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Administrative data

Description of key information

The oral LD50 of the substance was found to be greater than 5000 mg/kg bw, while the dermal LD50 was >2000 mg/kg bw.

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:
1976
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
Principles of method if other than guideline:
None
GLP compliance:
not specified
Test type:
fixed dose procedure
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS

- Age at study initiation: 7 weeks
- Weight at study initiation: 220 g (males) and 166 g (females)
- Diet (e.g. ad libitum): Dakes special diet added with Vitamin E ad libitum
- Water (e.g. ad libitum): water was available at all times

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C (+/- 2°C)
- Photoperiod (hrs dark / hrs light): 12 hours artificial light and 12 hours darkness in each 24 hour period.
Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
After administration of the compound, the animals were observed for 14 days. Deaths and clinical symptoms were recorded. At the end of the observation period, surviving animals were killed by exsanguination under ether anaesthesia and an autopsy performed.
Doses:
A 25 % w/v solution of the compound in tap water was administered as a single dose by gavage to rats which had been fasted for 18 hours, at a rate of 20 ml/kg. (equivalent to 5 g/kg of compound).
No. of animals per sex per dose:
Ten rats (5 M + 5 F) were used for the study.
Control animals:
no
Details on study design:
None
Statistics:
None
Preliminary study:
None
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
No mortality observed.
Clinical signs:
No clinical symptoms were recorded and no deaths occurred during the 14-day observation period.
Body weight:
None
Gross pathology:
At autopsy no changes in organs or tissues caused by the administration of the test compound were seen.
Other findings:
None

None

Interpretation of results:
other: Not classified as toxic according to the CLP Regulation (EC) No.1272/2008
Conclusions:
The acute oral median lethal dose (LD50) of the substance in rats is greater than 5000 mg/kg body weight.
Executive summary:

The test was performed to determine the acute oral toxicity of the substance according to the equivalent or similar OECD guideline 401 (Acute Oral Toxicity). It was tested on rats which were 6 to 7 weeks old and weighed about 166 to 220 g. No clinical symptoms were recorded and no deaths occurred during the 14 day observation period. At autopsy no changes in organs or tissues caused by the administration of the test compound were seen. In conclusion, the acute oral LD50 of the substance in rats of both sexes, observed over a period of 14 days is greater than 5000 mg/kg.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
exposure considerations
Justification for data waiving:
the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
Clinical signs:
other:
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:
1971
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: basic data given, acceptable for assessment
Principles of method if other than guideline:
None
GLP compliance:
no
Test type:
fixed dose procedure
Limit test:
no
Species:
rabbit
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
Kaninchen: Gelbsilber
Tierzahl, Sex/Dosis: 3M 3F
Tierzahl pro Käfig: 1
Tierhaltung: konventionell, klimatisierter Raum: Temperatur 23+2°C, relative Luftfeuchtigkeit 55+/- 5%, 14 Lichtstunden/Tag
Futter: Nafag Würfel Nr. 84
Applikation: Enthaaren der Rückenhaut durch Scheren.
Einmalige Applikation auf intakte Haut. Occlusiv-Verband (Methode
nach Draize) während 24 Stunden.
Abwaschen der Applikationsfläche mit lauwarmem Wasser und Schwamm.
Fläche: 200 - 300cm2
Volumen: 2.5 ml/kg
Beobachtungszeit: 8 Tage
200-300 cm2
2,5 ml/kg
8 Tage
Type of coverage:
not specified
Vehicle:
not specified
Details on dermal exposure:
None
Duration of exposure:
None
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3 M and 3 F
Control animals:
not specified
Details on study design:
None
Statistics:
None
Preliminary study:
None
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
2000 mg/kg: 6/6: day 1-8: no symptoms related to resorption
24 h; 4/6: Erythema
2.-6. Tag: 6/6: no observations
7.+8. Tag: 1/6: scaling
Body weight:
None
Gross pathology:
None
Other findings:
None

None

Interpretation of results:
other: Not classified as toxic according to the CLP Regulation (EC) No.1272/2008
Conclusions:
The acute dermal LD50 of the test substance the substance was found to be >2000 mg/kg bw.
Executive summary:

The acute dermal toxicity of the substance was performed on rabbits. However, no mortality was observed throughout the observation period. Hence, the acute dermal LD50 of the test substance was found to be >2000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

The animal studies demonstrated that the test item has low oral toxicity.


The key study describing the acute oral toxicity did not find any mortality up to the maximum dose tested. Hence, the acute LD50 was found to be >5000 mg/kg bw.


In a supporting study describing the acute oral toxicity of the test item, no mortality was observed even at the maximum dose tested, hence the LD50 is considered to be > 15000 mg/kg bw.


Similar to acute oral toxicity data, the available animal acute dermal toxicity study demonstrated that the substance has low dermal toxicity. The key study describing the acute dermal toxicity of the substance did not find lethality up to the maximum dose tested and the LD50 was >2000 mg/kg bw.

Justification for classification or non-classification

Based on the above stated assessment of the acute oral toxicity thesubstance does not need to be classified for Acute Oral toxicity according to CLP (Regulation (EC) No 1272/2008 Of The European Parliament And Of The Council) as implementation of UN-GHS in the EU.