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Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from handbook or collection of data

Data source

Referenceopen allclose all

Reference Type:
other: Authoritative database
Title:
determination of Skin sensitization for CAS no: 117-81-7
Author:
HSDB
Year:
2017
Bibliographic source:
U.S. National Library of Medicine National Institutes of Health, Health & Human Services
Reference Type:
secondary source
Title:
European Union Risk Assessment Report-bis(2-ethylhexyl)phthalate (DEHP)
Author:
European Chemicals Bureau
Year:
2008
Bibliographic source:
European Union Risk Assessment Report-bis(2-ethylhexyl)phthalate (DEHP); 2nd Priority List, Volume: 80; Final Report, 2008 Sweden.

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
Magnusson-Kligman guinea pig maximization test was performed for chemical Bis(2-ethylhexyl)phthalate (CAS no: 117-81-7) in female albino Dunkin-Hartley guinea pigs to assess its skin sensitization potential.
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
1,2-Benzenedicarboxylic acid bis (2-ethylhexyl) ester
Cas Number:
117-81-7
Molecular formula:
C24H38O4
IUPAC Name:
1,2-Benzenedicarboxylic acid bis (2-ethylhexyl) ester
Test material form:
liquid
Details on test material:
Name of the test chemical: 1,2-Benzenedicarboxylic acid bis (2-ethylhexyl) ester
Common Name: bis(2-ethylhexyl)phthalate (DEHP)
Molecular Formula: C24H38O4
Molecular Weight: 390.5602 g/mol
InChI: 1S/C24H38O4/c1-5-9-13-19(7-3)17-27-23(25)21-15-11-12-16-22(21)24(26)28-18-20(8-4)14-10-6-2/h11-12,15-16,19-20H,5-10,13-14,17-18H2,1-4H3
Smiles:CCCCC(CC)COC(=O)c1ccccc1C(=O)OCC(CC)CCCC
Substance Type: Organic
Physical State: Liquid
Specific details on test material used for the study:
Name of the test chemical: 1,2-Benzenedicarboxylic acid bis (2-ethylhexyl) ester
Common Name: bis(2-ethylhexyl)phthalate (DEHP)
Molecular Formula: C24H38O4
Molecular Weight: 390.5602 g/mol
InChI: 1S/C24H38O4/c1-5-9-13-19(7-3)17-27-23(25)21-15-11-12-16-22(21)24(26)28-18-20(8-4)14-10-6-2/h11-12,15-16,19-20H,5-10,13-14,17-18H2,1-4H3
Smiles:CCCCC(CC)COC(=O)c1ccccc1C(=O)OCC(CC)CCCC
Substance Type: Organic
Physical State: Liquid

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: albino Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
No data available

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
paraffin oil
Concentration / amount:
intradermal : 3 injections
• Freund’s adjuvant alone (0.1 ml)
• 10% DEHP in paraffin oil (0.1 ml)
• 10% DEHP in paraffin oil emulsified with 0.05 ml Freund’s adjuvant (0.05 ml).


epicutaneous: 50% DEHP in paraffin oil
Day(s)/duration:
intradermal :7 days epicutaneous: 48 hours
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
paraffin oil
Concentration / amount:
50% DEHP in paraffin oil
Day(s)/duration:
24 hours
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
No data available
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE: Intradermal
- No. of exposures: 1
- Exposure period: 7 days
- Test groups: no data
- Control group: no data
- Site: the skin of the shoulder region
- Frequency of applications: no data
- Duration: 7 days
- Concentrations: 3 injections
• Freund’s adjuvant alone (0.1 ml)
• 10% DEHP in paraffin oil (0.1 ml)
• 10% DEHP in paraffin oil emulsified with 0.05 ml Freund’s adjuvant (0.05 ml).

A. II.INDUCTION EXPOSURE
- No. of exposures: 1
- Exposure period: 48 hours
- Test groups: no data
- Control group: no data
- Site: pre-treated area
- Frequency of applications: no data
- Duration: no data
- Concentrations: 50% DEHP in paraffin oil

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 14 days later
- Exposure period: 24 hours
- Test groups: no data
- Control group: no data
- Site: on the right flank
- Concentrations: 50% DEHP
- Evaluation (hr after challenge): 24 hours after removal of the challenge patch
Challenge controls:
The control group received 2 injections of Freund’s adjuvant only.
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50%
No. with + reactions:
0
Clinical observations:
No skin sensitization was observed in treated guinea pigs.
Remarks on result:
no indication of skin sensitisation

In vivo (LLNA)

Cellular proliferation data / Observations:
No skin sensitization was observed in treated guinea pigs.

Applicant's summary and conclusion

Interpretation of results:
other: Not sensitizing
Conclusions:
The chemical Bis(2-ethylhexyl)phthalate (CAS no: 117-81-7) can be considered as not skin sensitizing to the guinea pigs’ skin in Magnusson-Kligman guinea pig maximization test.
Executive summary:

Magnusson-Kligman guinea pig maximization test was performed for chemicalBis(2-ethylhexyl)phthalate (CAS no: 117-81-7)in female albino Dunkin-Hartley guinea pigs to assess its skin sensitization potential.

 

The induction procedure consisted of an intradermal injection of the test material followed by a topical application 7 days later. The guinea pigs received intradermal injection (actually 3 injections) of 0.1 ml Freund’s adjuvant alone, 0.1 ml 10% DEHP in paraffin oil, and 0.05 ml 10% DEHP in paraffin oil emulsified with 0.05 ml Freund’s adjuvant into the skin of the shoulder region. The control group received 2 injections of Freund’s adjuvant only.

 

For the topical application, a 2.2 cm patch of filter paper was wetted with 50% DEHP in paraffin oil and applied for 48 hours to the pre-treated area. The control group was not subjected to topical application.

 

After rest period of 14 days, the animals were challenged topically at higher non irritating concentration of concentrations 50% DEHP. A 2.2 cm patch wetted with 50% DEHP was applied to a challenge site (on the right flank) of all animals for 24 hours. The degree of response was assessed 24 hours after removal of the challenge patch and rated. Any animal showing erythema at the challenge site was considered to have shown a positive response.

 

Since there were no positive responses, the chemical Bis(2-ethylhexyl)phthalate (CAS no: 117-81-7)can be considered as not skin sensitizing to the guinea pigs’ skin.