Registration Dossier
Registration Dossier
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EC number: 211-745-8 | CAS number: 693-21-0
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 7.3. - 15.4.1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well documented study report which meets basic scientific principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: Dermal Sensitization. In: Health effects test guidelines. Washington, DC: EPA, Aug 1982, EPA 560/6-82-001
- Deviations:
- yes
- Remarks:
- See Overall remarks
- Qualifier:
- according to guideline
- Guideline:
- other: Buehler dermal sensitization test. LAIR Standard Operating Procedure OP-STX-82, Letterman Army Institute of Research, Presidio of San Francisco, CA. 18 May 1984
- Deviations:
- yes
- Remarks:
- See Overall remarks
- GLP compliance:
- yes
- Type of study:
- Buehler test
Test material
- Reference substance name:
- Oxydiethylene dinitrate
- EC Number:
- 211-745-8
- EC Name:
- Oxydiethylene dinitrate
- Cas Number:
- 693-21-0
- Molecular formula:
- C4H8N2O7
- IUPAC Name:
- 2-[2-(nitrooxy)ethoxy]ethyl nitrate
- Details on test material:
- - Name of test material (as cited in study report): Diethyleneglycol dinitrate (DEGDN)
- Physical state: pale yellow liquid
- Analytical purity: 96.6%
- Impurities (identity and concentrations): not identified
- Stability under test conditions: stable
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories, Wilmington, MA
- Age at study initiation: 1 month
- Weight at study initiation: 336 - 481 g
- Housing: individually in stainless steel wire mesh cages in racks equipped with automatically flushing dumptanks, no bedding used.
- Diet (e.g. ad libitum): Certified Purina Guinea Pig Chow® Diet 5026
- Water (e.g. ad libitum): from central line
- Acclimation period: 19 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.2 - 27.8°C
- Humidity (%): 32 - 50%
- Photoperiod (hrs dark / hrs light): 12 hours of light per day
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- undiluted DEGDN (100%)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- undiluted DEGDN (100%)
- No. of animals per dose:
- 10 animals
- Details on study design:
- RANGE FINDING TESTS: A pilot study, using extra animals from a previous study, indicated the 100% solution to be nonirritating under the conditions of this test. Since no vehicle was needed to dilute the diethyleneglycol dinitrate.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Test groups: DEGDN
- Control group: Since no vehicle was needed to dilute the diethyleneglycol dinitrate a vehicle control group was not used.
- Site:L flank
- Frequency of applications: once a week for three weeks
- Duration: 3 weeks
- Concentrations: undiluted
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: two weeks following the third induction dose
- Exposure period: 6 hour
- Test groups: DEGDN
- Control group: The negative control group received diethyleneglycol dinitrate only on the day of challenge dosing. To distinguish between reactions from primary irritation and sensitization a negative control group was added that received undiluted diethyleneglycol dinitrate only on the day of challenge dosing. Ten males was used.
- Site: both flanks
- Concentrations: undiluted
- Evaluation (hr after challenge): 24, 48 and 72 hours
OTHER: - Positive control substance(s):
- yes
- Remarks:
- 1-chloro-2,4-dinitrobenzene (DNCB)
Results and discussion
- Positive control results:
- Dinitrochlorobenzene (DNCB) produced a marked response at all time points after the second and third induction doses, as well as after the challenge dose. Between 90% and 100% of the DNCB-treated animals exhibited a response 24 h following these induction and challenge doses. These reactions persisted, yielding scorable effects in 50-70% of the animals at 72 h after dosing.
Beginning with the second induction, severity scores for these responses to DNCB ranged from 0.6 to 1.4 at the 24 h scoring period. The highest score, 1.4, was observed on the left (induction) flank in response to the challenge dose. By 48 h the reactions had subsided somewhat and the severity scores ranging from 0.6 to 1.1 reflected this decrease. A further reduction was evident by 72 h, with the severity index ranging between 0.5 and 0.8.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5 mL of undiluted DEGDN
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5 mL of undiluted DEGDN. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5 mL of undiluted DEGDN
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.5 mL of undiluted DEGDN. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 0.5 mL of undiluted DEGDN
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 0.5 mL of undiluted DEGDN. No with. + reactions: 0.0. Total no. in groups: 10.0.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Diethyleneglycol dinitrate exhibited no potential for inducing dermal sensitization under conditions of this study.
- Executive summary:
Diethylerieglycol dinitrate (DEGDN) was tested for its potential to produce sensitization via contact with the skin. Testing was performed on male guinea pigs using the Buehler Dermal Sensitization method. No evidence of dermal sensitization to DEGDN was obtained in this study.
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