Registration Dossier
Registration Dossier
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EC number: 224-709-1 | CAS number: 4457-71-0
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- No non-animal approach to assess skin sensitisation was available at the time the study was initiated.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study was conducted in 1995, before validation of the non-animal testing strategy and the local lymph node assay.
Test material
- Reference substance name:
- 3-methylpentane-1,5-diol
- EC Number:
- 224-709-1
- EC Name:
- 3-methylpentane-1,5-diol
- Cas Number:
- 4457-71-0
- Molecular formula:
- C6H14O2
- IUPAC Name:
- 3-methylpentane-1,5-diol
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): 3-methyl-1,5-pentanediol MPD
- Physical state: liquid
- Analytical purity: >99 %
- Lot/batch No.: 52724
- Test substance recieved on (date): 30 September 1994
- Expiry date: end of 1996
- Storage condition of test material: room temperature in the dark
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: d. Hall, Newchurch, Staffordshire, England
- Age at study initiation: approx. 4 to 5 weeks
- Weight at study initiation: 305 - 358 g
- Housing: 5/suspended wire mesh cage
- Diet: vitamin C enriched guinea-pig diet FD1 ad libitum
- Water: drinking water ad libitum
- Acclimation period: 5 days prior to allocation to the main study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): approx. 21 °C
- Humidity (%): 30-70
- Air changes (per hr): approx. 15 per hr
- Photoperiod (hrs dark / hrs light): 12 h/12 h
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- INDUCTION
intradermal: 5% (v/v)
dermal: neat
CHALLENGE
dermal: neat and 50% (v/v)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- INDUCTION
intradermal: 5% (v/v)
dermal: neat
CHALLENGE
dermal: neat and 50% (v/v)
- No. of animals per dose:
- Test animals: 10
positive control animals: 5 - Details on study design:
- 1st application: Induction 5 % (v/v) intradermal injection
2 st application: Induction neat epicutaneous
3 st application: Challenge neat and 50 % (v/v) epicutaneous - Positive control substance(s):
- yes
- Remarks:
- Hexyl cinnamic aldehyde (positive control test periodically performed). Dose levels (aqueous dilutions): Intradermal induction: 10% Topical induction: as supplied Challenge: as supplied and 50%
Results and discussion
- Positive control results:
- The sensitivity of the guinea pig strain used was checked periodically. The report included results of 3 recently performed positive control test (start dates 08.12.92, 20.07.93 and 15.03.94). The tests resulted in 10/10, 9/10 and 10/10 positive animals, respectively.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100% and 50%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100% and 50%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 100% and 50%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- as supplied and 10%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- No details given
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100% and 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No adverse skin reactions reported
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100% and 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No adverse skin reactions reported
- Key result
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 100% and 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No adverse skin reactions reported
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100% and 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No adverse skin reactions reported
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100% and 50%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No adverse skin reactions reported
- Key result
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 100% and 50%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No adverse skin reactions reported
Any other information on results incl. tables
No adverse skin reactions were noted at the test material or vehicle control sites of the test or control animals at 24, 48 and 72 h observations.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The guinea-pig maximization test found that 3-methyl-1,5-pentanediol (neat and 50% in water) did not elicit a delayed contact hypersensitivity response in guinea pigs. Appropriate concurrent negative controls were included and the expected responses observed.
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