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Diss Factsheets

Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
other information
Study period:
22 November 1988 to 23 December 1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study conducted to an appropriate test guideline with no or minor deviations.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

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:
The LLNA method was not available yet by the time the study was conducted

Test material

Constituent 1
Reference substance name:
cis-1,3-dichloropropene
IUPAC Name:
cis-1,3-dichloropropene
Details on test material:
From Appendix A:
Batch an other numbers SNC No. 1986: 88009
Toxicology reference No. St88/253Source: Shell Nederland Raffindarerij BV Rotterdam
Date received: 18 Oct 1988
Appearance: clear colourless liquid
Analysis: 94.51-97.51% cis isomer with 1.5% trans isomer
Density: 1.224 g/mL @ 15.2 ºC
Date released: 18 Nov 1988
Storage: dark at ambient temperature
Stability: stable for the duration of the study (no changes from 21 Nov 1988 to 19 Jan 1989

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
not specified
Details on test animals and environmental conditions:
Guinea-pigs (Dunkin-Hartley strain) were obtained from Porcellus Ltd. Their bodyweight was between 300 and 400 g and their age 5 to 9 weeks at the time of receipt. The animals were housed initially in single sex groups of ten animals. After an acclimatisation period of at least two weeks they were re-allocated to cages accommodating two or three animals. Hanging stainless steel cages with wire-mesh floors were used, each measuring 54 cm x 31 cm x 36 cm, Sawdust-filled trays for excreta were placed beneath each cage and changed three times weekly. Pelleted diet (SG1 with vitamin C supplement, Grain Harvesters Ltd.) and water from the public supply were provided ad libitum. There were no excursions of animal room environmental conditions beyond target values of 19 to 23 °C and 30% to 70% R.H. that were considered to have influenced the outcome of the study. Lighting (fluorescent tube) was automatically controlled to provide a 12 hour day and 12 hour night. Animals assigned to the study were identified by cage-labels displaying animal numbers, experiment number, sex and treatment regime and, within the cage, by coloured dye-marking of the fur.

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
corn oil
Remarks:
and/or freund's complete adjuvant
Concentration / amount:
Intradermal induction: 0.1% (m/v)in corn oil/FCA
Topical induction: 5% (m/v) in corn oil
Topical challenge: 2.5% (m/v) in corn oil
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Remarks:
and/or freund's complete adjuvant
Concentration / amount:
Intradermal induction: 0.1% (m/v)in corn oil/FCA
Topical induction: 5% (m/v) in corn oil
Topical challenge: 2.5% (m/v) in corn oil
No. of animals per dose:
10/sex/dose (5/sex negative controls)
Details on study design:
Induction: 2 rows of intradermal injectiosn were made one on either side of the midline as follows (controls received solvents only):
0.1 mL FCA
0.1 mL 0.1% cis-1,3-DCP in FCA
0.1 mL 0.1% cis-1,3-DCP in 50:50 FCA/corn oil
One week after intradermal injection, the same area of skin was shaven and a 16cm2 patch includin 0.3 mL of 5% test material in corn oil was applied occlusively for 48 hr with negative controls with vehicle only.
Challenge:
3 weeks after intradermal induction, hair was shaved and a 4cm2 patch containing 0.1mL of 2.5% cis-1,3DCP in corn oil was applkied and covered occlusively for 24 hr
Challenge controls:
Control group animals were created with the same formulation of test material that was applied to test group animals.
Positive control substance(s):
not required

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
other: after patch removal
Hours after challenge:
0
Group:
test chemical
Dose level:
2.5%
No. with + reactions:
20
Total no. in group:
20
Clinical observations:
1/20 Beet red area with well defined edge; 11/20 pink/red area with defined edges; 6/20 slight redness, edges not defined
Remarks on result:
other: see Remark
Remarks:
Reading: other: after patch removal. . Hours after challenge: 0.0. Group: test group. Dose level: 2.5%. No with. + reactions: 20.0. Total no. in groups: 20.0. Clinical observations: 1/20 Beet red area with well defined edge; 11/20 pink/red area with defined edges; 6/20 slight redness, edges not defined.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
2.5%
No. with + reactions:
20
Total no. in group:
20
Clinical observations:
9/20 pink/red area with defined areas; 11/20slight redness, edges not defined
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 2.5%. No with. + reactions: 20.0. Total no. in groups: 20.0. Clinical observations: 9/20 pink/red area with defined areas; 11/20slight redness, edges not defined.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
2.5%
No. with + reactions:
18
Total no. in group:
20
Clinical observations:
8/20 pink/red area with well defined edges, 10/20 slight redenss, edges not defined; 2/20 no difference from surrounding skin
Remarks on result:
other: see Remark
Remarks:
Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 2.5%. No with. + reactions: 18.0. Total no. in groups: 20.0. Clinical observations: 8/20 pink/red area with well defined edges, 10/20 slight redenss, edges not defined; 2/20 no difference from surrounding skin.
Reading:
other:
Hours after challenge:
0
Group:
negative control
Dose level:
0 (corn oil)
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no difference from surrounding skin
Remarks on result:
other: Reading: other:. . Hours after challenge: 0.0. Group: negative control. Dose level: 0 (corn oil). No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no difference from surrounding skin.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0 (corn oil)
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no difference from surrounding skin
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0 (corn oil). No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no difference from surrounding skin.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0 (corn oil)
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no difference from surrounding skin
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0 (corn oil). No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no difference from surrounding skin.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Conclusions:
All 20 test animals showed postive responsies 24 h after removal of the challenge patches and 18 showed postive responses after 48 h. The substance is considered to be a skin sensitiser under the conditions of the test.
Executive summary:

A GLP-compliant guinea pig maximisation test has been conducted according to OECD Guideline 406. All of the twenty test animals showed postive responses at 24 and/ or 48 hours after removal of the challenge patch. The substance is considered to be a skin sensitiser under the conditions of the test.