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EC number: 941-899-8 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- None
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- The test article name was completed. In addition to the highest non-irritating test substance concentration a lowest test substance concentration was applied in the second challenge.
- Principles of method if other than guideline:
- Guideline followed
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Data from a reliable in vivo test conducted before the enforcement of Commission Regulation (EU) 640/2012 of 06 July 2012 amending, for the purpose of its adaptation to technical progress, Regulation (EC) No 440/2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) are available.
Test material
- Reference substance name:
- Reaction mass of 1,7-Naphthalenedisulfonic acid, 4-[[3-[(2-bromo-1-oxo-2-propen-1-yl)amino]benzoyl]amino]-6-[2-[5-[(2-bromo-1-oxo-2-propen-1-yl)amino]-2-sulfophenyl]diazenyl]-5-hydroxy-, sodium salt (1:3) and Trisodium 6-[{5-[(2-bromoacryloyl)amino]-2-sulfonatophenyl}diazenyl]-4-({3-[(2,3-dibromopropanoyl)amino]benzoyl}amino)-5-hydroxynaphthalene-1,7-disulfonate
- EC Number:
- 941-899-8
- Cas Number:
- 1625603-53-3
- Molecular formula:
- C29H18Br2N5Na3O13S3 . C29H19Br3N5Na3O13S3
- IUPAC Name:
- Reaction mass of 1,7-Naphthalenedisulfonic acid, 4-[[3-[(2-bromo-1-oxo-2-propen-1-yl)amino]benzoyl]amino]-6-[2-[5-[(2-bromo-1-oxo-2-propen-1-yl)amino]-2-sulfophenyl]diazenyl]-5-hydroxy-, sodium salt (1:3) and Trisodium 6-[{5-[(2-bromoacryloyl)amino]-2-sulfonatophenyl}diazenyl]-4-({3-[(2,3-dibromopropanoyl)amino]benzoyl}amino)-5-hydroxynaphthalene-1,7-disulfonate
- Test material form:
- other: solid
- Details on test material:
- - Name of test material (as cited in study report): LANASOL ROT 2G ROH TROCKEN (FAT92348/A)
- Physical state: Red Powder
- Analytical purity: active ingredients: approx. 100 %
- Lot/batch No.: 279291.26
- Storage condition of test material: at room temperature
Constituent 1
- Specific details on test material used for the study:
- None
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Himalayan
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: BRL, Biological Research Laboratory Limited
- Age at study initiation: 6 - 8 weeks
- Weight at study initiation: 298 -395 g
- Housing: Individually in Makrolon type - 3 cages (Size: 22 x 37 x 15 cm) with standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz).
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 + or - 3 °C
- Humidity (%): 40 - 70 %
- Air changes (per hr): 10 to 15 air changes / hour
- Photoperiod (hrs dark / hrs light): 12 hrs artificial fluorescent light and 12 hrs dark
IN-LIFE DATES: From: 26 Jan 1993 To: 27 April 1993
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 5%
- Day(s)/duration:
- Day 0
- Adequacy of induction:
- highest technically applicable concentration used
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: vaselinum album
- Concentration / amount:
- 25%
- Day(s)/duration:
- Day 7
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
Challengeopen allclose all
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: vaselinum album
- Concentration / amount:
- 25%
- Day(s)/duration:
- Two weeks after the epidermal induction application
- Adequacy of challenge:
- highest non-irritant concentration
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: vaselinum album
- Concentration / amount:
- 25 and 15%
- Day(s)/duration:
- Two weeks after the first challenge
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Control group: 10 female albino guinea pigs
Test group: 20 female albino guinea pigs - Details on study design:
- RANGE FINDING TESTS:
Intradermal Injections:
Intradermal injections (0.1ml/site) were made into the clipped flank of two guinea-pigs at concentrations of 5, 3 and 1 % of the test article in physiological saline. The resulting dermal reactions were assessed 24 hours later.
Epidermal application:
Patches of filter paper (2 X 2 cm) were saturated with concentrations of 5, 10, 15 and 25 % of the test article in vaselinum album and applied to the clipped and shaved flanks of each of the four guinea-pigs. The patches were covered by a strip of aluminium foil and firmly secured by elastic plaster wound round the trunk and covered with impervious adhesive tape. This procedure ensured the intensive contact of the test article. The dressing were removed after an exposure period of 24 hours and the reaction sites were assessed for erythema and edema on a numerical basis according to the scale described above. Further examination of the sites were performed 24 and 48 hours after removal of the dressing.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: 24 hr
- Test groups: 1) Freund's complete adjuvant 50:50 with physiological saline.
2) The test article, diluted to 5 % in physiological saline.
3) The test article diluted to 5 % by emulsion in a 50:50 mixture of Freund's complete adjuvant and physiological saline.
- Control group: 1) Freund's complete adjuvant 50:50 with physiological saline.
2) physiological saline.
3) Freund's complete adjuvant 50:50 with physiological saline.
- Site: right and left flanks of the Guinea pig.
- Frequency of applications: 1
- Duration: 24 hr
- Concentrations: 5 %
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: 2 weeks
- Exposure period: 24 hr
- Test groups: 25 % test article in vaselinum album
- Control group: Vaselinum album
- Site: Left and right flank
- Concentrations: 25 %
- Evaluation (hr after challenge): 24 hr - Challenge controls:
- Epidermal application: The guinea-pigs of the control group were treated as described above with the omission of test article (vaselinum album only).
Intradermal injection:
1) Freund's complete adjuvant 50:50 with physiological saline.
2) physiological saline.
3) Freund's complete adjuvant 50:50 with physiological saline. - Positive control substance(s):
- yes
Results and discussion
- Positive control results:
- The intradermal induction was performed with a dilution at 5% in acetone. For the induction period and challenge procedure a 25& dilution of 2-MERCAPTOBENZOTHIAZOL in acetone was used. This concentration was found in a pretest to be the highest primary not-irritant concentration.
According to the results observed it is considered that the known allergen 2-MERCAPTOBENZOTHIAZOL possess a moderate skin sensitizing potential in the guinea pig strain used (Ibm: GOHI; SPF-quality guinea pigs (synonym: Himalayan spotted); BRL, Biological Research Laboratories Ltd., CH-4414 Füllinsdorf)
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- other: 1st reading after first challenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 2
- Total no. in group:
- 19
- Clinical observations:
- No adverse effects
- Remarks on result:
- other: One test animal was found dead at test day 14, six days after the epidermal induction application.
- Key result
- Reading:
- other: 2nd reading after first challenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 2
- Total no. in group:
- 19
- Clinical observations:
- No adverse effects
- Remarks on result:
- other: One test animal was found dead at test day 14, six days after the epidermal induction application.
- Key result
- Reading:
- other: 1st reading after second challenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25% on POSTERIOR RIGHT FLANK and 15% on ANTERIOR RIGHT FLANK
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Clinical observations:
- No clinical signs
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- other: 2nd reading after second challenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25% on POSTERIOR RIGHT FLANK and 15% on ANTERIOR RIGHT FLANK
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Clinical observations:
- No clinical signs
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- This test article is considered not to be a sensitizer.
- Executive summary:
This study was performed to assess the allergenic potential of LANASOL ROT 2G ROH TROCKEN (FAT 92'348/A) in albino guinea pigs by following OECD Test guideline 406 and in accordance to GLP principles.
Ten females were used as control group and 20 females were used as test group.
In this study 11 % of the animals were positive after the first challenge when treated with a non-irritant test substance concentration of 25%. After the second challenge no skin reactions were observed in the animals treated with a 25 % and 15 % test substance concentration.
Hence, according to EEC (European Economic Community) classification criteria described in guidelines 91/325/EEC (EC Official Journal Nr. L 180, July 08, 1991), this test article is considered not to be a sensitizer.
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