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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:
key study
Study period:
From 31 May 1979 To 11 Jul 1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
occlusive patch held for 24 hours instead of 6 hours; 10 instead of 20 animals
Principles of method if other than guideline:
Modified Buehler-test with 10 inductions
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Currently no LLNA study is available for assessment. The Guinea Pig Maximization Test (GPMT) has been carried out as an animal test to predict human sensitization for over a decade and is recommended by international test guidelines such as OECD.

Test material

Constituent 1
Chemical structure
Reference substance name:
Bis(2-propylheptyl) phthalate
EC Number:
258-469-4
EC Name:
Bis(2-propylheptyl) phthalate
Cas Number:
53306-54-0
Molecular formula:
C28H46O4
IUPAC Name:
bis(2-propylheptyl) phthalate
Test material form:
liquid

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: albino
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: between 300 and 400 g
- Housing: housed and maintained in compliance with the Animal Welfare Act (Pub. L-94-279) 9 CFR part 3

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100%; 0.5 g
Challenge
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100%; 0.5 g
No. of animals per dose:
5 male and 5 female
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10
- Exposure period: 20 d
- Test groups: 10 animals
- Control group: no
- Site: the same intact skin test site
- Patch: gauze patch was placed over the treated area and an impervious material was wrapped tightly around the trunks of the animals to hold the patch in place.
- Frequency of applications: every second day
- Duration: 24 h
- Concentrations: 100%

B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: after a 14 day rest period
- Exposure period: 24 h
- Test groups: 10 animals
- Control group: no
- Site: other skin site than used for induction
- Concentrations: 100%
- Evaluation (hr after challenge): 24, 48 h

SCORING
Sites were examined for irritation (if any) using the Draize Method of Scoring.
Challenge controls:
no
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Group:
positive control
Remarks on result:
not measured/tested
Group:
negative control
Remarks on result:
not measured/tested

Any other information on results incl. tables

Individual scoring:

Animal Sex Irritation Readings after application No. Challenge
1 2 3 4 5 6 7 8 9 10 24 h 48 h
1 M Erythema 0 0 0 0 0 0 0 0 0 0 0 0
Edema 0 0 0 0 0 0 0 0 0 0 0 0
2 M Erythema 0 0 0 0 1 1 1 1 1 1 0 0
Edema 0 0 0 0 0 0 0 0 0 0 0 0
3 M Erythema 0 0 0 0 1 1 1 1 1 1 0 0
Edema 0 0 0 0 0 0 0 0 0 0 0 0
4 M Erythema 0 0 0 0 0 0 0 0 0 0 0 0
Edema 0 0 0 0 0 0 0 0 0 0 0 0
5 M Erythema 0 0 0 0 1 1 1 1 1 1 0 0
Edema 0 0 0 0 0 0 0 0 0 0 0 0
6 F Erythema 0 0 0 0 0 0 0 0 0 0 0 0
Edema 0 0 0 0 0 0 0 0 0 0 0 0
7 F Erythema 0 0 0 0 0 0 0 0 0 0 0 0
Edema 0 0 0 0 0 0 0 0 0 0 0 0
8 F Erythema 0 0 0 0 0 1 1 0 1 1 0 0
Edema 0 0 0 0 0 0 0 0 0 0 0 0
9 F Erythema 0 0 0 0 0 0 0 0 0 0 0 0
Edema 0 0 0 0 0 0 0 0 0 0 0 0
10 F Erythema 0 0 0 0 0 0 0 0 0 0 0 0
Edema 0 0 0 0 0 0 0 0 0 0 0 0

The test substance was not a primary irritant. It is not a skin sensitizer.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met