Butane-2,3-diol

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD guideline study conducted in accordance with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of study:

guinea pig maximisation test

Test material

Test material information

Constituent 1

Reference substance name:

Butane-2,3-diol

EC Number:

208-173-6

EC Name:

Butane-2,3-diol

Cas Number:

513-85-9

Molecular formula:

C4H10O2

IUPAC Name:

butane-2,3-diol

In vivo test system

Test animals

Species:

guinea pig

Sex:

female

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

intradermal

Vehicle:

water

Induction 2

Concentration / amount:

test substance in 25% doubly distilled water

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

water

Challenge 2

Concentration / amount:

test substance in 25% doubly distilled water

No. of animals per dose:

10

Positive control substance(s):

yes

Remarks:

Alpha-Hexylcinnamaldehyde

Results and discussion

In vivo (non-LLNA)

Results

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

25% test substance preparation

No. with + reactions:

0

Total no. in group:

10

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25% test substance preparation. 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 the evaluation criteria cited under 3.6. the results of this study show that 2.3-Butandiol does not have a sensitizing effect on the skin of the guinea pig in the Maximization Test under the test conditions chosen.

Executive summary:

After the intradermal induction intense erythema and swelling were observed at the injection sites of all control group animals and all test group animals at which only Freund's adjuvant/0.9% aqueous NaCI-solution was applied. At the injection sites of a 5% test substance preparation in Freund's adjuvant/0.9% aqueous NaCI-solution intense erythema and swelling were seen in all test group animals. Injections of a 5% test substance preparation in 0.9% aqueous NaCI-solution caused moderate and confluent erythema and swelling in all test group animals. The control group animals, injected with 0.9% aqueous NaCI-solution did not show any skin reaction. A 50% formulation of 0.9% aqueous NaCI-solution with Freund's adjuvant/0.9% aqueous NaCI-solution caused intense erythema and swelling in all control group animals. The epicutaneous induction with a 50% test substance preparation in doubly distilled water led to incrustation, partially open (caused by the intradermal induction) and moderate and confluent erythema with swelling in all test group animals.

The challenge with a 25% test substance preparation in doubly distilled water did not cause any skin reactions neither in control group 1 nor in the test group 24 and 48 hours after removal of the patches. Since no borderline results were observed, a 2nd challenge was not performed. Control group 2, that had been intended for a potential 2nd challenge was not applied and therefore not reported.