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EC number: 253-462-2 | CAS number: 37321-62-3
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20 Jun - 02 Sep 1992
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Data on reliability check not in study report.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted in 1992
- Deviations:
- yes
- Remarks:
- no data on reliability check included.
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A non-LLNA test is available that was performed prior to the current data requirements, stipulated in Regulation (EC) No 1907/2006. In accordance with the same Regulation, the data was included to avoid unnecessary testing.
Test material
- Reference substance name:
- Dodecanoic acid, ester with 1,2-propanediol
- EC Number:
- 253-462-2
- EC Name:
- Dodecanoic acid, ester with 1,2-propanediol
- Cas Number:
- 37321-62-3
- Molecular formula:
- C15H30O3 C27H52O4
- IUPAC Name:
- Dodecanoic acid, ester with 1,2-propanediol
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Remarks:
- Pirbright White Bor: DHPW [SPF]
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: young adults
- Weight at study initiation: 390 - 532 g (males)
- Housing: animals were housed in groups of at the most 5 animals in Makrolon IV cages.
- Diet: Ssniff G4 - Alleindiät für Meerschweinchen (Ssniff Spezialfutter GmbH, Soest, Germany), ad libitum
- Water: tap water (Gelsenwasser, Haltern, Germany), ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- 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
- Vehicle:
- corn oil
- Concentration / amount:
- 10%
- Day(s)/duration:
- single injection on Day 0
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- Day(s)/duration:
- On day 7 for 48 hours
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- Day(s)/duration:
- On day 21 for 24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Range finding study:
2 (intradermal application)
4 (epicutaneous application)
Main study:
10 (controls), 20 (in test group) - Details on study design:
- RANGE FINDING TESTS:
To assess the intracutaneous tolerability of the test substance 2 animals were treated on the left shoulder region. The intracutaneous treatment was applied to groups of 2 animals in concentrations of 0.25, 0.5, 1.0, 2.5, 5.0 and 10.0% in the vehicle corn oil, and evaluated 24 h post appication. Occlusive dermal application of the test substance was conducted in 4 animals for 24 h in concentrations of 2.5, 25, 50 and 100% of the test substance. Dermal reactions were evaluated 48 and 72 h after application. Results of the prelimimary test are presented in Table 1 under "Any other information on results incl. tables".
Based on the results of the range finding test, concentrations of 10% and 100% were selected for intradermal and epicutanous treatment, respectively.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous, respectively)
- Exposure period: single injection (intradermal) and 48 h (epicutaneous)
- Test groups:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture (v/v) FCA/NaCl solution
Injection 2: test substance in corn oil
Injection 3: test substance in a 1:1 mixture (v/v) FCA/NaCl solution
Epicutaneous: test substance
- Control group I+II:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture (v/v) FCA/NaCl solution
Injection 2: corn oil
- Site: shoulder region (intradermal + epicutaneous)
- Frequency of applications: every 7 days
- Duration: Days 0-7
- Concentrations: intradermal 10%, epicutaneous 100%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Day 21
- Exposure period: 24 h
- Test groups: test substance
- Control group I: test substance
- Control group II: vehicle control is employed only in the induction treatment; no challenge with vehicle
- Site: left flank
- Concentrations: 100%
- Evaluation (hr after challenge): 24, 48 and 72 h
SCORING SYSTEM:
Skin reactions (erythema, eschar formation and edema) were evaluated according to the scheme presented in Table 1 under "Any other information on materials and methods incl. tables".
OTHER:
The highest concentration of test substance administered dermally in the preliminary test caused no irritation of the skin. In order to cause slight to moderate inflammation of the skin for the dermal induction, one day before the dermal administration (Day 6) all the test and control animals were sheared on the shoulder and treated with sodium dodecyl sulphate (10%). - Challenge controls:
- The control group is actually a challenge control.
- Positive control substance(s):
- not specified
- Remarks:
- ; according to the author, the reliability of the test system was checked at regular intervals (no details provided in study report).
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- induction: 0%; challenge: 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:
- induction: 10% and 100%; challenge: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- induction: 0%; challenge: 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:
- induction: 10% and 100%; challenge: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other: reliability was checked at regular intervals
- Group:
- positive control
- Remarks on result:
- other: No details in report given
Any other information on results incl. tables
Table 1. Results of the intradermal application (preliminary test).
Concentration (w/w) |
animal 1 E O |
animal 2 E O |
||
0.25 |
2 |
2 |
2 |
2 |
0.5 |
2 |
2 |
2 |
2 |
1.00 |
2 |
2 |
2 |
2 |
2.5 |
2 |
2 |
2 |
2 |
5.0 |
1 |
2 |
2 |
2 |
10.00 |
1 |
2 |
1 |
2 |
corn oil |
2 |
2 |
1 |
1 |
PRELIMINARY TEST
Dermal application
After 24, 48 and 72 h, no skin reaction was observed in the test animals in the concentration 2.5, 25 and 50% of the test substance. After 24 h very slight erythema and oedema were observed in 2/4 animals being fully reversible after 48 h.
MAIN TEST
- Bodyweight changes and systemic effects:
No toxic effects were observed in the treated animals during the observation period.
One animal died within 24 h after the dermal induction. Possibly, the animal was too strongly bandaged resulting in dyspnoea and death. Necropsy revealed a clear yellow liquid in the thorax and no further abnormal organ findings.
- Results of the intradermal induction:
One h after injection of FCA all test and control animals showed severe erythema and oedema. 11/20 test animals and 6/20 control animals showed injuries in the depth. 24 h later all animals showed severe erythema and oedema.
24 h after test substance injection all test animals showed slight erythema and oedema comparable to the control animals. Injection of test substance and FCA (1:1) induced moderate to strong erythema and moderate oedema. After 24 h strong erythema with deep injuries in 8/20 test animals and strong oedema were observed. Control animals injected with 50% FCA and corn oil showed 1 h after application well defined erythema and slight oedema. 24 h post application severe erythema with deep injuries (3/20) and strong oedema were observed.
- Results of the dermal induction:
Due to the use of SDS the shoulder region was reddened and swollen at Day 7. All test and control animals treated with FCA showed 49 h post application severe erythema with deep injuries and eschar formation and severe oedema. After 72 h the application sites of all animals were swollen and eschar formation was apparent. The animals treated with test substance in the vehicle showed scale formation at 49 and 72 h post application.
Animals treated with the test substance in FCA showed severe erythema with injuries in the depth and strong oedema at 49 and 72 h after application. The control animals showed comparable reaction at the application site.
- Results of the challenge application:
None of the test animals and none of the control animals showed a skin reaction 48 and 72 h post application.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
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