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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Qualifier:
no guideline followed
Principles of method if other than guideline:
Toxic properties after a single oral dose of the test substance were investigated by observation for a period of 15 days.
GLP compliance:
no
Limit test:
yes
Species:
guinea pig
Strain:
not specified
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
other: sunflower-seed oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 20-45%
- Amount of vehicle (if gavage):0.2-0.5 mL/kg bw
- Justification for choice of vehicle: because of low solubility of the substance



Doses:
0.2 to 0.5 mL/kg bw of 20-45% solution in the vehicle
No. of animals per sex per dose:
6 animals/sex/dose
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 15 days
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 4 500 mg/kg bw
Based on:
test mat.
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008
Conclusions:
The test substance has a LD50 of 4500 mg/kg bw given as a single dose.
Executive summary:

The study has been performed in order to investigate the toxic propreties of the test substance.

Each groups of 6 males and 6 females of guinea pigs were fed through a stomach tube perorally in the form of a 20 -45% solution in sunflower-seed oil (0.2 - 0.5 mL per kg bw) given as a single dose.

The animals were observed for 15 days.

No differences in the sex sensitivity of these animals were observed.

As a result, the test substance can be referred to as a low-toxic compound with an LD50 of 4500 mg/kg bw.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Qualifier:
no guideline followed
Principles of method if other than guideline:
Toxic properties after a single oral dose of the test substance were investigated by observation for a period of 15 days.
GLP compliance:
no
Limit test:
yes
Species:
mouse
Strain:
other: White/CD-1
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
other: sunflower-seed oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 20-45%
- Amount of vehicle (if gavage):0.2-0.5 mL/kg bw
- Justification for choice of vehicle: because of low solubility of the substance



Doses:
0.2 to 0.5 mL/kg bw of 20-45% solution in the vehicle
No. of animals per sex per dose:
6 animals/sex/dose
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 15 days
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 4 500 mg/kg bw
Based on:
test mat.
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008
Conclusions:
The test substance has a LD50 of 4500 mg/kg bw given as a single dose.
Executive summary:

The study has been performed in order to investigate the toxic propreties of the test substance.

Each groups of 6 males and 6 females of White/CD-1 mice were fed through a stomach tube perorally in the form of a 20 -45% solution in sunflower-seed oil (0.2 - 0.5 mL per kg bw) given as a single dose.

The animals were observed for 15 days.

No differences in the sex sensitivity of these animals were observed.

As a result, the test substance can be referred to as a low-toxic compound with an LD50 of 4500 mg/kg bw.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Qualifier:
no guideline followed
Principles of method if other than guideline:
Toxic properties after a single oral dose of the test substance were investigated by observation for a period of 15 days.
GLP compliance:
no
Limit test:
yes
Species:
rat
Strain:
other: Albino
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
other: sunflower-seed oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 20-45%
- Amount of vehicle (if gavage):0.2-0.5 mL/kg bw
- Justification for choice of vehicle: because of low solubility of the substance



Doses:
0.2 to 0.5 mL/kg bw of 20-45% solution in the vehicle
No. of animals per sex per dose:
6 animals/sex/dose
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 15 days
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 4 500 mg/kg bw
Based on:
test mat.
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008
Conclusions:
The test substance has a LD50 of 4500 mg/kg bw given as a single dose.
Executive summary:

The study has been performed in order to investigate the toxic propreties of the test substance.

Each groups of 6 males and 6 females of albino rats were fed through a stomach tube perorally in the form of a 20 -45% solution in sunflower-seed oil (0.2 - 0.5 mL per kg bw) given as a single dose.

The animals were observed for 15 days.

No differences in the sex sensitivity of these animals were observed.

As a result, the test substance can be referred to as a low-toxic compound with an LD50 of 4500 mg/kg bw.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Principles of method if other than guideline:
No detailed information is available on the test method.
GLP compliance:
no
Limit test:
yes
Species:
rat
Strain:
not specified
Sex:
not specified
Route of administration:
oral: unspecified
Vehicle:
not specified
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Other examinations performed: clinical signs
Sex:
not specified
Dose descriptor:
LD50
Effect level:
5 000 mg/kg bw
Mortality:
5 out of 10 animals died on day 1.
Clinical signs:
Lethargy
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008
Conclusions:
The test item tested via oral route has an LD50 of 5000 mg/kg bw.
Executive summary:

In the current test the acute toxicity via the oral route of the test item was assessed in rats. A single dose of 5000 mg/kg bw of the test substance was given to 10 animals. 5 out of 10 animals died and therefore the LD50 is 5000 mg/kg bw.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Principles of method if other than guideline:
No detailed information is available on the test method.
GLP compliance:
no
Limit test:
yes
Species:
mouse
Strain:
not specified
Sex:
not specified
Route of administration:
oral: unspecified
Vehicle:
not specified
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: daily
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
No animals died.
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008
Conclusions:
The LD50 for acute oral toxicity was greater than 5000 mg/kg bw.
Executive summary:
In the current test the acute toxicity of the test item via the oral route was assessed in mice. A single dose of 5000 mg/kg bw of the test substance was given to 10 animals. No animals died and therefore the LD50 > 5000 mg/kg bw.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
4 500 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Principles of method if other than guideline:
No information on test method available.
GLP compliance:
no
Limit test:
yes
Species:
rabbit
Strain:
not specified
Sex:
not specified
Type of coverage:
not specified
Vehicle:
not specified
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10 animals in total
Control animals:
not specified
Sex:
not specified
Dose descriptor:
LD50
Effect level:
>= 5 000 mg/kg bw
Mortality:
0/10
Clinical signs:
Diarrhea in 2 animals out of 10 on day 1.
Slight redness in 2 out of 10 animals; slight edema in 1 out of 10.
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008
Conclusions:
The test item tested via dermal route had an LD50 greater than 5000 mg/kg bw
Executive summary:

In the current test the acute toxicity via the dermal route of the test item was assessed in rabbits. A single dose of 5000 mg/kg bw of the test substance was applied to 10 animals. No animals died and therefore the LD50 > 5000 mg/kg bw. Slight erythema was observed in 2/10 animals, slight edema in 1/10. Furthermore, 2 rabbits had diarrhea on day 1.

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Principles of method if other than guideline:
No information on test method available.
GLP compliance:
no
Limit test:
yes
Species:
rabbit
Strain:
not specified
Sex:
not specified
Type of coverage:
not specified
Vehicle:
not specified
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
4 animals in total
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Other examinations performed: skin reactions (erythema, edema)
Sex:
not specified
Dose descriptor:
LD50
Effect level:
>= 5 000 mg/kg bw
Mortality:
No animals died.
Clinical signs:
No erythema or edema observed.
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008
Conclusions:
The test item tested via dermal route had an LD50 greater than 5000 mg/kg bw.
Executive summary:

In the current test the acute toxicity via the dermal route of the test item was assessed in rabbits. A single dose of 5000 mg/kg bw of the test substance was applied to 4 animals. No animals died and therefore the LD50 > 5000 mg/kg bw. No erythema or edema was observed.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

Acute oral toxicity

There are 5 studies available assessing the acute toxicity of the test item via the oral route.

None of these studies is performed according to internationally accepted guidelines, and the documentation of the test method and results is in general limited. The studies are therefore all assigned a Klimisch 4 score. Nevertheless, as the outcome of all studies consistently shows a very low acute toxicity, a weight of evidence approach is used in order to fulfil the information requirements for this endpoint, and to determine the classification of the test substance. Additional testing is deemed to not bring new information to the acute toxicity assessment, and hence is omitted in order to avoid unnecessary vertebrate animal testing.

The publication by Zaitsev (1973) addresses the oral acute toxicity to rats, mice and guinea pigs by dosing the test substance dissolved in sunflower-seed oil via oral gavage. 3 Male and 3 female animals were dosed per experiment. The animals were observed for 15 days following the single exposure. Each of these 3 experiments resulted in an LD50 value of 4500 mg/kg bw.

In the second study (Leberco Laboratories, 1975) a single dose of 5000 mg/kg bw was given to 10 rats, none of which died. Hence, the LD50 was determined to be > 5000 mg/kg bw.

In the third study (MB Research Laboratories, 1975) a single dose of 5000 mg/kg bw of the test substance was given to 10 rats. 5 Out of 10 died, leading to the conclusion that the LD50 is 5000 mg/kg bw.

The above experiments allow to conclude by weight of evidence that the substance exerts only low acute oral toxicity. Classification according to the CLP Regulation No 1272/2008 is not necessary as the LD50 is higher than 2000 mg/kg bw.

Acute dermal toxicity

There are 2 studies available assessing the acute toxicity of the test item via the dermal route. The documentation on the study method and results is limited, hence a Klimisch 4 score is deemed appropriate. In the first test, 10 rabbits were exposed to 5000 mg/kg bw and were observed for 14 days (MB Research Laboratories, 1975). In the second study the same dose was tested on 4 rabbits (Leberco Laboratories, 1975). In both experiments no animals died in the course of the observation period. Hence, the dermal LD50 of the test item was found to be >5000 mg/kg bw. As a consequence, classification according to the CLP Regulation No 1272/2008 is not necessary. These results further prove the low acute toxicity of the test substance.

Justification for classification or non-classification

Acute oral toxicity

According to the CLP legislation a substance is considered acute toxic when the acute toxicity estimates (ATE) for the oral route are =< 2000 mg/kg bodyweight. As the LD50 of the test item > 2000 mg/kg bw, the substance has not to be classified as acute toxic for the oral route.

Acute dermal toxicity

According to the CLP legislation a substance is considered acute toxic when the acute toxicity estimates (ATE) for the dermal route are =< 2000 mg/kg bodyweight. As the LD50 of the test item > 2000 mg/kg bw, the substance has not to be classified as acute toxic for the dermal route.