Diethyl phthalate

Skin sensitisation

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

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

Test material information

Constituent 1

Reference substance name:

Diethyl phthalate

EC Number:

201-550-6

EC Name:

Diethyl phthalate

Cas Number:

84-66-2

Molecular formula:

C12H14O4

IUPAC Name:

.

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)

Induction

Induction 1

Route:

epicutaneous, occlusive

Vehicle:

water

Induction 2

Concentration / amount:

100% and 50% w/v aqueous solutions in screening phase.
Main study: 50% w/v aqueous solution

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

water

Challenge 2

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)

Results

Results 1

Reading:

1st reading

Hours after challenge:

0

Group:

test chemical

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..

Results 2

Reading:

2nd reading

Hours after challenge:

24

Group:

test chemical

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.