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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:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
From February 20, 1996 to April 4, 1996
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Read across
Justification for type of information:
Refer to the section 13 for details on the read across justification. The acute oral toxicity study with the read across substance is considered sufficient to fulfil the information requirements as further explained in the provided endpoint summary.
Reason / purpose:
read-across source
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River (UK) Ltd., Margate, Kent, UK
- Age at study initiation: 5-8 wk
- Weight at study initiation: Males - 152 - 182 g, females - 140-156 g
- Fasting period before study: Overnight
- Housing: Groups of up to five by sex in solid-floor polypropylene cages
- Diet: Rat and mouse expanded diet no. 1, ad libitum
- Water: Drinking water, ad libitum
- Acclimation period: Atleast 5 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21
- Humidity (%): 44-65
- Air changes (per h): 15
- Photoperiod (h dark/h light): 12/12

Route of administration:
oral: gavage
Vehicle:
arachis oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 200 mg/mL

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg


Doses:
2,000 mg/kg in both range-finding and main study
No. of animals per sex per dose:
one in range-finding study and five in main study
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 d
- Frequency of clinical observation: 0.5, 1, 2 and 4 h after dosing and subsequently once daily for 14 d
- Frequency of weighing: On Days 0, 7 and 14
- Necropsy of survivors performed: Yes
- Examinations performed: Clinical signs, body weight and gross pathological examination
Preliminary study:
No deaths or clinical signs of toxicity
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality
Clinical signs:
No signs of systemic toxicity
Body weight:
All animals showed an expected gain in body weight except one female which showed reduced body weight gain during the second week of observation
Gross pathology:
No abnormalities noted at necropsy
Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 of the test substance in Sprague-Dawley CD rats was >2,000 mg/kg.
Executive summary:

A study was conducted to determine the acute toxicity of the read across substance, amides, C8-18 and C18-unsatd., N-(hydroxyethyl), to Sprague-Dawley CD rat according to OECD Guideline 401 (standard acute method). A group of 10 fasted rats (five males and five females) were given a single oral dose of the test material as a solution in arachis oil BP at a dose level of 2,000 mg/kg. The animals were observed for 14 d, then sacrificed and subjected to gross pathological examination. There was no mortality and no signs of systemic toxicity were noted during the study. All animals showed an expected body weight gain throughout the study except for one female with reduced body weight gain during the second week. No abnormalities were noted at necropsy. Under the study conditions, the acute oral LD50 of the test substance was > 2,000 mg/kg bw (Hempstock, 1996).

Endpoint:
acute toxicity: oral
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
supporting study
Study period:
Not reported
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Read across
Justification for type of information:
Refer to the section 13 for details on the read across justification. The acute oral toxicity study with the read across substance is considered sufficient to fulfil the information requirements as further explained in the provided endpoint summary.
Reason / purpose:
read-across source
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
2,006 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 d
- Frequency of observations and weighing: Animals were observed for clinical signs at 15 min, 1, 2 and 4 h after administration and daily thereafter for 14 d. Animals were weighed one day prior to dosing, on the day of dosing, on Days 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: Macroscopic observations of the organs were performed following necropsy on Day 15.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 006 mg/kg bw
Based on:
test mat.
Mortality:
No mortality observed
Clinical signs:
No treatment related clinical signs observed
Body weight:
No treatment related changes observed
Gross pathology:
No treatment related macroscopic necropsy findings observed
Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral LD50 of the read across substance was > 2006 mg/kg bw in Sprague Dawley rats
Executive summary:

A limit test was conducted to determine the acute oral toxicity of the read across substance, N-(2-hydroxypropyl)stearamide, in Sprague Dawley rats according to OECD Guideline 401 (standard acute method). The substance was administered as supplied through oral gavage at a single dose of 2006 mg/kg bw to 5 male and 5 female rats. Animals were observed for mortality, clinical signs and change in body weight for 14 d. On Day 15, the rats were necropsied and a macroscopic observation of the organs were carried out. All animals survived until the end of observation period. There were no treatment-related clinical signs or findings in body weight and gross pathology. Under the study conditions, the acute oral LD50 of the test substance was > 2,006 mg/kg bw (Evonik, 1993).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
Adequate

Acute toxicity: via inhalation route

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Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
other justification
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
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:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
Not reported
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Read across
Justification for type of information:
Refer to the section 13 for details on the read across justification. The acute dermal toxicity study with the read across substance is considered sufficient to fulfil the information requirements as further explained in the provided endpoint summary.
Reason / purpose:
read-across source
Qualifier:
according to
Guideline:
other: a modification of the techniques described in Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, compiled by the staff of the Division of Pharmacology, Food and Drug Administration.
Deviations:
not specified
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
- Weight at study initiation: 1.9-2.7 kg

No further information avaialble.
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Prior to dosing, the trunk of each animal was clipped free of hair. Three of the animals (two male, one female) were further prepared by introducing epidermal abrasions over the clipped skin surface to enhance penetrability of the test substance through the stratum corneum. After test substance application the trunk of each animal was encased in a sleeve of plasticized material for 24 h. Following the 24 h exposure period the sleeve was removed and the skin sites gently cleansed.
Duration of exposure:
24 h
Doses:
2,000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
not specified
Details on study design:
All animals were observed daily thereafter for 14 d for mortality, skin response and general behavior.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortalities observed.
Clinical signs:
All animals appeared normal through Day 14.
Body weight:
Two females that had abraded skin lost weight (0.01 and 0.25 kg) over the 14 d post-exposure period. All remaining rabbits gained weight through Day 14.
Interpretation of results:
GHS criteria not met
Conclusions:
Under the study conditions, the acute dermal LD50 of the test substance was > 2,000 mg/kg bw.
Executive summary:

A limit test was conducted to determine the acute dermal toxicity of the read across substance, amides, C8-18 and C18-unsatd., N-(hydroxyethyl), to albino rabbits. Three male and three female rabbits were exposed to a single dose at a level of 2,000 mg/kg bw. Prior to dosing, the trunk of each animal was clipped free of hair. Three of the animals (two male, one female) were further prepared by introducing epidermal abrasions over the clipped skin surface to enhance penetrability of the test substance through the stratum corneum. After test substance application, the trunk of each animal was encased in a sleeve of plasticized material for 24 h. Following the exposure period, the sleeve was removed and the skin sites gently cleansed. All animals were observed daily thereafter for 14 d for mortality, skin response and general behaviour. All animals survived and appeared normal through Day 14. Two females that had abraded skin lost weight over the 14 d post-exposure period. The remaining rabbits gained weight through Day 14. Under the study conditions, the acute dermal LD50 was > 2,000 mg/kg bw (Palanker, 1976).

Endpoint:
acute toxicity: dermal
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
supporting study
Study period:
Not reported
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Read across
Justification for type of information:
Refer to the section 13 for details on the read across justification. The acute dermal toxicity study with the read across substance is considered sufficient to fulfil the information requirements as further explained in the provided endpoint summary.
Reason / purpose:
read-across source
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
not specified
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
other: Hanlbm:WIST (SPF)
Sex:
male/female
Type of coverage:
not specified
Vehicle:
polyethylene glycol
Details on dermal exposure:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 4 mL/kg bw
- Concentration (if solution): 0.5 g/mL
Duration of exposure:
Not reported
Doses:
2,000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 d
- Frequency of observations and weighing: The animals were examined for clinical signs and mortality four time on Day 1 and daily once during Days 2-15. Body weights were recorded Days 1, 8 and 15.
- Necropsy of survivors performed: yes, on Day 15
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed
Clinical signs:
No treatment-related clinical signs observed
Body weight:
Body weights of the test animals remained within the control range for this strain
Gross pathology:
No treatment-related macroscopic changes observed
Interpretation of results:
GHS criteria not met
Conclusions:
Under the study conditions, the dermal LD50 in rats was > 2,000 mg/kg bw.
Executive summary:

A limit test was conducted to determine the acute dermal toxicity of the read across substance, N-(2-hydroxypropyl)stearamide, in SPF rats using a protocol similar to OECD Guideline 402. SPF rats (5 male and 5 females) were administered the test substance at 2,000 mg/kg bw dermally once and observed for mortality, clinical signs and change in bodyweight for 14 d. At test end, the rats were sacrificed and a gross pathological examination conducted. No mortality was recorded and there were no treatment-related clinical signs, changes in body weight or gross pathological findings. Under the study conditions, the dermal LD50 in rats was > 2,000 mg/kg bw (Evonik, 1999).       

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
Adequate

Additional information

Oral

A study was conducted to determine the acute toxicity of the read across substance, amides, C8-18 and C18-unsatd., N-(hydroxyethyl), to Sprague-Dawley CD rat according to OECD Guideline 401 (standard acute method). A group of 10 fasted rats (five males and five females) were given a single oral dose of the test substance as a solution in arachis oil BP at a dose level of 2,000 mg/kg. The animals were observed for 14 d, then sacrificed and subjected to gross pathological examination. There was no mortality and no signs of systemic toxicity were noted during the study. All animals showed an expected body weight gain throughout the study except for one female with reduced body weight gain during the second week. No abnormalities were noted at necropsy. Under the study conditions, the acute oral LD50 of the test substance was >2,000 mg/kg bw (Hempstock, 1996).

A limit test was conducted to determine the acute oral toxicity of the read across substance, isostearic acid monoisopropanolamide, in Sprague Dawley rats according to OECD Guideline 401 (standard acute method). The substance was administered as supplied through oral gavage at a single dose of 2006 mg/kg bw to 5 male and 5 female rats. Animals were observed for mortality, clinical signs and change in body weight for 14 d. On Day 15, the rats were necropsied and a macroscopic observation of the organs were carried out. All animals survived until the end of observation period. There were no treatment-related clinical signs or findings in body weight and gross pathology. Under the study conditions, the acute oral LD50 of the test substance was >2,006 mg/kg bw (Lheritier, 1993).

Dermal

A limit test was conducted to determine the acute dermal toxicity of the read across substance, amides, C8-18 and C18-unsatd., N-(hydroxyethyl), to albino rabbits. Three male and three female rabbits were exposed to a single dose at a level of 2,000 mg/kg bw. Prior to dosing, the trunk of each animal was clipped free of hair. Three of the animals (two male, one female) were further prepared by introducing epidermal abrasions over the clipped skin surface to enhance penetrability of the test substance through the stratum corneum. After test substance application, the trunk of each animal was encased in a sleeve of plasticized material for 24 h. Following the exposure period, the sleeve was removed and the skin sites gently cleansed. All animals were observed daily thereafter for 14 d for mortality, skin response and general behaviour. All animals survived and appeared normal through Day 14. Two females that had abraded skin lost weight over the 14 d post-exposure period. The remaining rabbits gained weight through Day 14. Under the study conditions, the acute dermal LD50 was >2,000 mg/kg bw (Palanker, 1976).

A limit test was conducted to determine the acute dermal toxicity of the read across substance, isostearic acid monoisopropanolamide, in SPF rats using a protocol similar to OECD Guideline 402. The rats (5 male and 5 females) were administered the test substance at 2,000 mg/kg bw dermally once and observed for mortality, clinical signs and change in bodyweight for 14 d. At test end, the rats were sacrificed and a gross pathological examination was conducted. No mortality was recorded and there were no treatment-related clinical signs, changes in body weight or gross pathological findings. Under the study conditions, the dermal LD50 was >2,000 mg/kg bw (Rosner, 1999).   

Justification for classification or non-classification

Based on acute oral and dermal LD50 values >2,000 mg/kg bw, the substance does not require classification for acute endpoints according to CLP (EC 1272/2008) criteria.