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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1986-05-06 to 1986-07-10
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study performed according to guideline OECD 406

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Chemical structure
Reference substance name:
3-chloropropane-1,2-diol
EC Number:
202-492-4
EC Name:
3-chloropropane-1,2-diol
Cas Number:
96-24-2
Molecular formula:
C3H7ClO2
IUPAC Name:
3-chloropropane-1,2-diol
Details on test material:
- Name of test material (as cited in study report): Glycerin-Alpha-Monochlorhydrin
- Physical state: liquid
- Analytical purity: > 98%
- Lot/batch No.: 8630 M 5/6
- Stability under test conditions: Stable

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Himalayan White spotted
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Institut of Biomedical Research, CH 4414 Fuellinsdorf, Switzerland
- Age at study initiation: 8-9 weeks
- Weight at study initiation: 419-573g (males) and 428-547g (females)
- Housing: Individually in Makrolon type-3 cages with standard softwood bedding (Lignocel, Schill AG, 4132 Muttenz, Switzerland). Cages were twice weekly cleaned
- Diet: Pelleted standard Kliba 342, Batch 25/86 guinea pig breeding/maintenance diet (Kliba, Klingentalmuehle AG, 4303 Kaiseraugst, Switzerland) ad libitum.
- Water: Community tap water from Itingen, ad libitum
- Acclimation period: One week under test conditions after veterinary examination

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 40-70%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12:12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
physiological saline
Concentration / amount:
5% (intradermal, induction) and 100% (topical, induction and challenge)
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
physiological saline
Concentration / amount:
5% (intradermal, induction) and 100% (topical, induction and challenge)
No. of animals per dose:
10 males + 10 females for treatment and 5 males + 5 females for control
Details on study design:
RANGE FINDING TESTS: Intradermal injections (0.1 ml/site) were made into the clipped flank of two guinea pigs at concentrations of 5, 3, 1 and 0.5% of the test article in pysiological saline. the resulting dermal reactions were assessed 24 hrs later. Additionally patches of filter paper (2x2 cm) were saturated with concentrations of 100, 70, 50 and 25% of test article in physiological saline and applied to the clipped and shaved flank of four guinea pigs. The dressings were removed after an exposure period of 24 hours and the reaction sites were assessed for erythema and edema.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal + topical)
- Exposure period: 48 hrs (topical)
- Test groups: Test article in physiological saline (intradermal) and pure test article (topical)
- Control group: Physiological saline only
- Site: Scapular region
- Frequency of applications: weekly (d0 = intradermal and day7 = topical)
- Duration: 9 days
- Concentrations: 5% (intradermal) and 100% (topical)

B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: 21 & 35
- Exposure period: 24 hours
- Test groups: Test article
- Control group: Physiological saline only (first challenge) and Test article (re-challenge)
- Site: Left flank (challenge) and right flank (re-challenge)
- Concentrations: 100%
- Evaluation (hr after challenge): 24 and 48
Challenge controls:
Two challenges were performed each using 5 males + 5 females. In the first challenge physiological saline only was administered topically. In the second challenge control animals were treated with the test article in the same concentration as the animals of the test group (i.e. 100%) in order to avoid false positive results.
Positive control substance(s):
yes
Remarks:
DNCB, i.e. 1-chloro-2,4-dinitrobenzol

Study design: in vivo (LLNA)

Statistics:
Fisher-Test

Results and discussion

Positive control results:
After epidermal challenge application, DNCB showed positive responses in Dunkin Hartley albino guinea pigs: after 24 hours 9 (out of 15) guinea pigs were positive.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100%
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: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100%
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: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.

Any other information on results incl. tables

No positive reactions were evident after the first and second challenge application in the negative control group.

Local symptoms were similar between control and treated animals. Body weight gain was not affected.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
With the procedures used in this experiment, no differences between the test group and the vehicle-treated controls were evident after epidermal challenge application. Glycerin-alpha-monochlorhydrin is considered to possess no skin sensitizing (contact allergenic) potential.