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Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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
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
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
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
100% and 50% w/v aqueous solutions in screening phase.
Main study: 50% w/v aqueous solution
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
Statistics:
None
Positive control results:
None no positive control group on study
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.

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

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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Dermal sensitisation has been invstigated using the Buehler method. There was no evidence of sensitisatioin to diethyl phthalate. In a comparison of guinea pig sensitisation tests by Klecak et.al. ( J Soc Cosmet Chem 28: 53 -64, 1977) diethyl phthalate was not a skin sensitiser in the open epicutaneous test, Draize test, Maximisation test and Freund's complete aduvant test

Skin sensitisation has also been investigated in the more recent local lymph node assay (LLNA) and, again, diethyl phthalate was not sensitisating


Migrated from Short description of key information:
Skin sensitisation: Not sensitising

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Information available from a number of dermal sensitisation assays show no evidence that the substance induces or elicits sensitisatio. Classification is therefore not warrented.