2-(2-(2-methoxyethoxy)ethoxy)ethanol

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

Study period:

March 1990

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study is similar to OECD guideline regulatory studies, methods are well reported, but study is not GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Deviations:

not specified

GLP compliance:

no

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

An adequate in vivo GPMT study is already available

Test material

Test material information

Constituent 1

Reference substance name:

2-(2-(2-methoxyethoxy)ethoxy)ethanol

EC Number:

203-962-1

EC Name:

2-(2-(2-methoxyethoxy)ethoxy)ethanol

Cas Number:

112-35-6

Molecular formula:

C7H16O4

IUPAC Name:

2-[2-(2-methoxyethoxy)ethoxy]ethan-1-ol

Constituent 2

Reference substance name:

Tris[2-[2-(2-methoxyethoxy)ethoxy]ethyl] orthoborate

EC Number:

250-418-4

EC Name:

Tris[2-[2-(2-methoxyethoxy)ethoxy]ethyl] orthoborate

Cas Number:

30989-05-0

IUPAC Name:

tris{2-[2-(2-methoxyethoxy)ethoxy]ethyl} borate

Constituent 3

Reference substance name:

triethylene glycol monomethyl ether, borate

IUPAC Name:

triethylene glycol monomethyl ether, borate

Constituent 4

Reference substance name:

Tris(2,5,8,11-tetraoxatridecyl) orthoborate

EC Number:

260-535-2

EC Name:

Tris(2,5,8,11-tetraoxatridecyl) orthoborate

Cas Number:

57057-98-4

IUPAC Name:

tris(3,6,9,12-tetraoxatridec-1-yl) borate

Constituent 5

Reference substance name:

2,5,8,11,14-Pentaoxahexadecan-16-ol, triester with boric acid (H3BO3)

Cas Number:

75672-72-9

IUPAC Name:

2,5,8,11,14-Pentaoxahexadecan-16-ol, triester with boric acid (H3BO3)

Constituent 6

Reference substance name:

3,6,9,12-tetraoxotridecanol

EC Number:

245-883-5

EC Name:

3,6,9,12-tetraoxotridecanol

Cas Number:

23783-42-8

Molecular formula:

C9H20O5

IUPAC Name:

2,5,8,11-tetraoxatridecan-13-ol

Constituent 7

Reference substance name:

3,6,9,12,15-pentaoxahexadecanol

EC Number:

245-874-6

EC Name:

3,6,9,12,15-pentaoxahexadecanol

Cas Number:

23778-52-1

Molecular formula:

C11H24O6

IUPAC Name:

2,5,8,11,14-pentaoxahexadecan-16-ol

Details on test material:

Triethylene glycol monomethyl ether, borate (CAS No. 30989-05-0): 35-40%
Triethylene glycol monomethyl ether (CAS No. 112-35-6): 15-25%
Mixed ethylene glycol monomethyl ethers and corresponding borate esters: 33-48%

In vivo test system

Test animals

Species:

guinea pig

Strain:

Dunkin-Hartley

Sex:

male/female

Details on test animals and environmental conditions:

Animals, after acclimatisatino period, were housed 2-3/cage and provided food and water ad libitum. Room was maintained at 19-23C, with 30-70% relative humidity. Light was maintained on a 12-hour cycle.

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

intradermal and epicutaneous

Vehicle:

water

Induction 2

Concentration / amount:

0.6% in FCA (induction)
100% epicutaneous induction phase
60% in challenge

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

water

Challenge 2

Concentration / amount:

0.6% in FCA (induction)
100% epicutaneous induction phase
60% in challenge

No. of animals per dose:

10/sex for treated animals, 5/sex for the negative control

Details on study design:

Range finding test on 2 animals/sex was carried out to determine the maximum concentration for the intradermal induction. Animals were closely shorn in the shoulder region, and two rows of intradermal injections were made on either side of the midline. 0.1 mL of Freund's Complete Adjuvant, 0.1 mL of test material in vehicle, and 0.1 mL of test material in 50:50 FCA/vehicle.
One week after intradermal injections, the same region was again shorn, and 0.3 mL of undiluted test material was applied via moistened filter paper under occlusive bandage and held in place for 48 hours.
Three weeks after the induction phase, the one flank of each animal was shorn, and 0.1 mL of diluted test material applied via filter paper and held in place by occlusive bandage for 24 hours. Reactions were read 24 and 48 hours after patch removal, and graded on a 4 point scale.

Challenge controls:

Water was used as a negative 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:

0.1 mL 50% dilution

No. with + reactions:

0

Total no. in group:

20

Clinical observations:

None

Remarks on result:

no indication of skin sensitisation

Remarks:

Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1 mL 50% dilution. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: None.

Results 2

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

0.1 mL 50% dilution

No. with + reactions:

0

Total no. in group:

20

Clinical observations:

None

Remarks on result:

no indication of skin sensitisation

Remarks:

Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.1 mL 50% dilution. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: None.

Any other information on results incl. tables

A study using such a formulation is considered relevant to use for this substance since such formulations represent 95% of the end use of this substance.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information

Conclusions:

Brake FLuid DOT 4 Super is not sensitising

Executive summary:

Brake Fluid DOT 4 Super was tested for sensitisation in Guinea pigs using the Magnusson and Kligman assay. No evidence of sensitsation was observed, and the formulation was considered to be non-sensitising. The composition of the tested substance is primarily TEGME or its borated form (which rapidly hydrolyses in the presence of water) with higher homologues present as impurities.