Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 807-654-3 | CAS number: 1627851-18-6
Toxicological information
Skin sensitisation
Currently viewing:
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 05 Jun 2012 - 30 Aug 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Federal Republic of Brazil, Ministry of Development, Industry and Foreign Trade, National Institute of Metrology, Standardization and Industrial Quality
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The experimental study was performed in Brazil. At that moment there were no viable alternative, in vitro or otherwise, to the use of live animals was accepted by the relevant supervisory government agencies.
Test material
- Reference substance name:
- (2R,3R,4S,5S,6R)-2-(heptyloxy)-6-(hydroxymethyl)oxane-3,4,5-triol; (2R,3R,4S,5S,6R)-2-{[(2R,3S,4S,5R,6R)-6-(heptyloxy)-3,4,5-trihydroxyoxan-2-yl]methoxy}-6-(hydroxymethyl)oxane-3,4,5-triol; (2R,3R,4S,5S,6R)-2-{[(2R,3S,4S,5R,6R)-6-{[(2R,3S,4S,5R,6R)-6-(heptyloxy)-3,4,5-trihydroxyoxan-2-yl]methoxy}-3,4,5-trihydroxyoxan-2-yl]methoxy}-6-(hydroxymethyl)oxane-3,4,5-triol
- EC Number:
- 807-654-3
- Cas Number:
- 1627851-18-6
- Molecular formula:
- (C6H10O5)nC7H16O, n - number of D-glucopyranose units
- IUPAC Name:
- (2R,3R,4S,5S,6R)-2-(heptyloxy)-6-(hydroxymethyl)oxane-3,4,5-triol; (2R,3R,4S,5S,6R)-2-{[(2R,3S,4S,5R,6R)-6-(heptyloxy)-3,4,5-trihydroxyoxan-2-yl]methoxy}-6-(hydroxymethyl)oxane-3,4,5-triol; (2R,3R,4S,5S,6R)-2-{[(2R,3S,4S,5R,6R)-6-{[(2R,3S,4S,5R,6R)-6-(heptyloxy)-3,4,5-trihydroxyoxan-2-yl]methoxy}-3,4,5-trihydroxyoxan-2-yl]methoxy}-6-(hydroxymethyl)oxane-3,4,5-triol
- Test material form:
- other: liquid, not further specified
- Details on test material:
- - Name of test material (as cited in study report): only trade name given
- Physical state: liquid
- Analytical purity: 78.7% (a.i.) (information sponsor)
- Lot/batch No.: 2663 JG5
- Expiration date of the lot/batch: May 2013
- Storage condition of test material: stable at room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: ANILAB-SP, Brazil
- Age at study initiation: 10 weeks
- Weight at study initiation: 404-556 g
- Housing: animals were housed in groups of 5 in 99 x 79 x 28 cm polypropylene cages with autoclaved wood shavings as bedding.
- Diet: pelleted commercial diet ‘Nuvilab Cobaias 6001’, ad libitum
- Water: filtered drinking water enriched with ascorbic acid (300 mg/L), ad libitum
- Acclimation period: 12 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22.9
- Humidity (%): 50-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 05 Jun 2012 To: 29 Jun 2012
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: deionised water
- Concentration / amount:
- Induction, intradermal: 3.9% v/v
Induction, epicutaneous: 78.7% v/v (undiluted)
Challenge: 19.7% v/v
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: deionised water
- Concentration / amount:
- Induction, intradermal: 3.9% v/v
Induction, epicutaneous: 78.7% v/v (undiluted)
Challenge: 19.7% v/v
- No. of animals per dose:
- 10 (controls), 20 (in test group)
- Details on study design:
- RANGE FINDING TESTS:
A. Intradermal induction pilot study in two animals
- Test concentrations: 0.8, 1.6, 2.4, 3.1 and 3.9% a.i.
- Results: 3.9% of the test substance was chosen for the main study, since it was well tolerated systemically and the highest concentration causing slight to mild skin irritation in the animals 24 h after application.
B. Epicutaneous induction and challenge pilot study in two animals (tested on the same animals as in the intradermal induction pilot study)
Test concentrations: 19.7 and 78.7% a.i. (undiluted) (animal 1); 39.4 and 59% a.i. (animal 2)
-Results: 1 mL of the undiluted test substance was chosen for the topical induction because it was well tolerated systemically and the highest concentration causing slight to mild skin irritation in the animals 24 h after application. One mL of the test substance at 19.7% was chosen for challenge, since it was well tolerated systemically and the highest dose causing no skin reaction.
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 (v/v) mixture FCA/deionised water
Injection 2: test substance at 3.9% a.i in deionised water
Injection 3: 3.9% a.i. formulation of the test substance on a 1:1 (v/v) mixture FCA/deionised water
Epicutaneous: undiluted test substance (78.7% a.i.)
- Control group:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 (v/v) mixture FCA/deionised water
Injection 2: deionised water
Injection 3: 50% v/v formulation of vehicle (deionised water) on a 1:1 (v/v) mixture FCA/deionised water
Epicutaneous: sham exposure (empty patches)
- Site: shoulder region (intradermal and epicutaneous)
- Frequency of applications: 7 days (Day 0 and Day 7)
- Duration: Days 0-9
- Concentrations: intradermal 3.9% a.i., epicutaneous 78.7% a.i. (undiluted)
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: 21
- Exposure period: 24 h
- Test groups: test substance in deionised water
- Control group: test substance in deionised water
- Site: right flank
- Concentrations: 19.7% a.i.
- Evaluation (hr after challenge): 48 and 72 (i.e. 24 and 48 h after removal of patches) - Challenge controls:
- The control group actually serves the purpose of a challenge control. No true challenge control included.
- Positive control substance(s):
- yes
- Remarks:
- alpha-hexylcinnamaldehyde
Results and discussion
- Positive control results:
- The reliability check with the positive control substance alpha-hexylcinnamaldehyde (85%, technical grade) was performed in April 2012. In this study, alpha-hexylcinnamaldehyde (intradermal induction: 5% v/v; topical induction: 100% v/v; challenge: 25% v/v) induced discrete or patchy erythema (grade 1) and moderate and confluent erythema (grade 2) in 45% of the treated animals that persisted at both 48 and 72 h observation time points after challenge application. Therefore, treatment with the positive control alpha-hexylcinnamaldehyde met the reliability criteria for the GPMT (≥ 30% positive responses).
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Induction: 0%; Challenge: 19.7% a.i.
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: Induction: 0%; Challenge: 19.7% a.i.. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Induction: 3.9% a.i.; Challenge: 19.7% a.i.
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: Induction: 3.9% a.i.; Challenge: 19.7% a.i.. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- Induction: 5% v/v; Challenge: 25% v/v
- No. with + reactions:
- 9
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: positive control. Dose level: Induction: 5% v/v; Challenge: 25% v/v. No with. + reactions: 9.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- Induction: 0%; Challenge: 19.7% a.i.
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: Induction: 0%; Challenge: 19.7% a.i.. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- Induction: 3.9% a.i.; Challenge: 19.7% a.i.
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: Induction: 3.9% a.i.; Challenge: 19.7% a.i. . No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- positive control
- Dose level:
- Induction: 5% v/v; Challenge: 25% v/v
- No. with + reactions:
- 11
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: positive control. Dose level: Induction: 5% v/v; Challenge: 25% v/v. No with. + reactions: 11.0. Total no. in groups: 20.0.
Any other information on results incl. tables
Only treated animals presented skin reactions (moderate and confluent erythema) in the intradermal induction application. However, the observed skin reactions were due to skin irritation rather than sensitisation. Treated and control animals presented no skin reactions in the topical induction and challenge applications. No behavioral alterations were observed in the treated animals.
Conclusion:
The epidermal application of the test substance using deionised water as vehicle did not cause skin sensitisation in guinea pigs according to the Magnusson & Kligman Test Method.
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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
