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Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

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Referenceopen allclose all

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
From October 8, 1985 to October 23, 1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Mollegaard Breeding Centre Ltd, Ejby, DK-4623 LI. Skensved.
- Weight at study initiation: 148±3 g
- Fasting period before study: 18 h
- Housing: Housed in Macrolone cages Type III (42x26x15 cm) in groups of 2 or 3 per cage (males and females separated)
- Diet: Complete rodent diet - Altromin 1314, ad libitum
- Water: Drinking water acidified with hydrochloric acid to pH 2.5, ad libitum
- Acclimation period: No acclimatization as the rats were born in the laboratory and had been kept in the same environment during the experiment

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±2
- Humidity (%): 55±15
- Air changes (per h): 10
- Photoperiod: 6-18 h of light

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Maximum dose volume applied: 5 mL/kg

Rationale for the selection of the starting dose: A range-finding study was conducted, which indicated that LD50 would exceed 5000 mg/kg (details not reported)
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
Five
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 d
- Frequency of clinical observations: 1, 3 and 6 h after administration and daily thereafter once or twice for 14 d
- Frequency of weighing: Day 0, 7 and 14
- Necropsy of survivors performed: Yes
Statistics:
None
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Remarks on result:
other: (equivalent to >2400 to 2800 mg a.i./kg bw)
Mortality:
No mortality
Clinical signs:
Sedation and piloerection were observed in all the rats shortly after treatment. All rats recovered completely by Day 2, except for one female, which showed pilorection till Day 7. This rat also showed pinched abdomen on Days 4, 5 and 6.
Body weight:
Except for one female rat which showed a low body weight gain throughout the experiment, all other rats had a normal body weight gain throughout the experiment.
Gross pathology:
No macroscopic organ changes were observed, except for one rat (same animal which showed low body weight gain), in which the kidneys were presented with enlarged size, plumpy shape and light and pale tissue on macroscopic observation.
Other findings:
None.

None.

Interpretation of results:
GHS criteria not met
Conclusions:
Under the study conditions, the LD50 in rats was >5000 mg/kg bw (equivalent to >2400 to 2800 mg a.i./kg bw).
Executive summary:

A study was performed to assess the acute oral toxicity of the test substance, C8-18 and C18-unsatd. DEA (48 - 56% active), in Wistar rats according to OECD Guideline 401. A group of 10 fasted animals (five males and five females) was given a single oral dose of test substance at a dose level of 5000 mg/kg bw. The animals were observed for 14 d after dosing, then sacrificed and subjected to gross pathological examination. Clinical signs such as sedation and piloerection were observed in all animals following gavage, with recovery by Day 2. There were no macroscopic changes in the organs at necropsy. No mortality was recorded in either sex. Under the study conditions, the LD50 in rats was >5000 mg/kg bw (equivalent to >2400 to 2800 mg a.i./kg bw) (Skydsgaard, 1985).

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From February 20, 1996 to April 11, 1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
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: 152-174 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 (%): 39-65
- Air changes (per h): 15
- Photoperiod (h dark/h light): 12/12

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 1.99 mL/kg
Doses:
2000 mg/kg
No. of animals per sex per dose:
Five
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
Statistics:
None
Preliminary study:
No deaths or clinical signs of toxicity were observed
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality
Clinical signs:
No signs of systemic toxicity
Body weight:
All animals showed expected gain in body weight
Gross pathology:
No abnormalities noted at necropsy
Other findings:
None

None

Interpretation of results:
GHS criteria not met
Conclusions:
Under the study conditions, the LD50 in rats was >2000 mg/kg bw.
Executive summary:

A study was performed to assess the acute oral toxicity of the test substance, C8-18 and C18-unsatd. DEA, in Sprague-Dawley CD rats according to OECD Guideline 401 and EU Method B1, in compliance with GLP. A group of 10 fasted animals (five males and five females) was administered a single oral dose of test substance at a dose level of 2000 mg/kg bw. The animals were observed for 14 d after dosing, then sacrificed and subjected to gross pathological examination. No mortalities and no signs of systemic toxicity were observed during the study. All animals showed expected gain in body weight. No abnormalities were observed at necropsy. Under the study conditions, the LD50 in rats was >2000 mg/kg bw (Hempstock, 1996).


Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
Sufficient good quality data available.

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:
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:
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
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 available.
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:
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.
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 test 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
Quality of whole database:
Sufficient data available.

Additional information

Oral

A study was performed to assess the acute oral toxicity of the test substance, C8-18 and C18-unsatd. DEA, in Sprague-Dawley CD rats according to OECD Guideline 401 and EU Method B1, in compliance with GLP. A group of 10 fasted animals (five males and five females) was administered a single oral dose of test substance at a dose level of 2000 mg/kg bw. The animals were observed for 14 d after dosing, then sacrificed and subjected to gross pathological examination. No mortalities and no signs of systemic toxicity were observed during the study. All animals showed expected gain in body weight. No abnormalities were observed at necropsy. Under the study conditions, the LD50 in rats was >2000 mg/kg bw (Hempstock, 1996).

A study was performed to assess the acute oral toxicity of the test substance, C8-18 and C18-unsatd. DEA (48 - 56% active), in Wistar rats according to OECD Guideline 401. A group of 10 fasted animals (five males and five females) was given a single oral dose of test substance at a dose level of 5000 mg/kg bw. The animals were observed for 14 d after dosing, then sacrificed and subjected to gross pathological examination. Clinical signs such as sedation and piloerection were observed in all animals following gavage, with recovery by Day 2. There were no macroscopic changes in the organs at necropsy. No mortality was recorded in either sex. Under the study conditions, the LD50 in rats was >5000 mg/kg bw (equivalent to >2400 to 2800 mg a.i./kg bw) (Skydsgaard, 1985).

Dermal

A study was conducted to determine the acute dermal toxicity of the test 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 for the test substance indicates a low potential for acute toxicity (oral and dermal LD50s >2,000 mg/kg bw). The substance therefore does not meet the requirement for classification according to CLP (EC 1272/2008) criteria.