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EC number: 261-605-5 | CAS number: 59113-36-9
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14Oct2008 - 13Nov 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was performed according to current OECD guidelines and GLP principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted 17 July 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- Council regulation No. 440/2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- we have used "Acceptable guinea pig maximisation test that followed sound scientific principles."
Test material
- Reference substance name:
- Diglycerin
- IUPAC Name:
- Diglycerin
- Details on test material:
- - Substance name: Diglycerin 801
- Batch No.: 80902-4
- Substance type: colorless gel
- Storage conditions: Room temperature, darkness
- Purity: 99.8%
- Cas No.: 59113-36-9; 25618-55-7
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River (F69592 l'Arbresle)
- Age at study initiation: 4 weeks
- Weight at study initiation: 260-293 g
- Housing: in groups of 2 or 3 in polycarbonate containers
- Diet: ad libitum
- Water: ad libitum
- Acclimation period:≤ 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- physiological saline
- Remarks:
- isotonic sodium chloride
- Concentration / amount:
- 1. Induction intradermal injection: 12.5% (maximal non necrotizing concentration found in preliminary study).
2. Induction topical application: 100% (undiluted substance did not give a cutaneous reaction in preliminary study).
3. Challenge phase: 100% and 50%.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Remarks:
- isotonic sodium chloride
- Concentration / amount:
- 1. Induction intradermal injection: 12.5% (maximal non necrotizing concentration found in preliminary study).
2. Induction topical application: 100% (undiluted substance did not give a cutaneous reaction in preliminary study).
3. Challenge phase: 100% and 50%.
- No. of animals per dose:
- 11 test animals
5 control animals - Details on study design:
- RANGE FINDING TESTS:
The intradermal and topical irritancy of a range of dilutions of the test substance was investigated to identify (a) concentrations of
the test substance that would produce irritation suitable for the induction phase of the main study and (b) a maximum non-irritant concentration
by the topical route of administration for the challenge phase.
MAIN STUDY
A. INDUCTION EXPOSURE
(1) INTRADERMAL INDUCTION
- No. of exposures: three pairs
- Volume = 0.1ml
- Exposure period: 6 days
- Test group: Two intradermal injections with Freund's Complete Adjuvant diluted at 50%; Two intradermal injections with test substance at 12.5%; Two intradermal injections with Freund's Complete Adjuvant at 50% and the test item at 25%.
- Control group: treated similarly to the test animals with the exception that the test substance was omitted from the intradermal injections
- Site:40x60 mm area of dorsal skin on the scapular region
(2) INDUCTION TOPICAL APPLICATION
- On day 6, skin was brushed with a solution of sodium lauryl sulfate at 10% in thick vaseline
- On day 7: application of test substance
- No. of exposures: 1
- Exposure period: 48 hours
- Test groups: 0.5 ml of the test item at 100%
- Control group: 0.5 ml distilled water
- Site: 40x60 mm area of dorsal skin on the scapular region (same area as in (1))
B. CHALLENGE EXPOSURE
- No. of exposures: the control and test animals
- Day of challenge: 21
- Exposure period: 24 hours (occlusive)
- Both groups: 1 sample cup containing the test item at 100% or 50%
- Evaluation (hr after challenge): 24 and 48
Interpretation of results: An answer over at least 30% of animals is regarded as positive - Positive control substance(s):
- yes
- Remarks:
- alpha-hexylcinnamaldehyde
Results and discussion
- Positive control results:
- Positive control data presented are historical data and were within acceptabel range according to the guidelines.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 2
- Total no. in group:
- 11
- Clinical observations:
- Slight or patches of erythema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 2.0. Total no. in groups: 11.0. Clinical observations: Slight or patches of erythema.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 11
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 11.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 11
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 11.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 11
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 11.0.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In a skin sensitisation test in the guinea pig (Magnusson and Kligman maximisation method) according to the current OECD guideline under GLP circumstances, the test substance was found to be not sensitising.
- Executive summary:
A skin sensitisation test with 11 guinea pigs (Magnusson and Kligman maximisation method) according to the current OECD guideline and GLP priniples was performed. At 24 hours after challenge with 100% of the substance, two animals had slight or patches of erythema. No reaction was seen after exposure with 50% substance. No mortality was registered during the test. No abnormalities were found in body weight gain in any of the animals. Based on the results, the test substance was found to be not sensitising.
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