Octanoic acid, compound with 2,2',2''-nitrilotriethanol (1:1)

Endpoint summary

Description of key information

Acute toxicity studies for the substance, Octanoic acid, compound with 2,2',2''-nitrilotriethanol (1:1) have not been conducted as per Annex VII, as this substance is classified as corrosive to skin.

However, literature data is available for 2,2',2''-nitrilotriethanol, which is reacted with Octanoic acid to form Octanoic acid, compound with 2,2',2''-nitrilotriethanol (1:1), within the cosmetic ingredient review safety assessment, which shows that this substance is not classified as acutely toxic according to the GHS criteria. This report concluded that TEA and various TEA containing ingredients are safe for use in cosmetics and therefore the TEA salt, Octanoic acid, compound with 2,2',2''-nitrilotriethanol (1:1) would also be expected to be non-toxic.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: oral

Type of information:

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

Adequacy of study:

supporting study

Study period:

1940 - 1951

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Justification for type of information:

Data from Cosmetic Ingredient Review published report.

Qualifier:

no guideline followed

Principles of method if other than guideline:

Collection of historial acute oral toxicity test results published in the Chemical Ingredient Review - Final Report on the Safety Assessment of TEA, DEA and MEA.

GLP compliance:

not specified

Specific details on test material used for the study:

Publication states that Triethanolamine of commercial or high purity grade was used in these studies.

Species:

rat

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

The animals were adminstered the material by gavage, and then were observed for 14 days.

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

The animals were adminstered the material by gavage, the LD50 values for 100% Commerical Grade TEA recorded in table 4 of the Safety Assessment are estimated from single feedings.

Doses:

Various dose levels are recorded in the Acute Oral Toxicity table (Table 4) of the CIR Safety Report. Dose levels reported for 100% Commercial grade TEA in this report are 1.0 - 26.0 g/Kg.

No. of animals per sex per dose:

10 rats; sex is not specified.

Details on study design:

Details on study design for tests conducted with Commericial grade and high purity grade TEA can be found in Kindsvatter, V.H. (1940). Acute and chronic toxicity of triethanolamine. J. Indust. Hyg. Toxicol. 22, 206-212. Details on the study design for Acute oral toxicity study conducted with TEA in water can be found in Smyth, H.F., Jr., Carpenter, C.P., and Weil, C.S. (1951). Range-finding toxicity data: List IV. AMA Arch. Ind. Hyg. Occup. Med. 4, 119-122. In these studies, rats and guinea pigs were administered Triethanolamine by gavage (1-26 g/Kg) and observed for 14 days. The LD50 values were estimated from this single feeding.

Sex:

not specified

Effect level:

ca. 8 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: TEA, Commercial grade (100%)

Sex:

not specified

Dose descriptor:

LD50

Effect level:

ca. 9 000 mg/kg bw

Remarks on result:

other: TEA, high purity grade (100%)

Sex:

not specified

Dose descriptor:

LD50

Effect level:

ca. 4 190 mg/kg bw

Based on:

other: 25% in water

Remarks on result:

other: Mixture of TEA 78.6%, DEA 8.6% and MEA 1.7%

Clinical signs:

other: Before death, diarrhoea and prostration was observed in most animals. Gross lesions in the animals that died were confined to the gastrointestinal tract and included gastric dilatation, congestion, and focal hemorrhage in the stomach and dilatation of int

Gross pathology:

Gross pathology was confined to the intestinal tract.

Other findings:

Kindsvatter (1940) suggested that the acute toxicity of triethanolamine was related to its alkalinity, based on the survival of one guinea pig fed 10 g/kg neutralized with hydrochloric acid; this dose exceeds the oral LD50 (8 g/kg) of triethanolamine when administered as the free base.

Interpretation of results:

GHS criteria not met

Conclusions:

In this publication, the acute oral LD50 values for Triethanolamine are reported as a range from 4.19 g/kg to 11.26 g/kg, this substance is therefore not classified according to GHS criteria.

Executive summary:

The acute oral toxicity of Triethanolamine was assessed in the cosmetic ingredient review publication, ‘Final Report on the Safety Assessment of Triethanolamine, Diethanolamine and Monoethanolamine’ (Journal of the American College of Toxicology, 2(7), pg 183–235, (1983)). The results of multiple in vivo acute oral toxicity studies are presented, where acute oral LD50 values range from 4.19 g/kg to 11.26 g/kg. As the results of the acute oral toxicity studies reported did not meet the criteria for classification, it was concluded in this safety assessment that Triethanolamine is practically nontoxic.

Reference 2

Endpoint:

acute toxicity: oral

Data waiving:

study technically not feasible

Justification for data waiving:

the study does not need to be conducted because the substance is classified as corrosive to the skin

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Acute toxicity studies for the substance, Octanoic acid, compound with 2,2',2''-nitrilotriethanol (1:1) have not been conducted as per Annex VII, as this substance is classified as corrosive to skin.