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

Acute Toxicity: oral

Administrative data

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.

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Final report on the safety assessment of triethanolamine, diethanolamine and monoethanolamine.

Author:

Elder, RE.

Year:

1983

Bibliographic source:

J Am Coll Toxicol. 1983; 2(7):183-235.

Reference 2

Reference Type:

publication

Title:

Acute and chronic toxicity of triethanolamine.

Author:

Kindsvatter, V.H.

Year:

1940

Bibliographic source:

J. Indust. Hyg. Toxicol. 22, 206-212.

Reference 3

Reference Type:

publication

Title:

Range-finding toxicity data: List IV.

Author:

Smyth, H.F., Jr., Carpenter, C.P., and Weil, C.S.

Year:

1951

Bibliographic source:

AMA Arch. Ind. Hyg. Occup. Med. 4, 119-122.

Reference 4

Reference Type:

publication

Title:

Safety assessment of triethanolamine and triethanolamine-containing ingredients as used in cosmetics.

Author:

Flume et al

Year:

2013

Bibliographic source:

Int J Toxicol. 2013 May-Jun;32(3 Suppl):59S-83S

Materials and methods

Test guideline

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

Test material

Specific details on test material used for the study:

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

Test animals

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.

Administration / exposure

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.

Results and discussion

Effect levels

Effect levels 1

Sex:

not specified

Effect level:

ca. 8 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: TEA, Commercial grade (100%)

Effect levels 2

Sex:

not specified

Dose descriptor:

LD50

Effect level:

ca. 9 000 mg/kg bw

Remarks on result:

other: TEA, high purity grade (100%)

Effect levels 3

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.

Applicant's summary and conclusion

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.