Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Diss Factsheets
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: 294-601-7 | CAS number: 91744-39-7
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
![](https://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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.
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)