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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:
March 22 - April 25 1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well conducted study in accordance with recognised test methods

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
Reduced group size
Principles of method if other than guideline:
Twelve male guinea pigs, weighing 200-300 g, 9 sensitising topical, occluded applications (6 hours/day) over 21 day period, two challenge applications 14 days later, to determine local and systemic effects. Non-irritating concentrations were used initially. DEP used at a concentration of 50%.
GLP compliance:
no
Type of study:
Buehler test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report):
- Molecular formula (if other than submission substance):
- Molecular weight (if other than submission substance):
- Smiles notation (if other than submission substance):
- InChl (if other than submission substance):
- Structural formula attached as image file (if other than submission substance): see Fig.
- Substance type:
- Physical state:
- Analytical purity:
- Impurities (identity and concentrations):
- Composition of test material, percentage of components:
- Isomers composition:
- Purity test date:
- Lot/batch No.:
- Expiration date of the lot/batch:
- Radiochemical purity (if radiolabelling):
- Specific activity (if radiolabelling):
- Locations of the label (if radiolabelling):
- Expiration date of radiochemical substance (if radiolabelling):
- Stability under test conditions:
- Storage condition of test material:
- Other:

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Summit View Farm Belvidere New Jersey
- Age at study initiation: Not reported
- Weight at study initiation: 200-300 g
- Housing: Not reported
- Diet (e.g. ad libitum): Wayne animal feed, rabbit pellets supplemented with kale or lettuce, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: yes; period not specified

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not reported
- Humidity (%): Not reported
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): Not reported

IN-LIFE DATES: From: 22 March To: 25 April 1978

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
100% and 50% w/v aqueous solutions in screening phase.
Main study: 50% w/v aqueous solution
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
100% and 50% w/v aqueous solutions in screening phase.
Main study: 50% w/v aqueous solution
No. of animals per dose:
Screening phase: 1
Main study : 12
Details on study design:
RANGE FINDING TESTS: 1 animal used at each concentrations of 100 and 50% to establish the primary irritation threshold.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 9
- Exposure period: 6 h
- Test groups: 1
- Control group: 0 (none)
- Site: back
- Frequency of applications: 3 times weekly for 3 weeks
- Duration: Until DEP had been applied 9 times
- Concentrations: 50% aqueous solution

B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: 2 weeks after 9th sensitising application
- Exposure period: not stated but assumed to be 6 h
- Test groups: 1
- Control group: 0 (none)
- Site: back and ventrum
- Concentrations: 50% w/v aqueous solution
- Evaluation (hr after challenge): initial and 24 h
Challenge controls:
None used
Positive control substance(s):
no

Study design: in vivo (LLNA)

Statistics:
None

Results and discussion

Positive control results:
None no positive control group on study

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
0
Group:
test group
Dose level:
50% w/v aqueous solution
No. with + reactions:
0
Total no. in group:
11
Clinical observations:
1 guinea pig died before challenge phase and fibrous tissue was found to be encasing the abdominal organs. 11 guinea pigs were challenged.
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 0.0. Group: test group. Dose level: 50% w/v aqueous solution. No with. + reactions: 0.0. Total no. in groups: 11.0. Clinical observations: 1 guinea pig died before challenge phase and fibrous tissue was found to be encasing the abdominal organs. 11 guinea pigs were challenged..
Reading:
2nd reading
Hours after challenge:
24
Group:
test group
Dose level:
50% w/v aqueous solution
No. with + reactions:
0
Total no. in group:
11
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50% w/v aqueous solution. No with. + reactions: 0.0. Total no. in groups: 11.0.

Any other information on results incl. tables

Induction score : 0.0

Topical challenge scores

Initial: 0.0

after 24 h:0.0

Systemic challenge scores

Initial: 0.0

after 24 h:0.0

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Under the conditions of this test DEP is not a skin sensitiser
Executive summary:

Dermal sensitisation has been invstigated using the Buehler method. There was no evidence of sensitisation to diethyl phthalate.