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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

Based on the results of the read across study, the oral LD50 value of the test substance is considered to be 2623 mg a.i./kg bw, indicating a low toxicity potential..

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:
key study
Study period:
1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
only one sex tested, limitations in study reporting
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
Test animals:
- Strain: Hoe WISKf(SPF71)
- Source: Hoechst AG Kastengrund - SPF breed
- Weight at study initiation: 90-112 g (female); (mean = 100 g; n = 60)
- Age at study initiation: no data
- Fasting period before study: 16 hours before and 2 hours after application
- Diet: Altromin 1324 (Altromin GmbH, Lage/Lippe), ad libitum
- Water: Tap water ad libitum
- Acclimatization period: no data

Environmental conditions:
- Housing: in groups, in plastic cages, softwood pellets
Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
Concentration in vehicle: 25 % (w/v)
Doses:
6300, 8000, 9000, 10000, 12500 and 15000 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical observations after application / weighing once weekly
- Necropsy of survivors performed: yes
Statistics:
Probit analysis (method by Linder and Weber); Confidence limits according to Cavalli-Sforza
Preliminary study:
Preliminary experiments did not show differences related to gender. Therefore only females used for main study.
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
10 490 mg/kg bw
Based on:
test mat.
95% CL:
> 9 833 - <= 11 191
Remarks on result:
other: corresponding to 2623 mg a.i./kg bw
Remarks:
with a concentration correction of 25%
Mortality:
Mortality rate:
- 6300 mg/kg bw: 0 / 10
- 8000 mg/kg bw: 0 / 10
- 9000 mg/kg bw: 0 / 10
- 10000 mg/kg bw: 5 / 10
- 12500 mg/kg bw: 9 / 10
- 15000 mg/kg bw: 10 / 10
Clinical signs:
Mortally poisened animals died within 1-2 days after application. Following symptoms were observed: disturbance of equilibrium, spasm. The test substance was vomitted.
Body weight:
Normal body weight gain was observed in all surviving animals.
Gross pathology:
Dissection of rats killed at the end of the observation period revealed no macroscopic findings. Necropsy of the deceased animals revealed following macroscopic findings: stomach and oesophagus were filled with white foam.
Conclusions:
Under the study conditions, the female rat LD50 of the test substance was determined to be 10490 mg/kg bw, corresponding to 2623 mg a.i./kg bw (oral: gavage).
Executive summary:

A study was conducted to determine the acute oral toxicity of the test substance according to OECD guideline 401 (standart acute method). The test substance was administered by gavage to ten female Wistar rats at concentrations of 0, 6300, 8000, 9000, 10000, 12500 and 15000 mg/kg bw (25%, in water). The duration of the observation period following administration was 14 days. Clinical observations were recorded after application and weighing once weekly. Macroscopic examination was performed on all animals. Mortality occurred in the groups 10000, 12500 and 15000 mg/kg bw (5, 9 and 10/10, respectively). Mortally poisened animals died within 1-2 days after application. Disturbance of equilibrium and spasm were observed. The test substance was vomitted. Normal body weight gain was recorded in all surviving animals. Dissection of rats killed at the end of the observation period revealed no macroscopic findings. Necropsy of the deceased animals revealed the following macroscopic findings: stomach and oesophagus were filled with white foam. Under the study conditions, the female rat LD50 of the test substance was determined to be 10490 mg/kg bw, corresponding to 2623 mg a.i./kg bw (1974).

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
From August 04, 2016 to August 31, 2016
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
due to RA
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes
Specific details on test material used for the study:
Batch no.: RE 10-7
Purity/composition: 92.75%
Appearance: lightly yellow paste
Species:
rat
Strain:
Wistar
Remarks:
Crl:WI (Han)
Sex:
female
Details on test animals or test system and environmental conditions:
Source: Charles River Deutschland, Sulzfeld, Germany
Age: approx. 8 weeks old
Acclimatization period: at least 5 days before start of treatment
Temperature and relative humidity: 18 to 24°C and 40 to 70%, respectively.
Light period cycle: 12-hour light/12-hour dark
Diet and water: pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany) and tap water, ad libitum
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
- Method: oral gavage (plastic feeding tubes)
- Fasting: animals were deprived of food overnight prior to dosing and until 3-4 hours after administration of the test substance. Water was available ad libitum.
- Administration. Frequency: single dosage on Day 1. Dose level (volume): 2000 mg/kg (2.06 mL/kg) bw. Dose volume calculated as dose level (g/kg) / specific gravity * (100 / purity (%)).
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
The test substance was administered by oral gavage to two consecutive groups of three female Wistar rats at 2000 mg/kg bw. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (Day 15). (The onset, duration and severity of the signs of toxicity were taken into account for determination of the time interval between the dose groups).
Statistics:
No statistical analysis was performed (the method used is not intended to allow the calculation of a precise LD50 value).
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
No mortality occurred.
Clinical signs:
Piloerection was noted for three animals on Day 1 only.
Body weight:
The mean body weight gain shown by the animals over the study period was considered to be normal.
Gross pathology:
No abnormalities were found at macroscopic post mortem examination of the animals.

The oral LD50 (rats) was established to exceed 2000 mg/kg bw. According to the OECD 423 test guideline, the LD50 cut-off value was considered to exceed 5000 mg/kg bw. Based on these results, the test substance does not have to be classified and has no obligatory labelling requirement for acute oral toxicity according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2015) (including all amendments) and Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments).

Interpretation of results:
GHS criteria not met
Remarks:
Based on these results, the test substance does not have to be classified
Conclusions:
Under the study conditions, the rat oral LD50 for the test substance was established to exceed 2000 mg/kg bw.
Executive summary:

A study was conducted to determine the acute oral toxicity of the test substance according to OECD guideline 423 and EPA OPPTS 870.1100 (acute toxic class method), in compliance with GLP. The test substance was administered by gavage to two consecutive groups of three female Wistar rats at a concentration of 2000 mg/kg bw. Animals were subjected to daily observations and weekly determinations of body weight. Macroscopic examination was performed after terminal sacrifice on Day 15. No mortality occurred. Piloerection were noted for three animals on Day 1 only. The mean body weight gain over the study period was considered to be normal. Finally, no abnormalities were found at macroscopic post mortem examination. Under the study conditions, the rat oral LD50 for the test substance was established to exceed 2000 mg/kg bw (van Huygevoort, 2016). According to the OECD 423 test guideline, the LD50 cut-off value was considered to exceed 5000 mg/kg bw. Based on these results, the test substance does not have to be classified and has no obligatory labelling requirement for acute oral toxicity according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2015) (including all amendments) and Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments).

Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
due to RA
Justification for type of information:
Refer to the section 13 for details on the read across justification. The study with the read across substance is considered sufficient to fulfil the information requirements as further explained in the provided endpoint summary.
Reason / purpose for cross-reference:
read-across: supporting information
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
Test animals:
- Strain: Hoe WISKf(SPF71)
- Source: Hoechst AG Kastengrund - SPF breed
- Weight at study initiation: 90-112 g (female); (mean = 100 g; n = 60)
- Age at study initiation: no data
- Fasting period before study: 16 hours before and 2 hours after application
- Diet: Altromin 1324 (Altromin GmbH, Lage/Lippe), ad libitum
- Water: Tap water ad libitum
- Acclimatization period: no data

Environmental conditions:
- Housing: in groups, in plastic cages, softwood pellets
Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
Concentration in vehicle: 25 % (w/v)
Doses:
6300, 8000, 9000, 10000, 12500 and 15000 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical observations after application / weighing once weekly
- Necropsy of survivors performed: yes
Statistics:
Probit analysis (method by Linder and Weber); Confidence limits according to Cavalli-Sforza
Preliminary study:
Preliminary experiments did not show differences related to gender. Therefore only females used for main study.
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
10 490 mg/kg bw
Based on:
test mat.
95% CL:
> 9 833 - <= 11 191
Remarks on result:
other: corresponding to 2623 mg a.i./kg bw
Remarks:
with a concentration correction of 25%
Mortality:
Mortality rate:
- 6300 mg/kg bw: 0 / 10
- 8000 mg/kg bw: 0 / 10
- 9000 mg/kg bw: 0 / 10
- 10000 mg/kg bw: 5 / 10
- 12500 mg/kg bw: 9 / 10
- 15000 mg/kg bw: 10 / 10
Clinical signs:
Mortally poisened animals died within 1-2 days after application. Following symptoms were observed: disturbance of equilibrium, spasm. The test substance was vomitted.
Body weight:
Normal body weight gain was observed in all surviving animals.
Gross pathology:
Dissection of rats killed at the end of the observation period revealed no macroscopic findings. Necropsy of the deceased animals revealed following macroscopic findings: stomach and oesophagus were filled with white foam.
Conclusions:
Based on the results of the read across study, the female rat LD50 of the test substance was considered to be 10490 mg/kg bw, corresponding to 2623 mg a.i./kg bw (oral: gavage).
Executive summary:

A study was conducted to determine the acute oral toxicity of the read across substance, mono- and di- C12 PSE, K+, according to OECD guideline 401 (standard acute method). The test substance was administered by gavage to ten female Wistar rats at concentrations of 0, 6300, 8000, 9000, 10000, 12500 and 15000 mg/kg bw (25%, in water). The duration of the observation period following administration was 14 days. Clinical observations were recorded after application and weighing once per week. Macroscopic examination was performed on all animals. Mortality occurred in the groups 10000, 12500 and 15000 mg/kg bw (5, 9 and 10/10, respectively). Mortally poisoned animals died within 1-2 days after application. Disturbance of equilibrium and spasm were observed. The test substance was expelled by vomiting. Normal body weight gain was recorded in all surviving animals. Dissection of rats killed at the end of the observation period revealed no macroscopic findings. Necropsy of the deceased animals revealed the following macroscopic findings: stomach and oesophagus were filled with white foam. Based on the results of the read across study, the female rat LD50 of the test substance was considered to be 10490 mg/kg bw, corresponding to 2623 mg a.i./kg bw (Hollander,1974).

Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Study period:
From August 04, 2016 to August 31, 2016
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
due to RA
Justification for type of information:
Refer to the section 13 for details on the read across justification. The study with the read across substance is considered sufficient to fulfil the information requirements as further explained in the provided endpoint summary.
Reason / purpose for cross-reference:
read-across: supporting information
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
Wistar
Remarks:
Crl:WI (Han)
Sex:
female
Details on test animals or test system and environmental conditions:
Source: Charles River Deutschland, Sulzfeld, Germany
Age: approx. 8 weeks old
Acclimatization period: at least 5 days before start of treatment
Temperature and relative humidity: 18 to 24°C and 40 to 70%, respectively.
Light period cycle: 12-hour light/12-hour dark
Diet and water: pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany) and tap water, ad libitum
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
- Method: oral gavage (plastic feeding tubes)
- Fasting: animals were deprived of food overnight prior to dosing and until 3-4 hours after administration of the test substance. Water was available ad libitum.
- Administration. Frequency: single dosage on Day 1. Dose level (volume): 2000 mg/kg (2.06 mL/kg) bw. Dose volume calculated as dose level (g/kg) / specific gravity * (100 / purity (%)).
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
The test substance was administered by oral gavage to two consecutive groups of three female Wistar rats at 2000 mg/kg bw. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (Day 15). (The onset, duration and severity of the signs of toxicity were taken into account for determination of the time interval between the dose groups).
Statistics:
No statistical analysis was performed (the method used is not intended to allow the calculation of a precise LD50 value).
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
No mortality occurred.
Clinical signs:
Piloerection was noted for three animals on Day 1 only.
Body weight:
The mean body weight gain shown by the animals over the study period was considered to be normal.
Gross pathology:
No abnormalities were found at macroscopic post mortem examination of the animals.

The oral LD50 (rats) was established to exceed 2000 mg/kg bw. According to the OECD 423 test guideline, the LD50 cut-off value was considered to exceed 5000 mg/kg bw. Based on these results, the test substance does not have to be classified and has no obligatory labelling requirement for acute oral toxicity according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2015) (including all amendments) and Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments).

Interpretation of results:
GHS criteria not met
Remarks:
Based on these results, the test substance does not have to be classified
Conclusions:
Based on the results of the read across study, the rat oral LD50 for the test substance was established to exceed 2000 mg/kg bw.
Executive summary:

A study was conducted to determine the acute oral toxicity of the read across substance according to OECD guideline 423 and EPA OPPTS 870.1100 (acute toxic class method), in compliance with GLP. The test substance was administered by gavage to two consecutive groups of three female Wistar rats at a concentration of 2000 mg/kg bw. Animals were subjected to daily observations and weekly determinations of body weight. Macroscopic examination was performed after terminal sacrifice on Day 15. No mortality occurred. Piloerection were noted for three animals on Day 1 only. The mean body weight gain over the study period was considered to be normal. Finally, no abnormalities were found at macroscopic post mortem examination. Based on the results of the read across study, the rat oral LD50 for the test substance was established to exceed 2000 mg/kg bw (van Huygevoort, 2016). According to the OECD 423 test guideline, the LD50 cut-off value was considered to exceed 5000 mg/kg bw. Based on these results, the test substance does not have to be classified and has no obligatory labelling requirement for acute oral toxicity according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2015) (including all amendments) and Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments).

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
2 623 mg/kg bw
Quality of whole database:
Guideline equivalent or compliant studies

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
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
Reason / purpose for cross-reference:
data waiving: supporting information
Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Oral

Study 1:

A study was conducted to determine the acute oral toxicity of the read across substance, mono- and di- C12 PSE, K+, according to OECD Guideline 401 (standard acute method). The test substance was administered by gavage to ten female Wistar rats at concentrations of 0, 6300, 8000, 9000, 10000, 12500 and 15000 mg/kg bw (25%, in water). The duration of the observation period following administration was 14 days. Clinical observations were recorded after application and weighing once per week. Macroscopic examination was performed on all animals. Mortality occurred in the groups 10000, 12500 and 15000 mg/kg bw (5, 9 and 10/10, respectively). Mortally poisoned animals died within 1-2 days after application. Disturbance of equilibrium and spasm were observed. The test substance was expelled by vomiting. Normal body weight gain was recorded in all surviving animals. Dissection of rats killed at the end of the observation period revealed no macroscopic findings. Necropsy of the deceased animals revealed the following macroscopic findings: stomach and oesophagus were filled with white foam. Based on the results of the read across study, the female rat LD50 of the test substance was considered to be 10490 mg/kg bw, corresponding to 2623 mg a.i./kg bw (Hollander,1974).

Study 2:

Another more recent supporting acute oral toxicity study is also available, which was conducted with read across substance, mono- and di- iC12 -13 PSE, DEA, according to OECD Guideline 423 and EPA OPPTS 870.1100 (acute toxic class method), in compliance with GLP. The test substance was administered by gavage to two consecutive groups of three female Wistar rats at a concentration of 2000 mg/kg bw. Animals were subjected to daily observations and weekly determinations of body weight. Macroscopic examination was performed after terminal sacrifice on Day 15. No mortality occurred. Piloerection were noted for three animals on Day 1 only. The mean body weight gain over the study period was considered to be normal. Finally, no abnormalities were found at macroscopic post mortem examination. Based on the results of the read across study, the rat oral LD50 for the test substance was established to exceed 2000 mg/kg bw (van Huygevoort, 2016).

Based on the available data from the read across studies, the test substance can be considered to have an oral LD50 exceeding 2000 mg/kg bw, indicating a low acute toxicity potential. The presence of higher fatty alcohol content in the test substance is not expected to have a differential impact on the acute toxicity potential, as available studies with C12 -14 alcohol resulted in oral LD50 values exceeding >2000 mg/kg bw in rats (OECD SIDS, 2006).

Justification for classification or non-classification

Based on the results of read across acute oral toxicity studies, the test substance is assessed not to meet the criteria for classification for acute toxicity according to CLP criteria (Regulation 1272/2008/EC).​