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Key value for chemical safety assessment

Acute toxicity: via oral route

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Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Principles of method if other than guideline:
Groups of 6 males were administered 0, 5000, 10000 and 20000 mg/kg bw of the test substance by stomach intubation. The animals were observed for 14 d.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: male: 150-250 g
- Fasting period before study: 24 h
- Housing: Screen bottom cages
- Diet (e.g. ad libitum): Laboratory chow (ad libitum)
- Water (e.g. ad libitum): ad libitum
Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
Six adult SD rats per dose group were given the test substance by stomach intubation.
Doses:
0, 5000, 10000 and 20000 mg/kg.
No. of animals per sex per dose:
Males: 6/dose/group
Control animals:
not specified
Details on study design:
Male SD rats were fasted for 24 h and then administered single doses of the test substance by stomach intubation followed by 14 d of observation period.
Statistics:
No data
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
ca. 10 000 mg/kg bw
Based on:
test mat.
Mortality:
Number of dead/number dosed:
- No mortality occured at lowest dose of 5000 mg/kg, i.e., 0/6
- 50% mortality was observed In the mid dose group of 10000 mg/kg, i.e., 3/6
- Almost all animals died in the highest dose group of 20000 mg/kg, i.e., 5/6.

None.

Interpretation of results:
GHS criteria not met
Conclusions:
Under the study conditions, the oral LD50 in rats was found to be 10000 mg/kg bw.
Executive summary:

A study was conducted to determine the acute oral toxicity of the test substance, C18-unsatd. DEA, in Sprague Dawley rats. Groups of 6 males were administered 0, 5000, 10000 and 20000 mg/kg bw by stomach intubation and observed for 14 d. Approximately 50% mortality occurred at the mid dose. Under the study conditions, the oral LD50 in rats was found to be 10000 mg/kg bw (Casey, 1976).

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Principles of method if other than guideline:
Groups of 20 fasted animals (10 males and 10 females) were exposed via oral gavage to 0, 10.0, 12.6, 16.0 and 20.0 mL/kg bw. The animals were observed for 14 d, then sacrificed and subjected to gross pathological examination.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: W. Gassner, Sulzfeld, Germany
- Weight at study initiation: males: 95 - 115 g; females: 90 - 110 g
- Fasting period before study: ca. 16 h
- Temperature: 22 +/- 1°C
- Housing: 5 animals/cage
- Lighting cycle (light:dark): 12:12
- Feed: Ssniff (pellets)
- Water: ad libitum
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
0, 10.0, 12.6, 16.0 and 20.0 mL/kg bw
No. of animals per sex per dose:
10
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 d
- Necropsy of survivors performed: Yes
- Examinations performed: Clinical signs, body weight and gross pathological examination
Statistics:
LD50 was calculated according to Kärber (Toxikologie für Veterinärmediziner, H.J. Hapke, 1975) and Weil (Biometrics 8, 249; 1952).
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 14.21 mL/kg bw
Based on:
test mat.
Remarks on result:
other: Equivalent to 14210 mg/kg bw; assuming the density to be approx. 1 g/cm3
Remarks:
(according to Kärber)
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 13.82 mL/kg bw
Based on:
test mat.
Remarks on result:
other: Equivalent to 13820 mg/kg bw; assuming the density to be approx. 1 g/cm3
Remarks:
(according to Weil)
Mortality:
0% at 0 and 10.0 ml/kg bw
40% at 12.6 mL/kg bw
70% at 16.0 mL/kg bw
100% at 20.0 mL/kg bw
Clinical signs:
other: Rough fur, pale extremities, diarrhea, increased lacrimation and slight to middle-strong lethargy and ataxia.
Gross pathology:
ANIMALS DYING DURING THE STUDY:
- Light to medium hyperemia and hemorragic edema in the lung.
- Light to medium hyperemia of the liver
- Light to medium hyperemia of the mucous membrane of the glands and the cutaneous mucous membrane of the stoimach
- Light to medium hyperemia of the mucous membrane of the duodenum

ANIMALS SACRIFICED AT THE END OF THE STUDY:
- Medium hyperemia and light hemorragic edema of the lungs
- Light to medium hyperemia of the liver
- Local thickeniung of the cutaneous mucous membrane of the stomach



Other findings:
None.

None.

Interpretation of results:
GHS criteria not met
Conclusions:
Under the study conditions, the LD50 of the test substance was found to be equivalent to 14.21 mL/kg bw (according to Kärber) or 13.82 ml/kg bw (according to Weil). These LD50 values are equivalent to 14210 and 13820 mg/kg bw, assuming a density of approximately 1 g/cm3.
Executive summary:

A study was performed to assess the acute oral toxicity of the test substance, C18-unsatd. DEA (purity not specified), in Sprague Dawley rats. Groups of 20 fasted animals (10 males and 10 females) were exposed via oral gavage to 0, 10.0, 12.6, 16.0 and 20.0 mL/kg bw. The animals were observed for 14 d, then sacrificed and subjected to gross pathological examination. Mortality occured at 12.6 mL/kg bw. Signs of toxicity included rough fur, pale extremities, diarrhea, increased lacrimation and slight to middle-strong lethargy and ataxia. Animals dying during the study showed slight to medium effects in the lung, liver, glands, stomach and duodenum. In animals sacrificed at the end of the study, light to medium effects were observed in the lungs, liver and stomach. Under the study conditions, the LD50 of the test substance was found to be equivalent to 14.21 mL/kg bw (according to Kärber) or 13.82 ml/kg bw (according to Weil). These LD50 values are equivalent to 14210 and 13820 mg/kg bw, assuming a density of approximately 1 g/cm3 (Sandhowe-Grote, 1979).

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
10 000 mg/kg bw

Acute toxicity: via inhalation route

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Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Clinical signs:
other: other:
Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

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Reference
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:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Justification for type of information:
Refer to the section 13 for details on the category justification.
Qualifier:
according to guideline
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 or test system 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:
2000 mg/kg bw
No. of animals per sex per dose:
3
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
Mortality:
No mortalities observed.
Clinical signs:
other: All animals appeared normal through Day 14.
Gross pathology:
Not evaluated.
Other findings:
Not evaluated.

None.

Interpretation of results:
GHS criteria not met
Conclusions:
Under the study conditions, the acute dermal LD50 in rabbits was found to be >2000 mg/kg bw.
Executive summary:

A study was conducted to determine the acute dermal toxicity of the read across substance, C8-18 and C18-unsatd. DEA, in male/female New Zealand White rabbits. The procedure was the 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. A single dose of 2000 mg/kg bw of test substance was applied to the abraded and intact skin of the test animals. The trunk of each animal was then encased in a sleeve of plasticized material for a 24 h period. Animals were observed immediately after dosing, and at 1, 6 and 24 h post-dosing. Following the 24 h exposure period, animals were observed for mortality, skin response and general behaviour for 14 d. No mortality occurred. All animals appeared normal throughout the 24 h exposure and 14 d post-exposure observation periods. Under the study conditions, the dermal LD50 in rabbits was found to be > 2000 mg/kg bw (Palanker, 1976).

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

Additional information

Oral

A study was conducted to determine the acute oral toxicity of the test substance, C18-unsatd. DEA, in Sprague Dawley rats. Groups of 6 males were administered 0, 5000, 10000 and 20000 mg/kg bw by stomach intubation and observed for 14 d. Approximately 50% mortality occurred at the mid dose. Under the study conditions, the oral LD50 in rats was found to be 10000 mg/kg bw (Casey, 1976).

A study was performed to assess the acute oral toxicity of the test substance, C18-unsatd. DEA, in Sprague Dawley rats. Groups of 20 fasted animals (10 males and 10 females) were exposed via oral gavage to 0, 10.0, 12.6, 16.0 and 20.0 mL/kg bw. The animals were observed for 14 d, then sacrificed and subjected to gross pathological examination. Mortality occured at 12.6 mL/kg bw. Signs of toxicity included rough fur, pale extremities, diarrhea, increased lacrimation and slight to middle-strong lethargy and ataxia. Animals dying during the study showed slight to medium effects in the lung, liver, glands, stomach and duodenum. In animals sacrificed at the end of the study, light to medium effects were observed in the lungs, liver and stomach. Under the study conditions, the LD50 of the test substance was found to be equivalent to 14.21 mL/kg bw (according to Kärber) or 13.82 mL/kg bw (according to Weil). These LD50 values are equivalent to 14210 and 13820 mg/kg bw, assuming a density of approximately 1 g/cm3 (Sandhowe-Grote, 1979).

Dermal

A study was conducted to determine the acute dermal toxicity of the read across substance, C8-18 and C18-unsatd. DEA, in male/female New Zealand White rabbits. The procedure was the 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. A single dose of 2000 mg/kg bw of test substance was applied to the abraded and intact skin of the test animals. The trunk of each animal was then encased in a sleeve of plasticized material for a 24 h period. Animals were observed immediately after dosing, and at 1, 6 and 24 h post-dosing. Following the 24 h exposure period, animals were observed for mortality, skin response and general behaviour for 14 d. No mortality occurred. All animals appeared normal throughout the 24 h exposure and 14 d post-exposure observation periods. Under the study conditions, the dermal LD50 in rabbits was found to be > 2000 mg/kg bw (Palanker, 1976).

Justification for classification or non-classification

The available data indicates that C18-unsatd. DEA has a low potential for acute toxicity (oral and dermal LD50 >10000 and >2000 mg/kg bw, respectively). The substance therefore does not meet the requirement for classification according to CLP (EC 1272/2008) criteria.