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EC number: 205-465-5 | CAS number: 141-17-3
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24 Oct - 27 Dec 2012
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study. No signature.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- (1992)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- (2008)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Version / remarks:
- (2003)
- Deviations:
- no
- 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:
- Bis(2-(2-butoxyethoxy)ethyl) adipate
- EC Number:
- 205-465-5
- EC Name:
- Bis(2-(2-butoxyethoxy)ethyl) adipate
- Cas Number:
- 141-17-3
- Molecular formula:
- C22H42O8
- IUPAC Name:
- bis(2-(2-butoxyethoxy)ethyl) adipate
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
- Strain: Crl:HA
- Source: Charles River, Sulzfeld, Germany
- Age at study initiation: approximately 4 weeks old
- Weight at study initiation: 315 - 366 g
- Housing: The animals were kept in groups in Terluran - cages on Altromin saw fibre bedding (preliminary test: lot no. 190612, main study: lot no. 290912) in a semi barrier in an air-conditioned room.
- Diet: autoclaved hay and Altromin 3122 maintenance diet for guinea pigs (preliminary test: lot no. 1114, main study: lot no. 0807), rich in crude fibre; ad libitum
- Water: tap water (drinking water, municipal residue control, microbiological controls at regular intervals); ad libitum
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: physiological saline 0.9% NaCl (B. Braun Melsungen, lot no. 121678081, expiry date: 03/2015) for intradermal induction I; vaseline (Euro OTC Pharma, lot no. 1105029-01, expiry date: 05/2014) for the challenge
- Concentration / amount:
- Induction: 5% intradermal, 100% epicutaneous
Challenge: 50%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: physiological saline 0.9% NaCl (B. Braun Melsungen, lot no. 121678081, expiry date: 03/2015) for intradermal induction I; vaseline (Euro OTC Pharma, lot no. 1105029-01, expiry date: 05/2014) for the challenge
- Concentration / amount:
- Induction: 5% intradermal, 100% epicutaneous
Challenge: 50%
- No. of animals per dose:
- - 3 (dose range finding study)
- 10 (test group), 5 (positive control group), 5 (negative control group) - Details on study design:
- RANGE FINDING TESTS:
For the justification of dose levels a preliminary test was performed.
- 1 animal was treated intradermally with concentrations of 2.5% and 5% of the test item (suspended with physiological saline 0.9% NaCl).
- 1 animal was treated topically with concentrations of 50% and 100% of the test item (suspended with vaseline) for 24 hours.
- 1 animal was treated topically with concentrations of 50% and 100% of the test item (suspended with vaseline) for 48 hours.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 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/physiological saline 0.9% NaCl
Injection 2: a 5% concentration of the test item in physiological saline 0.9% NaCl
Injection 3: a 5% concentration of the test item formulated in a 1:1 mixture (v/v) FCA/physiological saline 0.9% NaCl
Epicutaneous: 0.5 g of 100% test item
- Control group:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture (v/v) FCA/physiological saline 0.9% NaCl
Injection 2: 100% physiological saline 0.9% NaCl
Injection 3: a 50% (v/v) formulation of physiological saline 0.9% NaCl in a 1:1 (v/v) mixture FCA/physiological saline 0.9% NaCl
Epicutaneous: 0.5 g of vaseline
- Site: shoulder region
- Frequency of applications: every 7 days
- Duration: Days 0 - 8
- Concentrations: 5% intradermal, 100% epicutaneous
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 20
- Exposure period: 24 h
- Test groups: 0.5 g of 50% test item in vaseline and 0.5 g vaseline only
- Control group: 0.5 g of 50% test item in vaseline and 0.5 g vaseline only
- Site: left flank (test substance) and right flank (vehicle)
- Concentrations: 50%
- Evaluation (hr after challenge): 24 and 48 h
OTHER:
- The application area was not rinsed after challenge exposure. - Challenge controls:
- The control group is actually a challenge control.
- Positive control substance(s):
- yes
- Remarks:
- 2-Mercaptobenzothiazole: 2% in in cottonseed oil and 50% w/v formulation of 2-mercaptobenzothiazole in a 1:1 (v/v) mixture FCA/physiological saline 0.9% NaCl
Results and discussion
- Positive control results:
- - 24 h after removing the patch: erythema grade 2 in 2/5, erythema grade 1 in 3/5, oedema grade 1 in 2/5, eschar in 2/5 and desquamation in 3/5 positive control animals
- 48 h after removing the patch: erythema grade 1 in 5/5, eschar in 3/5 and desquamation in 5/5 positive control animals
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- intradermal induction: 5%; epicdermal challenge: 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: intradermal induction: 5%; epicdermal challenge: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- intradermal induction: 5%; epicdermal challenge: 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: intradermal induction: 5%; epicdermal challenge: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- intradermal induction: 0%; epicdermal challenge: 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: intradermal induction: 0%; epicdermal challenge: 50%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- intradermal induction: 0%; epicdermal challenge: 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: intradermal induction: 0%; epicdermal challenge: 50%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 25% positive control substance
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 25% positive control substance. No with. + reactions: 5.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 25% positive control substance
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 25% positive control substance. No with. + reactions: 5.0. Total no. in groups: 5.0.
Any other information on results incl. tables
Preliminary Test:
For each induction the highest concentration to cause mild-to-moderate skin irritation, but well tolerated systemically, was used.
Based on the results of this preliminary test, a concentration of 5% was chosen for the intradermal application of the main test and a concentration of 100% was selected for the dermal induction.
A concentration of 50% was found to be the highest dose which did not cause any signs of irritation after a topical treatment over a period of 24 hours and therefore was chosen for the challenge application in the main test.
Main Test:
All animals of both groups survived throughout the test period.
Signs of irritation during the induction:
Intradermal Induction I (24-hour reading):
- Injection site 1: erythema grade 1 in 5/5 negative control-, in 5/5 positive control- and 10/10 test animals, oedema grade 1 in 5/5 negative control-, in 5/5 positive control- and 10/10 test animals
- Injection site 2: erythema grade 1 in 1/5 positive control animals, oedema grade 1 in 1/5 positive control animals
- Injection site 3: erythema grade 1 in 1/5 negative control-, in 5/5 positive control- and 5/10 test animals, oedema grade 1 in 1/5 negative control-, in 5/5 positive control- and 5/10 test animals
Intradermal Induction I (48-hour reading):
- Injection site 1: erythema grade 1 in 5/5 negative control-, in 5/5 positive control- and 10/10 test animals, oedema grade 1 in 5/5 negative control-, in 5/5 positive control- and 10/10 test animals
- Injection site 2: no signs of irritation
- Injection site 3: erythema grade 1 in 1/5 negative control-, in 5/5 positive control and 5/10 test animals, oedema grade 1 in 1/5 positive control- and 1/10 test animals
Dermal Induction II (48-hour exposure, occlusive):
- Immediately after removing the patch: no signs of irritation in any of the test or control animals.
- 24 hours after removing the patch: no signs of irritation in any of the test or control animals.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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