Reaction mass of 2,2',2''-nitrilotriethanol and 2,2'-[[2-[(2-hydroxyethyl)amino]ethyl]imino]bisethanol and 2,2'-iminodiethanol

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study performed according to guidelines and under GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

GLP compliance:

yes

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

A skin sensitisation study according to OECD 406 with adequate quality was already available, and therefore a further LLNA study was not needed to be developed.

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

In vivo test system

Test animals

Species:

guinea pig

Strain:

Dunkin-Hartley

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: David Hall Limited, Burton-on-Trent, Staffordshire, U.K.
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 310 - 396g
- Housing: housed singly or in pairs in solid-floor polypropylene cages furnished with woodflakes
- Diet (e.g. ad libitum): free access to mains tap water and food (Guinea Pig FDI Diet, Special Diets Services Limited, Witham, Essex, U.K.) was allowed throughout the study.
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20- 23
- Humidity (%): 56-67
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

intradermal and epicutaneous

Vehicle:

unchanged (no vehicle)

Induction 2

Concentration / amount:

Intradermal induction: i) Freund's Complete Adjuvant plus distilled water in the ratio 1:1, ii) 1% w/v dilution of test material in distilled water., iii) 1% w/v dilution of test material in a 1:1 preparation of Freund's Complete Adjuvant plus distilled water.
Epicutaneous induction: Undiluted material, 0.2 - 0.3 ml applied to filter paper
Challenge: 75% and 50 % v/v in distilled water.

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

unchanged (no vehicle)

Challenge 2

Concentration / amount:

Intradermal induction: i) Freund's Complete Adjuvant plus distilled water in the ratio 1:1, ii) 1% w/v dilution of test material in distilled water., iii) 1% w/v dilution of test material in a 1:1 preparation of Freund's Complete Adjuvant plus distilled water.
Epicutaneous induction: Undiluted material, 0.2 - 0.3 ml applied to filter paper
Challenge: 75% and 50 % v/v in distilled water.

No. of animals per dose:

10 animals+ 5 in control

Positive control substance(s):

no

Results and discussion

In vivo (non-LLNA)

Results

Results 1

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

1 %

No. with + reactions:

1

Total no. in group:

10

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1 %. No with. + reactions: 1.0. Total no. in groups: 10.0.

Results 2

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

1%

No. with + reactions:

0

Total no. in group:

10

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 10.0.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information

Conclusions:

Based on results from triethanolamine, the major constituent of the multiconstituent substance, it is concluded that the substance is a weak sensitiser, no labelling is required.