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Description of key information

Based on the results of the read across study, test substance, 'di-C16-18-satd. and C18-24-unsatd. AAEMIM-MS' is considered to be of low acute oral toxicity, with an oral LD50 value >2000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
From October 03, 2007 to October 10, 2007
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
KL2 due to RA
Justification for type of information:
Refer to section 13 of IUCLID 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 source
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
other: HanRcc: WIST(SPF)
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 11 weeks
- Weight at study initiation: 165.1 - 186.2 9 at day of application
- Fasting period before study: for approximately 17 to 18 h (access to water was permitted). Food was provided again approximately 3 h after dosing
- Housing: In groups of three in Makrolon type-4 cages with wire mesh tops and standard softwood bedding ('Lignocel' Schill AG, CH-4132 Muttenz/Switzerland)
- Diet: ad libitum; pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet, batch no. 23/07 (Provimi Kliba AG, CH-4303 Kaiseraugst/Switzerland)
- Water: ad libitum; community tap water from Füllinsdorf
- Acclimation period: 6 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 3°C
- Humidity (%): 30 -70 %
- Air changes (per hr): 10-15 air changes per h
- Photoperiod (hrs dark / hrs light): the Iightening was in a 12-h Iight/dark-cycle.
Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
Maximum dose volume applied: 2000 mg/kg body weight
Doses:
Dose levels: 2000 mg/kg body weight
Concentrations: 0.2 g/mL
Dosing: one single application by gavage
Dosing volume: 10 mL/kg bw
The test substance was weighed into a tared glass beaker on a suitable precision balance and the vehicle added (weight:volume).
Afterwards, the test substance preparation was warmed up to 50°C. The formulations were prepared using a suitable homogenizer. The test substance preparation was kept at room temperature for cooling and was administered when a temperature between 20°C and 30°C is reached. The temperature was measured before treatment with a thermometer and reached 24°C and 25.8°C.
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
All animals were killed at the end of the observation period by carbon dioxide asphyxiation and discarded after macroscopic examinations were performed. No organs or tissues were retained.
- Frequency of observations and weighing:

- Mortality / Viability and Clinical Signs: Daily during the acclimatization period, during the first 30 minutes and at approximately 1, 2, 3 and 5 hours after administration on test day 1 and twice daily during days 2-15. All abnormalities were recorded.

- Body Weights: On test days 1 (prior to administration), 8 and 15.
Statistics:
No statistical analysis was used.
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
act. ingr.
Remarks:
No animal died
Remarks on result:
other: No animal died
Mortality:
No deaths occurred during the study.
Clinical signs:
No clinical signs were observed during the course of the study.
Body weight:
The body weight of the animals was within the range commonly recorded for this strain and age.
Gross pathology:
No macroscopic findings were recorded at necropsy.
Interpretation of results:
other: CLP criteria not met
Conclusions:
Based on the results of the read across study, similar oral LD50 value can be expected for the test substance.
Executive summary:

A study was conducted to determine the acute oral toxicity of the read substance, 'di-C16-18 and C18-unsatd. AAEMIM-MS', according to OECD Guideline 423 (Acute Toxic Class Method), in compliance with GLP. Three FemaleHanRcc: WIST(SPF)rats were administered the test substance by oral gavage at a dose of 2000 mg/kg bw. Following administration, the animals were observed for 14 d and mortality, clinical signs and body weights were recorded daily. At the end of this period, rats were examined for macroscopic and microscopic abnormalities. There was no mortality in this study. No evidence of systemic toxicity was noted during the study period. No toxicologically significant effects on bodyweight were recorded during the study period and no abnormalities were seen at necropsy of animals killed at the end of the study. Under the study conditions, the acute oral LD50 of the substance in rats was determined to be >2000 mg/kg bw (Arcelin, 2010). Based on the results of the read across study, similar oral LD50 value can be expected for the test substance, ' di-C16-18-satd. and C18-24-unsatd. AAEMIM-MS'.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
Good quality Guideline compliant study.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

A study was conducted to determine the acute oral toxicity of the read across substance, 'di-C16-18 and C18-unsatd. AAEMIM-MS', according to OECD Guideline 423 (Acute Toxic Class Method), in compliance with GLP. Three FemaleHanRcc: WIST(SPF)rats were administered the test substance by oral gavage at a dose of 2000 mg/kg bw. Following administration, the animals were observed for 14 d and mortality, clinical signs and body weights were recorded daily. At the end of this period, rats were examined for macroscopic and microscopic abnormalities. There was no mortality in this study. No evidence of systemic toxicity was noted during the study period. No toxicologically significant effects on bodyweight were recorded during the study period and no abnormalities were seen at necropsy of animals killed at the end of the study. Under the study conditions, the acute oral LD50 of the substance in rats was determined to be >2000 mg/kg bw (Arcelin, 2010). Based on the results of the read across study, similar oral LD50 value can be expected for the test substance, ' di-C16-18-satd. and C18-24-unsatd. AAEMIM-MS'.

Justification for classification or non-classification

Based on the results of the read across study, the test substance, 'di-C16-18-satd. and C18-24-unsatd. AAEMIM-MS', does not warrant classification for acute oral toxicity, according to the EU CLP criteria (Regulation 1272/2008/EC).