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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Remarks:
1,2-Dichloropropane
Type of information:
experimental study
Remarks:
1,2-Dichloropropane
Adequacy of study:
key study
Study period:
1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Justification for type of information:
The substance 1,2-Dichloropropane is an isomer of the substance 1,3-Dichloropropane. In regard to its toxical properties , it is more critical than 1,3-Dichloropropane.

Data source

Reference
Reference Type:
publication
Title:
Allergic contact dermatitis from 1,2-dichloropropane
Author:
Baruffini A, Cirla AM, Pisati G, Ratti R, Zedda S
Year:
1989
Bibliographic source:
Contact Dermatitis 20: 379

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
OECD ENVIRONMENT DIRECTORATE JOINT MEETING OF THE CHEMICALS COMMITTEE AND THE WORKING PARTY ON CHEMICALS, PESTICIDES AND BIOTECHNOLOGY NEW GUIDANCE DOCUMENT ON AN INTEGRATED APPROACH ON TESTING AND ASSESSMENT (IATA) FOR SKIN CORROSION AND IRRITATION Series on Testing and Assessment No. 203 ENV/JM/MONO(2014)19
GLP compliance:
no
Type of study:
patch test
Justification for non-LLNA method:
available Human Patch Test data

Test material

Constituent 1
Chemical structure
Reference substance name:
1,2-dichloropropane
EC Number:
201-152-2
EC Name:
1,2-dichloropropane
Cas Number:
78-87-5
Molecular formula:
C3H6Cl2
IUPAC Name:
1,2-dichloropropane
Test material form:
liquid
Specific details on test material used for the study:
no data available

In vivo test system

Test animals

Species:
other: Homo sapiens
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
4 groups of workers (6 to10/test cohort) and control cohort (120 not otherwise specified test persons)

Study design: in vivo (non-LLNA)

No. of animals per dose:
6 to 10
Details on study design:
1,2-Dichloropropane in petrolatum

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
other: patch test
Hours after challenge:
48
Group:
test chemical
Dose level:
1 % 1,2-Dichloropropane in petrolatum
No. with + reactions:
2
Total no. in group:
6
Clinical observations:
none reported
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
other: patch test
Hours after challenge:
48
Group:
test chemical
Dose level:
2 % 1,2-Dichloropropane in petrolatum
No. with + reactions:
7
Total no. in group:
7
Clinical observations:
none reported
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
other: patch test
Hours after challenge:
48
Group:
test chemical
Dose level:
5 % 1,2-Dichloropropane in petrolatum
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
none reported
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
other: patch test
Hours after challenge:
48
Group:
positive control
Dose level:
20 % 1,2-Dichloropropane in petrolatum
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
none reported
Remarks on result:
positive indication of skin sensitisation
Reading:
other: patch test
Hours after challenge:
48
Group:
negative control
Dose level:
20 % in petrolanum
No. with + reactions:
2
Total no. in group:
120
Clinical observations:
none reported
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
Category 1B (indication of skin sensitising potential) based on GHS criteria
Conclusions:
Human Patch Test with 1,2-dichloropropane demonstrates allergic contact dermatitis. Read across: 1,3 -Dichloropropane is assumed to be a sensitizer.
Executive summary:

1,2-dichloropropane caused allergic contact dermatitis in a 48 h patch test with 1 %, 2 %, 5 %, 10 % and 20 % 1,2-dichloropropane in petrolatum. Positive reactions were highest in pre-exposed workers, with 33 % incidence (2 out of 6) workers at the 1 % concentration ,ad 100 % at the higher levels. Negative results were obtained in a cohort of 120 control persons, with only 2 positive reactions to 20 % 1,2-dichloropropane suggesting that the similar compound 1,2 -Dichloropropane is a sensitizer.

1,3 -Dichloropropane is assumed to be a sensitizer.