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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 947-398-0 | CAS number: -
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22 Oct 2001 to 19 Nov 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- 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
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- 29 December 1992
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Currently no LLNA study is available for assessment. The Guinea Pig Maximization Test (GPMT) has been carried out as an animal test to predict human sensitization for over a decade and is recommended by international test guidelines such as OECD.
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
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- - Name of the test item (as cited in report): Axol C62
- Batch No.: 14 EG 13
- Expiration date of the lot/batch: March 2002
- Purity test date: 100%
- Appearance: Fine ivory-coloured powder
- Storage condition of test material: Ambient, protected from light
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, Postfach 11 61, 33178 Borchen, Germany
- Weight at study initiation: 597 - 701 g (males) and 468 - 592 (females)
- Housing: Before animals arrived, the study room and cages were cleaned and disinfected. During the study, the room and cages were cleaned at regular intervals. The guinea pigs were kept in collective housing up to a maximum of 5 animals per cage in a battery of cages, equipped with a paper disposal system.
- Diet: The animals received "2040 Teklad Global Guinea Pig Diet" (pelleted diet, batch no. 1-1169) produced by Harlan Teklad, Shaw's farm, Blackthorn Bicester, Oxon, OX6 OTP, England, offered ad libitum
- Water: Tap water as for human consumption was continuously available ad libitum via drinking nipples.
- Acclimation period: 26 days (range finding test), 30 days (main test)
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 30 - 70%
- Air changes (per hr): 16 times per hour
- Photoperiod: 12/12 with light on at 07:00 a.m.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- 50% FCA
- Route:
- intradermal
- Vehicle:
- other: water with Tween 80
- Concentration / amount:
- 5% test substance
- Route:
- intradermal
- Vehicle:
- other: water with Tween 80/FCA
- Concentration / amount:
- 5% test substance
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- 50% FCA (Control)
- Route:
- intradermal
- Vehicle:
- other: water with Tween 80
- Concentration / amount:
- 0% (Control)
- Route:
- intradermal
- Vehicle:
- other: water with 50% Tween 80 (v/v) in FCA
- Concentration / amount:
- 0% (Control)
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: vaseline
- Concentration / amount:
- 50% test substance
- Day(s)/duration:
- 48 h
- Adequacy of induction:
- other: non-irritant substance, but pretreated with 10% SLS
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: vaseline
- Remarks:
- Control
- Concentration / amount:
- 0% (Control)
- Day(s)/duration:
- 48 h
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.5 g
- Day(s)/duration:
- 24 h
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Remarks:
- (Control)
- Concentration / amount:
- 0.5 g
- Day(s)/duration:
- 24 h
- No. of animals per dose:
- 10 test group and 5 control group
- Details on study design:
- RANGE FINDING TEST
Two animals (1 male, 1 female) were used in the range finding test. The range finding test was performed to determine the concentrations of the test article to be used in the main test. For the intradermal injection, the test article was diluted with aqua ad iniectabilia (containing 1 drop of Tween 80) and Freund's complete adjuvant (FCA; batch no. 20K8933; SIGMA, Deisenhofen) to a final concentration of 5.0 %. Two animals were employed, skin reactions being recorded 48 h after treatment.
For the dermal application, the test article was used 50 % in vaselin (batch no. 419496/144700, Fluka AG, CH-Buchs). A closed patch exposure was effected by means of an occlusive bandage using Hill-Top Chambers (Hill Top, Cincinnati, USA) and nonirritating tape Elastoplast@ (Beiersdorf AG, Hamburg), which enveloped the whole animal's trunk. Two animals were employed and skin reactions were recorded 48 h post application.
MAIN STUDY
On the basis of the results of the range finding test, the concentration of 5 % of the test article was considered to be suitable for intradermal injection and the concentration of 50 % of the test article for dermal application.
A. INDUCTION EXPOSURE
In each test animal, three pairs of intradermal injections (0.1 ml) were made in the clipped intrascapular region on either side of the spine. Seven days later, the previous injection sites were covered occlusively for 48 h with a patch carrying the test article or, in control animals, the control article. Since the 50 % test article 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 article to induce a mild inflammation.
B. CHALLENGE
Both control and test animals were subjected to a challenge exposure 14 days after the second stage of the induction. The challenge test was performed on a 5 x 5 cm clipped skin area on each flank. The test article was applied to the left flank and the control article petrolatum to the right in a volume of 0.5 g using the patch technique. In each case, the duration of the exposure was 24 h under an occlusive dressing.
OBSERVATIONS
24 and 48 h after patch removal the appearance of the challenge skin sites was observed and skin responses were graded on the basis of the classification system according to draize. The animals were weighed before treatment and at the end of the study. All findings were recorded with respect to duration and severity on special report forms. - Positive control substance(s):
- yes
- Remarks:
- 4-aminobenzoic acid ethyl ester (benzocaine)
Results and discussion
- Positive control results:
- The sensitivity of the test system and the reliability of the experimental technique is assessed at least every six months by use of "4-aminobenzoic acid ethyl ester (benzocaine)" which is known to induce skin sensitisation in guinea pigs. This test was conducted as a Magnusson & Kligman test accorcling to the OECD Guideline for Testing of Chemicals, OECD 406, 17 July 1992 and to the EEC Directive 92/69/EEC, 31 July 1992. The latest test before this study was with acceptable levels of responses to this substance.
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
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 50 %
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 50%
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 10 %
- No. with + reactions:
- 2
- Total no. in group:
- 10
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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.