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Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP-guideline study, pre-test was only performed in in vitro skin models.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

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:
Available study from 1997

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
425-380-9
EC Name:
-
Cas Number:
7397-46-8
Molecular formula:
C5H13BO
IUPAC Name:
methyl diethylborinate
Details on test material:
- Name of test material (as cited in study report): DEMB
- Physical state: Water-white liquid
- Analytical purity: 99.4 %
- Lot/batch No.: 183
- Expiration date of the lot/batch: August 01, 1997
- Stability under test conditions: in the vehicle dry propylene glycol stable for 16-20 h
- Storage condition of test material: At room temperature in the dark
- Other: Density 0.76 g/ml

In vivo test system

Test animals

Species:
guinea pig
Strain:
Himalayan
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: BRL Ltd., Basel, Switzerland
- Age at study initiation: 7 weeks
- Weight at study initiation: Between 462-612 grams
- Housing: 5 animals/cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days before the start of treatment

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C
- Humidity (%): 50 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
propylene glycol
Concentration / amount:
Intradermal induction:
A) Freunds' Complete Adjuvant (Difco, Detroit, U.S.A.), 50:50 with water
B) The test substance at a 5% concentration
C) The test substance at a 5% concentration and Freunds' Complete Adjuvant separately very close together (0.05 ml each)

Percutaneous induction:
0.5 ml of a 20% test substance concentration

1. Challenge: 5 and 10 %
2. Challenge: 2 and 5 %
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
propylene glycol
Concentration / amount:
Intradermal induction:
A) Freunds' Complete Adjuvant (Difco, Detroit, U.S.A.), 50:50 with water
B) The test substance at a 5% concentration
C) The test substance at a 5% concentration and Freunds' Complete Adjuvant separately very close together (0.05 ml each)

Percutaneous induction:
0.5 ml of a 20% test substance concentration

1. Challenge: 5 and 10 %
2. Challenge: 2 and 5 %
No. of animals per dose:
control group: 5
experimental group 10
Details on study design:
RANGE FINDING TESTS: A preliminary study with non-living animal skin was performed

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: three pairs of intradermal injections on day 1 and percutaneous induction with 20 % test substance on day 8
- Control group: treated with vehicle
- Site: scapular region


B. CHALLENGE EXPOSURE
- No. of exposures: 2 challenges
- Day(s) of challenge: day 22 and 29
- Site: first flank, second flank
- Concentrations: 1. challenge 5 and 10 %; 2. challenge 2 and 5 %
- Evaluation (hr after challenge): treated sites were assessed for challenge reactions 24 and 48 hours after removal of the dressing.

Grading:

Grading challenge reactions:
0= No visible change
1= Discrete or patchy erythemae
2= Moderate and confluent erythemae
3= Moderete erythema and swelling
4= Intense erythemae and swelling
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
other: 1st challenge, 1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
5 %
No. with + reactions:
2
Total no. in group:
9
Remarks on result:
other: Reading: other: 1st challenge, 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5 %. No with. + reactions: 2.0. Total no. in groups: 9.0.
Reading:
other: 1st challenge, 2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
5 %
No. with + reactions:
4
Total no. in group:
9
Remarks on result:
other: Reading: other: 1st challenge, 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5 %. No with. + reactions: 4.0. Total no. in groups: 9.0.
Reading:
other: 1st challenge, 1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10 %
No. with + reactions:
6
Total no. in group:
9
Remarks on result:
other: Reading: other: 1st challenge, 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10 %. No with. + reactions: 6.0. Total no. in groups: 9.0.
Reading:
other: 1st challenge, 2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10 %
No. with + reactions:
5
Total no. in group:
9
Remarks on result:
other: Reading: other: 1st challenge, 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10 %. No with. + reactions: 5.0. Total no. in groups: 9.0.
Reading:
other: 2nd challenge, 1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
2 %
No. with + reactions:
2
Total no. in group:
9
Remarks on result:
other: Reading: other: 2nd challenge, 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 2 %. No with. + reactions: 2.0. Total no. in groups: 9.0.
Reading:
other: 2nd challenge, 2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
2 %
No. with + reactions:
1
Total no. in group:
9
Remarks on result:
other: Reading: other: 2nd challenge, 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 2 %. No with. + reactions: 1.0. Total no. in groups: 9.0.
Reading:
other: 2nd challenge, 1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
5 %
No. with + reactions:
4
Total no. in group:
9
Remarks on result:
other: Reading: other: 2nd challenge, 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5 %. No with. + reactions: 4.0. Total no. in groups: 9.0.
Reading:
other: 2nd challenge, 2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
5 %
No. with + reactions:
0
Total no. in group:
9
Remarks on result:
other: Reading: other: 2nd challenge, 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5 %. No with. + reactions: 0.0. Total no. in groups: 9.0.

Applicant's summary and conclusion

Executive summary:

According to Annex VI of the EU Regulation (EC) N0. 1272/2008 (CLP) and Annex I of the EU directive 67/548/EEC, DEMB is classified as sensitizing to the skin Cat 1 and R43, respectively.