Octanoic acid, ester with 1,2,3-propanetriol

Endpoint summary

Description of key information

The acute oral median lethal dose (LD50) of the test material, octanoic acid, ester with 1,2,3 -propanetriol, to the rat was found to be greater than 2000 mg/kg bodyweight.

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, 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

Study period:

March 12th - March 26th, 1987

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

Purity of test substance not given.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Specific details on test material used for the study:

Imwitor 908

Species:

rat

Strain:

other: Sprague-Dawley CFY strain

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Interfauna Ltd., Cambridgeshire, U.K.
- Age at study initiation: 5-8 weeks
- Weight at study initiation: males 104-122 g; females 100-108 g.
- Fasting period before study: yes
- Housing: goups of up to five in solid-floor polypropylene cages with sawdust bedding
- Diet (e.g. ad libitum): Rat and Mouse Expanded Diet No. 1, Special Diet Services Ltd., Essex, U.K.
- Water (e.g. ad libitum): yes
- Acclimation period: min 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22
- Humidity (%): 45 - 52
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VOLUME APPLIED: 2.03 mL/kg bw
spec. gravitiy 0.988

Doses:

2000 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: Animals were observed 1 and 4 h after dosing and subsequently once daily for 14 days
- Necropsy of survivors performed: yes, all animals were subjected to gross necropsy
- Other examinations performed: body weights were recorded on days 0, 7 and 14

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: rat

Mortality:

No deaths occured during the study period.

Clinical signs:

No evidence of systemic toxicity were noted during the study period.

Body weight:

All animals showed normal gains in bodyweight during the study period.

Gross pathology:

No abnormalities occured.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Executive summary:

The acute oral median lethal dose (LD50) of the test material, IMWITOR 908, to the rat was found to be greater than 2000 mg/kg bodyweight.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via inhalation route

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:

read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Justification for type of information:

REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information are included as attachment to the same record, see links in 'Cross-reference' table

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
[Describe why the read-across can be performed (e.g. common functional group(s), common precursor(s)/breakdown product(s) or common mechanism(s) of action]

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Interpretation of results:

GHS criteria not met

Executive summary:

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.

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.