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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:
weight of evidence
Study period:
1977
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted prior to GLP, but follows accepted guidelines and is well reported.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
no
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Composition (Chemical name,CAS No., and Percent Composition)
Contains:
Triethylene glycol monomethyl ether borate ester (30989-05-0) (30-50%);
Triethylene glycol monobutyl ether borate ester (3-30%);
Triethylene glycol monomethyl ether (112-35-6)(20-30%);
Triethylene glycol monobutyl ether (143-22-6)(2-10%);
Tetraethylene glycol monomethyl ether (23783-42-8) (20-30%),;
Tetraethylene glycol monobutyl ether (1559-34-8)(2-10%); minor additives (<1%).

Molecular Formula Mixture
CAS No. n/a
Physical form of marketed product Liquid
Melting point (oC) <51.7
Boiling point (oC) >260
Density (g/cm3) 1.06
Vapor pressure (hPa) < 0.01
Water solubility(mg/l ) Soluble
Flash point (oC) 121

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: P-strain
Sex:
male/female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
5% for induction phase 1, undiluted for induction phase 2, and 50% challenge phase
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
5% for induction phase 1, undiluted for induction phase 2, and 50% challenge phase
No. of animals per dose:
20 (test material); 10 (negative controls)
Details on study design:
Induction Phase:
Guinea pigs were shorn in the shoulder region and challenged in 2 rows of 3 intradermal injections each with 0.1 mL Freund's Complete Adjuvant, 5% Brake Fluid 500 DOT 4 in water, or 5% Brake Fluid 500 DOT 4 in 50:50 water: FCA. One week after the intradermal injections, the site was clipped free of hair and a soaked filter paper, covered with overlapping plastic adhesive tape and secured with an elastic bandage and left in place for 48 hours.

Challenge Phase:
Two weeks after topical induction, hair was removed from the site and test material was applied via soaked filter paper, covered with an adhesive tape, and held in place with an elastic bandage for 48 hours. Reactions were read at 24 and 48 hours.
Challenge controls:
Vehicle (water) was used as negative control
Positive control substance(s):
not required

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50%
No. with + reactions:
9
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50%. No with. + reactions: 9.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
50%
No. with + reactions:
0
Total no. in group:
19
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 19.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
50%
No. with + reactions:
0
Total no. in group:
19
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 19.0.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Brake Fluid 500 DOT 4 was non-sensitising to Guinea pig skin
Executive summary:

Brake Fluid 500 DOT 4 was tested for skin sensitisation using the Guinea pig Magnusson and Kligman method. No evidence of skin sensitisation was seen in the study.