Tall oil, compd. with triethanolamine

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1973

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Data appear solid, but report lacks details consistent with a guideline study.

Data source

Reference

Reference Type:

publication

Title:

Final Report on the Safety Assessment of Triethanolamine, Diethanolamine and Monoethanolamine.

Author:

Cosmetic Ingredient Review (CIR)

Year:

1983

Bibliographic source:

J. Am. Coll. Toxicol. 2 (7): 173-235.

Materials and methods

Principles of method if other than guideline:

Not specified.

GLP compliance:

no

Type of study:

not specified

Justification for non-LLNA method:

An existing in vivo study already existed. Therefore, it was considered un-ethical to re-run the study according to the LLNA method

Test material

Test material information

Constituent 1

Reference substance name:

2,2',2''-nitrilotriethanol

EC Number:

203-049-8

EC Name:

2,2',2''-nitrilotriethanol

Cas Number:

102-71-6

Molecular formula:

C6H15NO3

IUPAC Name:

2,2',2''-nitrilotriethanol

Test material form:

not specified

Specific details on test material used for the study:

Identity: Triethanolamine
CAS Number: 102-71-6
Purity: 5-100% triethanolamine

In vivo test system

Test animals

Species:

guinea pig

Strain:

not specified

Sex:

not specified

Details on test animals and environmental conditions:

Number of animals/sex/dose: Not specified.

Results and discussion

In vivo (non-LLNA)

Results

Results 1

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

100%

No. with + reactions:

0

Total no. in group:

20

Remarks on result:

no indication of skin sensitisation

Results 2

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

100%

No. with + reactions:

0

Total no. in group:

20

Remarks on result:

no indication of skin sensitisation

Results 3

Group:

positive control

Remarks on result:

not measured/tested

Results 4

Group:

negative control

Remarks on result:

not measured/tested

Any other information on results incl. tables

1) One erythemic reaction occured in each of three animals during the induction procedure, in two other animals during the first challenge, and in one other animal during the second challenge. All the guinea pigs remained healthy and made normal weight gains during the test. There was no evidence of any skin sensitizing activity of undiluted TEA for guinea pigs(a).

2) None of the animals showed clinical symptoms during or after the treatment period and no guinea pigs showed signs of primary irritation of the skin. Challenge reactions were measured with a reflectometer and average readings between control and experimental animals were compared. TEA was not a guinea pig skin sensitizer in these studies (b,d,e).

3) No irritation was observed. No positive primary irritation or sensitization responses were observed under the test conditions with the 25 percent active TEA solution(f).

(a)LIFE SCIENCE RESEARCH. (Jan. 3, 1975). Submission of data by CTFA. (2-5-50). Dermal sensitization test in guinea-pigs (TEA).

(b)INTERNATIONAL BIO-RESEARCH (IBR). (1975). Submission of data by CTFA. (2-5-51). Triethanolamine ex Naphtachimie, delayed contact hypersensitivity in guinea pigs.

(c)INTERNATIONAL BIO-RESEARCH (IBR). (1975). Submission of data by CTFA. (2-5-52). Triethanolamine ex Hula, delayed contact hypersensitivity in guinea pigs.

(d)IBR. (1975). Submission of data by CTFA. (2-5-53). Triethanolamine ex Shell, delayed contact hypersensitivity in guinea pigs.

(e)IBR. (1975). Submission of data by CTFA. (2-5-54). Triethanolamine ex B.A.S.F., delayed contact hypersensitivity in guinea pigs.

(f)HILL TOP RESEARCH (HTR). (June 20, 1973). Submission of data by CTFA. (2-5-49). Delayed hypersensitivity studies in guinea pigs of (TEA) (25 percent active).

Applicant's summary and conclusion

Conclusions:

TEA was not a guinea pig skin sensitizer in these studies.

Executive summary:

1: Pairs of guinea pigs were treated dermally with 5%-100% TEA in water for 6 h with occlusion, treated sites were scored for erythema at 24 and 48 h. Since use of undiluted TEA resulted in only one erythemic reaction at 24 h, 100% TEA was used in both induction and challenge procedures in the subsequent sensitization test. Twenty guinea pigs received dermal applications of undiluted TEA once per week for three weeks. A challenge patch was applied after 14 days and again seven days later. There was no evidence of any skin sensitizing activity of undiluted TEA for guinea pigs.

2: TEA from four different suppliers was evaluated in guinea pig skin sensitization tests. The tests were conducted with 10 control and 20 treated guinea pigs. The induction patches were applied once a week for up to six hours for three weeks. Two weeks later challenge patches were applied to both control and treated guinea pigs. One test was conducted with undiluted TEA at induction and 90% TEA at challenge and all the other tests were conducted with 50% TEA at induction and 90% TEA at challenge. TEA was not a guinea pig skin sensitizer in these studies.

3: Patches containing a 25% active TEA solution and 10% and 5% TEA in aqueous solution were applied to the backs of four clipped guinea pigs. No irritation was observed in this preliminary study. Induction patches containing the 25% TEA solution were applied to the backs of 20 clipped guinea pigs for 6 h once per week for three weeks. One week later, a challenge patch containing 25% TEA was applied for 6 h to the clipped backs of the 20 treated and 10 control guinea pigs. Challenge reactions were read at 24 h and at 48 h. No positive primary irritation or sensitization responses were observed under the test conditions with the 25% active TEA.

Triethanolamine (TEA) was not a Guinea-Pig Sensitiser