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EC number: 293-883-9 | CAS number: 91648-24-7
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14 June 1993 to 19 November 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study was performed prior to the adoption of the LLNA as an OECD Test Guideline
Test material
- Reference substance name:
- 1,3-Propanediol, 2,2-bis(hydroxymethyl)-, allyl ether
- EC Number:
- 293-883-9
- EC Name:
- 1,3-Propanediol, 2,2-bis(hydroxymethyl)-, allyl ether
- Cas Number:
- 91648-24-7
- Molecular formula:
- C14H24O4
- IUPAC Name:
- 2,2-bis(hydroxymethyl)propane-1,3-diol; 3-(prop-2-en-1-yloxy)prop-1-ene
- Test material form:
- liquid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- Supplier: David Hall Limited, Burton upon Trent, Staffordshire
Weight of animals at start of study: 345 to 440g
Age at start of study: Approximately 8 to 12 weeks
Acclimitisation period: At least five days
Housing: Groups of up to three animals
Caging: Solid floor polyproplyene cages with softwood shavings
Food: Guinea Pig FDI diet; ad libitum
Water: Main tap water; ad libitum
Temperature: 20 to 26 °C
Humidity: 52 to 67%
Air changes: Approximately 15 changes/hour
Photoperiod: 12 hours light/dark cycle
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- arachis oil
- Concentration / amount:
- 10% (w/v) / 0.1 mL
- Day(s)/duration:
- 7 days
- Adequacy of induction:
- other: Highest concentration that did not cause local necrosis, ulceration or systemic toxicity selected for the intradermal induction stage.
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.2 to 0.3 mL of neat test article occluded
- Day(s)/duration:
- 48 hours
- Adequacy of induction:
- other: Highest concentration producing only mild to moderate dermal irritation after 72 hour occlusive exposure selected for the topical induction stage.
Challengeopen allclose all
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- undiluted / 0.1 to 0.2 mL
- Day(s)/duration:
- 24 hours
- Adequacy of challenge:
- not specified
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- arachis oil
- Concentration / amount:
- 75% (v/v) / 0.1 to 0.2 mL
- Day(s)/duration:
- 24 hours
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 10 test animals and 10 control animals
- Details on study design:
- Preliminary study conducted to determine concentrations for the main study. Induction of four animals was by intradermal injection of the test material at 1%, 5%, 10% or 25% to deteremine the concentration for intredermal induction. Two animals were treatments with undiluted test material, and three preparations of the the test material at 75%, 50% and 25% v/v in arachis oil having been intradermally injected with Freund's complete adjuvant 10 days previously to determine the cocnentrations for topical induction. Two animals were tested with undiluted test material and 75% (w/v) test material in arachis oil occlusively following inducation as per the main study control animals to determine the concentrations for the topical challenge.
For the main test, shortly before treatment, the hair was removed from an area approximately 4 cm x 6 cm on the shoulder region using clippers. A row of three injections was made on each side of the mid line:
i Freund's Complete adjuvant and distilled water at a ratio of 1:1
ii Test material in arachis oil at 10% (w/v)
iii Test matieral in arachis oil at 10% (w/v) in a 1:1 prepation of Freund's Complete Adjuvant plus arachis oil for the test animals or Freunds Complete Adjuvant plus arachis oil in the ratio of 1:1 for the control animals
On Day 6, the nuchal region was clipped and shaved and 0.5 mL of sodium laury sulphate (10 w/w in petrolatum) was applied to provide an inflammatory response. The treatment sites were non-occluded.
On Day 7, the same area on the shoulder region used for the intradermal induction was clipped again and treated with a topical application of undiluted teat material (test animals) or with nothing (control animals). The undiluted test article (0.2 to 0.3 mL) was applied on filter paper which was held in place by a strip of surgical adhesive tape and covered with an overlapping lengtnh of aluminium foil. The same procedure was followed for the control anaimsls, but nothing was included in the filter paper for this group. The patch and foil were furthed secured by a strip of elastic adhesive bandage wound in a double layer around the torso of the animal. The occlusive dressing was kept in palce for 48 hours. Erythematous reactions were quantified one and twenty-four hours followng removal of the patches.
On Day 21, shortly before treatment, an area approximately 5 cm x 7 cm was clipped free of hair. Undiluted test material (0.1 to 0.2 mL) was applied to the shorn right flank of each animal on a square of filter paper. This was held in place by a strip of surgical adhesive tape. The test material at a concentration of 75% (v/v) in arachis oil was also applied to separate skin in the right shorn flank of each animal. The vehcile alone was applied to the shorn left flank of each animal. The patches were occluded with an overlapping length of aluminium foild and secured by a strip of elastic adhesive bandage wound in a double layer around the torso of each animal.
The dressings were removed after 24 hours. The challenge sites were swabbed with cotton wool soaked in diethyl ether to removed residual test material.
Prior to the 24-hur observation, the hair of the test sites was removed by clippers. The skin was evaluated at 24 and 48 hours after challenge dressing removal. - Challenge controls:
- Arachis oil used as a control on all animals.
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- Not applicable
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 75%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 75%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0% - vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0% - vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 75%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 75%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0% - vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0% - vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other:
- Group:
- positive control
- Remarks on result:
- not measured/tested
Any other information on results incl. tables
Results of preliminary study: Intradermal induction
Concentration of test material (% w/v) | Evidence of necrosis | Evidence of systemic toxicity | ||||||
24 hours | 48 hours | 72 hours | 7 days | 24 hours | 48 hours | 72 hours | 7 days | |
1 | None | None | None | None | None | None | None | None |
5 | None | None | None | None | None | None | None | None |
10 | None | None | None | None | None | None | None | None |
25 | None | Necrosis | Necrosis | Eschar | None | None | None | None |
Results of preliminary study: Topical induction
Concentration of test material (% w/v) | Skin reactions after patch removal | ||
1 hours | 24 hours | 72 hours | |
100 | 0 | 0 | 0 |
75 | 0 | 0 | 0 |
50 | 0 | 0 | 0 |
25 | 0 | 0 | 0 |
Results of preliminary study: Topical challenge
Concentration of test material (% w/v) | Skin reactions after patch removal | ||
1 hour | 24 hours | 48 hours | |
100 | 1 | 0 | 0 |
75 | 1 | 0 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- None of the animals showed evidence of sensitisation 24 or 48 hours after a topical challenge.
- Executive summary:
In a skin sensitisation study using the Guinea Pig Maximization Test method according to OECD 406, 10 female guinea pigs assigned to the test group were induced by intradermal injections with a 10% formulation of the test material 1,3-propanediol, 2,2- bis(hydroxymethyl) -, allyl ether in arachis oil. In addition, these guinea pigs were topically induced on Day 7 with undiluted test material. Along with the test animals, a group of 10 negative control female animals, previously not induced with the test material but having undergone intradermal and topical induction in the absence of test material, were challenged topically for 24 hours with neat test material and 75% (v/v) test material in arachis oil. Skin examinations at 24 and 48 hours after the completion of the challenge exposure indicated no positive sensitisation reactions in the test or negative control groups. Based on the results of this study, 1,3-propanediol, 2,2- bis(hydroxymethyl) -, allyl ether was considered not to be a skin sensitiser.
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