Registration Dossier
Registration Dossier
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EC number: 946-420-6 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1991-01-08 to 1991-02-01
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- May 12, 1981
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A valid GPMT conducted according to guideline is available, which is reliable with restrictions and adequate for classification and labelling purposes. Potency estimation is not mandatory when existing guideline and GLP conforming data are available, which were conducted before the new annex of the REACH Regulation entered into force. Moreover, no indication for skin sensitisation was observed in this study, thus, no dose response information is needed. For this reason and for reasons of animal welfare no additional LLNA was conducted.
Test material
- Reference substance name:
- Decanoic acid, monoester with oxybis[propanediol]
- Molecular formula:
- C16H32O6
- IUPAC Name:
- Decanoic acid, monoester with oxybis[propanediol]
- Test material form:
- liquid: viscous
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 256-375 g
- Housing: Collective housing up to a maximum of 5 animals per cage (Macrolon type IV),
- Diet (e.g. ad libitum): ad libitum, Ssniff-G (Alleindiät für Meerschweinchen), pellets, 1.0 cm long, 0.5 cm diameter (SsniffSpezialdiäten GmbH, 4770 Soest/Westfalen
- Water (e.g. ad libitum): ad libitum, drinking water as for human consumption from Macrolon drinking bottles, Becker & Co., 460 Castrop-Rauxel
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): Artificial lighting (120 lux), 12 h light/ 12 h dark cycle
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- 1% intradermal; 100% epicutaneous
- Day(s)/duration:
- day 0: intradermal; day 7 dermal application for 48 h
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 5%
- Day(s)/duration:
- day 21, 24 h
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 10 female and 10 male (test + control group)
- Details on study design:
- RANGE FINDING TESTS: yes, the test item was both intrdermal and dermal applied. The following concentrations were used: Intradermal injections: 0.5, 1 and 5%, dermal application: 5, 10, 25, 50 and 100 %. Liquids were used at the highest concentration which did not produce excessive inflammation.
MAIN STUDY
A. INDUCTION EXPOSURE
- Intradermal (day 0)
- Exposure period: intradermal at first stage and after 7 days dermal application for 48 h at second stage
- Test groups:
- 0.1 mL FCA (1:2 in water)
- 0.1 mL test item in water (1% final concentration)
- 0.1 mL test item emulsified in FCA (1% final concentration)
- Control group:
- 0.1 mL FCA (1:2 in water)
- 0.1 mL vehicle
- 0.1 mL vehicle emulsified in FCA (1:2 in FCA)
- Topical Application (day 7)
- Test Group: undiluted test item
- Control Group: vehicle
- Site: An area of 4 x 6 cm over the shoulders, same area as before
- Frequency of applications: First application intradermal and after 7 days dermal application for 48 h.
- Concentrations: Intradermal application 1% and dermal application 100%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 21 (14 d after second induction exposure)
- Exposure period: 24 h
- Test groups: test item
- Control group: test item
- Site: left flank for test item and right flank for control
- Concentrations: 5%
- Evaluation (hr after challenge): 24 and 48 h
- Challenge controls:
- 10 m + 10 f treated identically, but without test item (only vehicle); challenge: identical to test group
- Positive control substance(s):
- yes
- Remarks:
- 2,4- dinitrochlorobenzene (extreme sensitizer) and benzocaine (mild sensitizer); last test performed in October, 1990.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no adverse effects observed
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No adverse effects observed
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Group:
- positive control
- Remarks on result:
- other: detailed results not in the report
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Polyglyceryl-2 caprinate is not a dermal sensitiser in this GPMT study.
- Executive summary:
In a dermal sensitisation study according to OECD Guideline 406 (1981) with Polyglyceryl-2 caprinate young adult male and female Pirbright-Hartley guinea pigs (10/sex/group) were tested using the GPMT method.
Based on the results of a preliminary study, the test substance was used at 1% dilution for the intradermal induction (no specific findings), undiluted for epicutaneous induction (slight to moderate erythema) and at 5% dilution (no skin irritation) for the challenge exposure.
Clinical signs, body weight and any skin reactions were evaluated 24 h and 48 h after patch removal. There were no effects observed in the control and the treatment group (sensitisation rate = 0%), thus,
Polyglyceryl-2 caprinate is not a dermal sensitiser in this study.
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