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Diss Factsheets

Administrative data

Description of key information

The oral LD50 in rats was determined to be greater than 10000 mg/kg body weight. No deaths occurred at any dosage levels used. The LC50 by inhalation in male and female rats exposed to the substance for four hours is greater than 500 mg/m³, air. The dermal LD50 in rats was determined to be greater than 10000 mg/kg body weight. No deaths were caused by the test substance and no outward symptoms of toxicity were observed.

 

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Only short summary available, but results are reported sufficiently for assessment.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
no data
Route of administration:
oral: gavage
Vehicle:
other: suspension of dimethylsulfoxide/propylene glycol
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 10000 mg/kg

DOSAGE PREPARATION:
The test substance was prepared as a suspension in 25 % dimethylsulfoxide/75% propylene glycol, containing the compound at a concentration equivalent to 2500 mg/kg. The 5000 mg/kg level was attained by dosing with 2 times the volume at 2500 mg/kg; 10000 mg/kg by dosing twice at 5000 mg/kg with a 3 hr interval between doses.
Doses:
1250, 2500, 5000 and 10000 mg/kg
No. of animals per sex per dose:
5 animals per group (sex not specified)
Control animals:
not specified
Details on study design:
no data
Preliminary study:
none
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.
Mortality:
no mortality
Clinical signs:
no data
Body weight:
no data
Gross pathology:
no data
Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 was greater than 10000 mg/kg bw
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
10 000 mg/kg bw
Quality of whole database:
No guideline study but acceptable for assessment

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Version / remarks:
2009
Deviations:
yes
Remarks:
Oberservations for only 7 days and not for 14 days, only one concentration level tested.
Principles of method if other than guideline:
Oberservations for only 7 days and not for 14 days, only one concentration level tested.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
other: Tif. RAI
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Own breeding unit
- Age at study initiation: Animals used were 8-9 weeks old
- Weight at study initiation: 195-200 g
- Fasting period before study: not given
- Housing: Segregated by sex and kept in Macrolon cages, type 4 (9 animals to a cage)

ENVIRONMENTAL CONDITIONS
- Temperature: 22 +/- °C
- Humidity: 50 %
Route of administration:
inhalation: aerosol
Type of inhalation exposure:
nose/head only
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Pressure nozzle
- Exposure chamber volume: 10L/min.
- Method of holding animals in test chamber: Kept in separate PVC tubes positioned radially around the exposure chamber.
- Source and rate of air: Compressed air (2 atm.)
- System of generating particulates/aerosols: A 20 % suspension in ethanol of the test substance was injected by a motor-driven syringe at a rate of 60 mL/h into a stream of compressed air flowing through a spray nozzle at a rate of 10 L/min.

TEST ATMOSPHERE
- Brief description of analytical method used: The aerosol was sampled on Membrane Filters, pore size 0.2 µm (Satorius, 34 Göttingen, Germany) in the immediate vicinity of the animals hourly after the beginning of the test.
- Samples taken from breathing zone: yes

VEHICLE
- Composition of vehicle: A 20 % suspension of the test article in ethanol was sprayed into the exposure chamber

TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: The particle-size distribution in the aerosol was determined gravimetrically on Selectron-Filters, pore size 0.2 µm (Schleicher and Schuell, 8714 Feldbach, Switzerland) every hour with the aid of a "Cascade Impactor" (CT. Casella and Co. Ltd., London N.l, England). Results:
> 7 µm = ca. 6%
3-7 µm = ca. 12%
1-3 µm = ca. 35%
< 1 µm = ca. 48%
Analytical verification of test atmosphere concentrations:
yes
Remarks:
Gravimetrically
Duration of exposure:
4 h
Concentrations:
448 +/- 37 mg/m3 (highest possible concentration)
No. of animals per sex per dose:
9 female
9 male
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations: 0-4 h, 24 h, 48 h, 7 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, histopathology
Preliminary study:
none
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 500 mg/m³ air
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: no higher concentrations possible
Mortality:
no mortality
Clinical signs:
other: The rats showed lateral position and apathy after 4h.
Body weight:
not measured
Gross pathology:
No substance related gross organ changes were observed.
Interpretation of results:
GHS criteria not met
Conclusions:
The LC50 of the test material determined after an observation period of 7 days in rats of both sexes, exposed to the substance for four hours is greater than 500 mg/m3 air.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LC50
Value:
500 mg/m³
Quality of whole database:
Comparable to guideline requirements

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Only short summary available, but results are reported sufficiently for assessment.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
not specified
Sex:
not specified
Vehicle:
other: xylene
Details on dermal exposure:
MAXIMUM DOSE VOLUME APPLIED: 10000 mg/kg

VEHICLE
- Amount(s) applied: Small quantity of xylene was used as a binder to allow better application of the test substance to the clipped skins areas
No. of animals per sex per dose:
No of animals: 3 animals per dose (sex not specified)
Control animals:
not specified
Details on study design:
no data
Preliminary study:
none
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.
Mortality:
no mortality occured
Clinical signs:
no data
Body weight:
no data
Gross pathology:
no data
Interpretation of results:
GHS criteria not met
Conclusions:
The dermal LD50 was greater than 10000 mg/kg bw.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
10 000 mg/kg bw
Quality of whole database:
No guideline study but acceptable for assessment

Additional information

Acute toxicity: oral route

An acute oral toxicity study was performed to assess the range of mortality following oral administration of the test material. The nominal concentrations tested were: 1250, 2500, 5000 and 10000 mg/kg body weight. The LD50 was determined to be greater than 10000 mg/kg body weight. Responses to the administered test substance were negligible. No deaths occurred at any dosage levels used. In addition, in a 28d oral repeated dose toxicity study, no deaths were reported upon daily administration of > 2000 mg/kg body weight in feed. Therefore, it can be concluded that the test compound does not possess any acute toxic potential by the oral route.

Acute toxicity: inhalation route

Aim of the study was to provide information on health hazards likely to arise from short-term exposure by the inhalation route. The test substance was tested by the exposure of male and female albino rats to an aerosol generated from this product. A 20% suspension of the test article in ethanol was tested at a concentration of 448 +/- 37 mg/m³. No higher concentrations were possible. The LC50 of the item determined after an observation period of 7 days in rats of both sexes, exposed to the substance for four hours is greater than 500 mg/m³ air. No deaths occurred, the only clinical symptom was lateral position and apathy from which all animals had recovered within 24 hours. No changes were noted during autopsy.

Acute toxicity: dermal route

A study was performed to assess the range of mortality following dermal administration of the test material. A concentration of 10000 mg/kg body weight was tested. The LD50 was determined to be greater than 10000 mg/kg body weight. No deaths were caused by the test substance and no outward symptoms of toxicity were observed.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the substance is not considered to be classified for acute oral, dermal or inhalation toxicity under Regulation (EC) No 1272/2008, as amended for the eighth time in Regulation (EU) No 2016/218.