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Description of key information

All available acute toxicity studies within this Category showed that Fatty Acid Glycerides are non-toxic via the oral or dermal exposure route. 
Studies on acute oral toxicity were available for the following members of this category (CAS No.):
26402-26-6, 31566-31-1, 73398-61-5 and medium and long chain triglycerols (MLCT).
The acute oral LD50 for rats and mice in all studies was found to be greater than 2000 or 5000 mg/kg bw.
Studies on acute dermal toxicity were available for the following members of this category (CAS No.):
91845-19-1, 555-43-1, 620-67-7, 91052-13-0.
The acute dermal LD50 in rats in all studies was found to be greater than 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:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study performed according to internationally accepted testing guideline, well documented.
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
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: Bantin & Kingman Ltd., Grimston, Aldborough, Hull, U.K.
- Age at study initiation: approx. five to eight weeks
- Weight at study initiation: 128-150 g (females), 137-147 g (males)
- Fasting period before study: overnight before dosing and for approximately two hours after dosing
- Housing: in groups of up to five by sex in solid-floor polypropylene cages with sawdust bedding
- Diet: Rat and Mouse Expanded Diet No. I, Special Diet Services Limited, Witham, Essex, U.K.) ad libitum
- Water: drinking water ad libitum
- Acclimation period: five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 21
- Humidity (%): 40 - 65
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Route of administration:
oral: gavage
Vehicle:
arachis oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: test material was freshly prepared as a suspension at the appropriate concentration in arachis oil B.P. The preparation was warmed to aid solubilisation.

MAXIMUM DOSE VOLUME APPLIED: 5000 mg/kg bw
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: recording of mortalities and observation of overt toxicity: 1 and 4 hours after dosing and then once daily for 14 days; recording of body weights on days 0, 7 and 14.
- Necropsy of survivors performed: gross necropsy and macroscopic examination on day 14 on all animals, no tissues were retained.
Statistics:
not performed
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
0
Clinical signs:
No overt signs of toxicity were noted during the study.
Body weight:
All animals showed expected gains in bodyweight over the study period.
Gross pathology:
No abnormalities were noted at necropsy of animals killed at the end of
the study.
Other findings:
Not mentioned

Table 1: Number of animals dead and with evident toxicity

 

Dose
(mg/kg bw)

Mortality (# dead/total)

Time range of deaths (hours)

Number with evident toxicity(#/total)

Male

Female

Combined

Male

Female

Combined

5000

 0

 0

 

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Executive summary:

The acute oral median lethal dose (LD50) of the test material, octanoic acid, monoester with glycerol, to the Sprague-Dawley CFY stain rat was found to be greater than 5000 mg/kg bodyweight.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion
Value:
mg/m³

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Study period:
22 Mar - 07 Apr 1993
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP - Guideline study. According to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
adopted in 1987
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
other: Bor: WISW
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Weight at study initiation: 250-260 g (males), 209-238 g (females)
- Housing: up to 5 animals per cage in Makrolon type III
- Diet: Ssniff R 10 - Complete feed for rats (Ssniff, Spezialfutter GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsum
- % coverage: 10%
- Type of wrap if used: gauze and acrylastic bandage

REMOVAL OF TEST SUBSTANCE
- Washing: residual test material was removed with warm water and gauze
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount applied: 2.08 cm³/kg bw
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: several times on Day 0, thereafter daily
- Frequency of weighing: Days 0, 7 and 14
- Necropsy of survivors performed: yes
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study period.
Clinical signs:
No signs of systemic toxicity observed.
Body weight:
All animals showed the expected gain in body weight.
Gross pathology:
Necropsy revealed no substance-related findings.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
Guideline studies or similar well documented.

Additional information

Acute oral toxicity:

All available acute oral toxicity studies confirmed that Fatty Acid Glycerides are non-toxic.

In an acute oral toxicity study (limit test) in Spraque-Dawley rats the acute oral LD50 for glyceryl caprylate (26402 -26 -6) was found to be greater than 2000 mg/kg bw.

In an acute oral toxicity study (limit test) in Wistar rats the acute oral LD50 for medium and long chain triglycerides was found to be greater than 5000 mg/kg bw (MLCT).

In an acute oral toxicity study (limit test) in Wistar rats the acute oral LD50 for Triglycerides, mixed decanoyl and octanoyl (CAS No. 73398 -61-5) was found to be greater than 5000 mg/kg bw.

In an acute oral toxicity study (limit test) in Tyler's Original Strain mice the acute oral LD50 for Triglycerides, mixed decanoyl and octanoyl (CAS No. 73398 -61 -5) was found to be greater than 5000 mg/kg bw.

 

Acute dermal toxicity:

All available acute dermal toxicity studies confirmed that Fatty Acid Glycerides are non-toxic.

In an acute dermal toxicity study (limit test) in Wistar rats the acute dermal LD50 for Glycerides, C16-18 and C18-hydroxy mono- and di- (CAS No. 91845-19-1) was found to be greater than 2000 mg/kg bw.

In an acute dermal toxicity study (limit test) in Wistar rats the acute dermal LD50 for Glycerol Tristearate (CAS No. 555 -43 -1) was found to be greater than 2000 mg/kg bw.

In an acute dermal toxicity study (limit test) in rats the acute dermal LD50 for propane-1,2,3-triyl trisheptanoate (CAS No. 620-67-7) was found to be greater than 2000 mg/kg bw.

In an acute dermal toxicity study (limit test) in rats the acute dermal LD50 for Glycerides, C8-18 and C18-unsatd. mono- and di-, acetates (CAS No. 91052 -13-0) was found to be greater than 2000 mg/kg bw.

 


Justification for selection of acute toxicity – oral endpoint
The acute oral LD50 for rats and mice in all studies was found to be greater than 2000 or 5000 mg/kg bw.

Justification for selection of acute toxicity – dermal endpoint
The acute dermal LD50 in rats in all studies was found to be greater than 2000 mg/kg bw.

Justification for classification or non-classification

According to Article 13 of Regulation (EC) No. 1907/2006 "General Requirements for Generation of Information on Intrinsic Properties of substances", information on intrinsic properties of substances may be generated by means other than tests e.g. from information from structurally related substances (grouping or read-across), provided that conditions set out in Annex XI are met. Annex XI, "General rules for adaptation of this standard testing regime set out in Annexes VII to X” states that “substances whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or ‘category’ of substances. This avoids the need to test every substance for every endpoint". Since the group concept is applied to the members of the Glycerides category, data will be generated from data for reference source substance(s) to avoid unnecessary animal testing. Additionally, once the group concept is applied, substances will be classified and labelled on this basis.

Therefore, based on the group concept, the available data on acute toxicity do not meet the classification criteria according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.

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