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EC number: 294-601-7 | CAS number: 91744-39-7
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2001-10-22 to 2001-11-19
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 17. July 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- EEC Directive 92/69/EEC, Annex V, Test B6, 29. December 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- OECD Guideline 429 for LLNA method was not available yet by the time the study was conducted
Test material
- Reference substance name:
- Glycerides, C16-18 mono-, di- and tri-, hydrogenated, citrates, sodium salts
- EC Number:
- 294-601-7
- EC Name:
- Glycerides, C16-18 mono-, di- and tri-, hydrogenated, citrates, sodium salts
- Cas Number:
- 91744-39-7
- Molecular formula:
- Molecular formula cannot be given as substance is a mixture.
- IUPAC Name:
- Glycerides, C16-18 mono-, di- and tri-, hydrogenated, citrates, sodium salts
- Details on test material:
- - Chemical name: glycerocitric acid-/-fatty acid ester
- Physical state: fine, ivory-coloured powder
- Analytical purity: 100 % a.i.
- Impurities (identity and concentrations): no data
- Lot/batch No.: 14 EG 13
- Expiration date of the lot/batch: March 2002
- Storage condition of test material: ambient, protected from light
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright white, HsdPoc:DH
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, 33178 Borchen, Germany
- Age at study initiation: no data
- Weight at study initiation:at arrival: 300 - 350 g; main test: males: 597 - 701 g, females. 468 - 592 g
- Housing: collective housing up to a maximum of 5 animals per cage in a battery of cages, equipped with a paper disposal system
- Diet: ad libitum, 2040 Teklad Global guinea pig diet
- Water: ad libitum, tap water as for human consumption
- Acclimation period: 26 days (range finding); 30 days (main test)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30 - 70
- Air changes (per hr): about 16 times/hour
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark with light on at 7:00 a.m.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: water, containing one drop of Tween 80
- Concentration / amount:
- Range finding test:
- intradermal: 5 %
- dermal: 50 %
Main test:
- intradermal induction: 5 %
- dermal induction 50 %
- challange exposure: 50 %
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: water, containing one drop of Tween 80
- Concentration / amount:
- Range finding test:
- intradermal: 5 %
- dermal: 50 %
Main test:
- intradermal induction: 5 %
- dermal induction 50 %
- challange exposure: 50 %
- No. of animals per dose:
- Range finding test: 1 male and 1 female (5 % , 50 %)
Main test: 5 males and 5 females, 5 control animals (3 males, 2 females) - Details on study design:
- RANGE FINDING TESTS:
Intradermal injection:
Test substance was diluted with aqua ad injectabilia (containing one drop of Tween 80) and Freund´s complete adjuvant (FCA, batch no. 20K8933, Sigma, Deisenhofen, Germany) to a final concentration of 5.0 %. Two animals were employed, skin reactions being recorded 48 h after treatment.
Dermal application:
Test substance was used 50 % in vaseline (batch no. 419496/144700, Fulka AG, Buchs, Switzerland). A closed patch exposure was effected by means of an occlusive bandage using Hill-Top Chambers (Hill Top, Cincinnati, USA), and non-irritating tape Elastoplast (Beiersdorf AG, Hamburg, Germany), which enveloped 48 h post application.
MAIN STUDY
A. INDUCTION EXPOSURE
First stage (day 0)
- No. of exposures: 3 pairs of intradermal injections (0.1 ml) in each test animal
- Test groups:
1. FCA 50 % (v/v) diluted in aqua ad injectabilia
2. test substance 5 % in aqua ad injectabilia with Tween 80
3. test substance 5 % in aqua ad injectabilia with Tween 80/FCA
- Control group:
1. FCA 50 % (v/v) diluted in aqua ad injectabilia
2. Aqua ad injectabilia with Tween 80
3. Aqua ad injectabilia with Tween 80 50 % (v/v) diluted in FCA
- Site: clipped intrascapular region on either side of the spine
Second stage (day 7):
- Pretreatment: 10 % sodium lauryl sulfate (SLS) in vaseline 24 h before application of the test article
- Concentration: 50 % test substance in vaseline
- Exposure period: 48 h
- Site: The previous injection sited were covered occlusively with a patch carrying the test substance or, in control animals, the control article
- Rationale for pretreatment: Since the 50 % test substance formulation was non-irritating after dermal application in the range finding test, the skin area was reclipped and pretreated with 10 % sodium lauryl sulfate (SLS) in vaseline 24 h before application of the test substance to induce a mild inflammation.
B. CHALLENGE EXPOSURE (day 21)
- Day(s) of challenge: 14 days after second stage of induction
- Exposure period: 24 h
- Exposure: occlusive: closed patch exposure was effected by means of an occlusive bandage using Hill-Top Chambers (Hill Top, Cincinnati, USA), and non-irritating tape Elastoplast (Beiersdorf AG, Hamburg, Germany), which enveloped the whole animal´s trunk)
- Site: 5 x 5 cm clipped skin area on each flank. Test substance was applied to the left flank, and the control article to the right flank
- Volume of test substance and control article: 0.5 g
- Concentrations: 50 %
- Control group: control article: petrolatum
- Evaluation (hr after challenge): after 24 and 48 h
- Classification system for skin reactions: according to Draize
OTHER:
- The animals were weighed before treatment and at the end of the study.
Positve control (reliability check):
- The sensitivity of the test system and the reliability of the experimental technique was assessed at least every six month. 4-aminobenzoic acid ethyl ester (benzocaine, Lot-no.: 128H1235, concentration 10 and 50 % in vaseline) is known to induce skin sensitisation in guinea pigs. The test was conducted as a Magnusson und Kligman test according to OECD 406, 17 July 1992 and to the EEC Directive 92/69/EEC, 31 July 1992. - Positive control substance(s):
- yes
- Remarks:
- 4-aminobenzoic acid ethyl ester (benzocaine) periodically tested
Results and discussion
- Positive control results:
- Periodically checks of the sensitivity of the test system and the reliability of the experimental technique performed. According to the maximisation scheme of Magnusson and Kligman, the positive control article 4-aminobenzoic acid ethyl ester (benzocaine) was classified as a mild sensitiser at the concentration of 10 % , referring to an independent experiment (22 August to 15 September 2001)
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
- Reading:
- other: 1st and 2nd reading
- Group:
- positive control
- Remarks on result:
- not measured/tested
Any other information on results incl. tables
Range finding test:
Intradermal injection: No skin reactions were observed after intradermal injection of the test substance at a concentraton of 5 %.
Dermal application: No skin reactions were observed after dermal application of the test substance at a concentraton of 50 %.
Main test:
There were no skin reactions after the dermal application in the induction phase. No allergic skin reactions were observed in the test animals after the challange exposure 24 and 48 h after patch removal. No findings were observed in control animals.
The sensitisation rate was determined 24 and 48 h after patch removal and was 0 % in the test animal in each case.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- No allergic skin reactions occurred in test or control animals 24 and 48 h after the end of the challenge procedure. The sensitisation rate was 0 %
- Executive summary:
In a dermal sensitization study with CAS 91744-39-7 (100 % a.i.), 10 Pirbright white guinea pigs (5 males, 5 females) were tested using the MAXIMATION TEST method of Magnusson und Kligman according to OECD Guideline 406. The sensitivity of the test system was periodically assessed with the positive control 4-Aminobenzoic acid ethyl ester (benzocaine).
Concentrations used for intradermal and dermal induction were 5 % in water and 50 % in vaseline, respectively. Since the 50 % test substance formulation was non-irritating after dermal application in the range finding test, the skin area was pretreated with 10 % sodium lauryl sulfate in vaseline 24 h before dermal induction treatment to induce a mild inflammation. Challenge exposure concentration was 50 % in vaseline.
No allergic skin reactions occurred in test or control animals 24 and 48 h after the end of the challenge procedure. The sensitisation rate was 0 %.
In this study, the test substance is not a dermal sensitizer.
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