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Toxicological information

Skin sensitisation

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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. Rationale for using a read across substance is included in overall remarks section.

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:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
not specified
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Reliable in vivo GPMT study already available.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
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)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
0.6% in FCA (induction)
100% epicutaneous induction phase
60% in challenge
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
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

Study design: in vivo (LLNA)

Concentration:
not applicable
No. of animals per dose:
not applicable
Details on study design:
not applicable
Statistics:
not applicable

Results and discussion

Positive control results:
not applicable

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
0.1 mL 50% dilution
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
None
Remarks on result:
other: 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.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
0.1 mL 50% dilution
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
None
Remarks on result:
other: 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.

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, a mixture primarily of borated and non borated 2 -(2 -(2 -methoxyethoxy)ethoxy)ethanol, 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.