 female  194  204  209
 3 female  198  210  217
 4 female  194  201  214
 5 female  199  209  220
Interpretation of results:
GHS criteria not met
Conclusions:
Based on the results of an acute dermal toxicity study performed according to OECD/EC guidelines and GLP principles, the dermal LD50 was concluded to be >2000 mg/kg bw.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
> 2 000 mg/kg bw
Quality of whole database:
A reliable study is available (Klimisch 1 study).

Additional information

Justification for classification or non-classification

Based on the available results, the test substance is not classified for acute oral and dermal toxicity according to Regulation (EC) No 1272/2008.