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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:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
Data is from secondary source.

Data source

Reference
Reference Type:
secondary source
Title:
Initial Risk-Based Prioritization of High Production Volume (HPV) Chemicals, CAS no: 102-06-7 1, 3-Diphenylguanidine
Author:
U.S. Environmental Protection Agency
Year:
2009
Bibliographic source:
U.S. Environmental Protection Agency Risk-Based Prioritization Document, April 2009

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Principles of method if other than guideline:
Skin sensitization study of 1, 3-Diphenylguanidine was performed in guinea pig by Guinea pig maximization test
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Not specified.

Test material

Constituent 1
Reference substance name:
1, 3-Diphenylguanidine
Cas Number:
102-06-7
Molecular formula:
C13H13N3
IUPAC Name:
1, 3-Diphenylguanidine
Test material form:
solid
Details on test material:
- Name of test material (as cited in study report): 1, 3-Diphenylguanidine
- Molecular formula: C13H13N3
- Molecular weight:211.267 g/mole
- Substance type: organic
- Physical state: solid
Specific details on test material used for the study:
- Name of test material (as cited in study report): 1, 3-Diphenylguanidine
- Molecular formula: C13H13N3
- Molecular weight:211.267 g/mole
- Substance type: organic
- Physical state: solid


In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
No data available

Study design: in vivo (non-LLNA)

Induction
Route:
other: intradermal and epicutaneous, occlusive
Vehicle:
paraffin oil
Concentration / amount:
Intradermal injection :0.1ml of 1.0%w/w
Topical application :0.5ml of 25%w/w
Day(s)/duration:
48hr
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
paraffin oil
Concentration / amount:
0.5ml of 25%w/w
Day(s)/duration:
24hr
No. of animals per dose:
Total :15
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures:2
- Exposure period:48hr
- Test groups:15
- Control group: No data available

- Site: No data available

- Frequency of applications: on day 1 intradermal injection
On day 8 cutaneous application

- Duration:48hr
- Concentrations: Intradermal injection :0.1ml of 1.0%w/w
Topical application :0.5ml of 25%w/w
B. CHALLENGE EXPOSURE
- No. of exposures: 1

- Day(s) of challenge: 12 days
- Exposure period: 24hr
- Test groups: 15
- Control group: No data available

- Site: No data available

- Concentrations: 0.5ml of 25%w/w
- Evaluation (hr after challenge): 24hr and 48hr


OTHER: Freund’s complete adjuvant was given during intradermal induction
Challenge controls:
No data available
Positive control substance(s):
not specified

Study design: in vivo (LLNA)

Statistics:
No data available

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.5 mL of 25% (w/w)
No. with + reactions:
0
Total no. in group:
15
Clinical observations:
No sensitization reaction was observed
Remarks on result:
no indication of skin sensitisation
Remarks:
Test material was not skin sensitizing in guinea pig

In vivo (LLNA)

Cellular proliferation data / Observations:
CLINICAL OBSERVATIONS: No skin sensitization reaction was observed.

Any other information on results incl. tables

No skin sensitization reaction was observed.

Applicant's summary and conclusion

Interpretation of results:
other: Not sensitizing
Conclusions:
The skin sensitization study of 1, 3-Diphenylguanidine (102-06-7) was performed in guinea pig . The test result was determined to be not sensitizing.
Executive summary:

The skin sensitization study of 1, 3-Diphenylguanidine (102 -06 -7) was performed in 15 guinea pigs by using Guinea pig maximization test.In induction phase, on 1stday intradermal injection of 0.1ml of 1.0%w/w1, 3-Diphenylguanidine in paraffin oil in presence ofFreund’s complete adjuvant was given .on day 8, occlusive dressing of0.5 ml of 25%w/w1, 3-Diphenylguanidine in paraffin oil was applied for 48hr.In challenge phase, after 12 days 0.5 ml of 25%w/w1, 3-Diphenylguanidine in paraffin oil was applied for 24hr, as occlusive patch. The evolution done 24hr and 48hr after removal of challenge application.No sensitization reaction was observed at application site .Hence it is considered that 1, 3-Diphenylguanidine(102 -06 -7) was not skin sensitizing in guinea pig.