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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 700-816-3 | CAS number: 9041-08-1
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- Study initiation date: 29 september, 2000 - Experimental observations completed on 8 December, 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP, guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- other: Annex IV C to 96/54/EC Commission directive
- Qualifier:
- according to guideline
- Guideline:
- other: 91/507/EC Commission directive
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Heparin, sodium salt
- Cas Number:
- 9041-08-1
- IUPAC Name:
- Heparin, sodium salt
- Details on test material:
- - Name of test material (as cited in study report): Heparin sodique
- Physical state: white amorphic powder
- Purity: 100%
- Lot/batch No.: 0015865
- Storage condition of test material: at room temperature (10 to 30 °C) in the dark
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: D hall Ltd, Burton
- Age: Based on information from the supplier the guinea pigs were approximately 6 to 8 weeks old on Day 1.
- Body Weight: Animals in the main study were in a body weight range from 454 to 558g prior to dosing on Day 1.
- Housing: guinea pigs were accomodated in suspended polypropylene cages (six per battery) with open tops, solid floors and stainless steel mesh front panels (providing minimum dimensions of 61x81x25 cm). Each cage held up to 5 animals and was relined with a whitewood bedding, Grade 10 Woodflakes from Datesand Ltd, Brooklands, three times each week. Each batch of bedding had been analysed for specific constituents.
- Diet : SQC FD1 (pelleted) diet from Special Diets Services Ltd freely available
- Water (e.g. ad libitum): via water bottles
- Acclimation period: up to 22 days
No contaminant were expected to be present in diet or water.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25 °C
- Humidity (%): 40-70%
- Air changes (per hr): 14 air changes/h
- the rooms were illuminated by fluorescent strip-lights for twelve hours daily.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: vaseline
- Concentration / amount:
- Intradermal injection: 10% m/v Heparin sodique in purified water and/or adjuvant
Topical induction: 50% m/m Heparin sodique in vaseline
Challenge application: 20 and 40% m/m Heparin sodique in vaseline
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: vaseline
- Concentration / amount:
- Intradermal injection: 10% m/v Heparin sodique in purified water and/or adjuvant
Topical induction: 50% m/m Heparin sodique in vaseline
Challenge application: 20 and 40% m/m Heparin sodique in vaseline
- No. of animals per dose:
- 10 treated animals and 5 controls
- Details on study design:
- MAIN STUDY
INDUCTION PHASE-intradermal injection
The dorsum overlaying the scapulae of each guinea pig was clipped on the day before treatment commenced. The area was confirmed to be free from injury or irritation. On Day 1 three paired intradermal injections (approximately 0.1 ml per site) were placed in single rows parrallel to and on either side of the dorsal mid-line of each guinea pig such that the anterior and posterior injection sites marked the corners of an approximate 20 x 40 mm area. The middle injection sites were positioned close to the anterior sites. The concentration of test article selected after the first screen was administered as follows:
Anterior: Test group: FCA / Control group: FCA
Middle: Test group:Heparin sodique, 10% m/v in purified water / Control group: purified water
Posterior: Test group:Heparin sodique, 10% m/v in FCA / Control group: 50% v/v purified water in FCA
Irritation or other dermal changes at the injection site were recorded by group on Day 2.
INDUCTION PHASE- topical application
On Day 7 the areas of dorsum denuded for the first phase of induction were clipped. Since the formulation selected was non-irritating in the screening test, the denunded areas were subject to application of 10% m/m sodium lauryl sulphate in petrolatum on Day 7. A dose of approximately 0.4 ml was rubbed into the dorsum using a gloved finger. This procedure is intended to produce a mild irritation of the skin to be treated on the following day. On Day 8 each dorsum was shaved. Approximately three hours later the area of skin including the intradermal injection sites was subject to application of a 25 x 50 mm lint pad, loaded with approximately 2 ml of 50% mm Heparin sodique in vaseline (test animals) or vaseline alone (control group). Occlusion of the treated skin was effected by successive layers of Blenderm and elasticated bandage. The dressings remained in place for approximately 48 hours. The treated areas of skin were washed with water. Irritation or other dermal changes at sites of occluded topical application were recorded by group on Day 11.
CHALLENGE PHASE
Both flanks of all guinea pigs were clipped on Day 21 and shaved to remove hair stubble on Day 22. Approximately two hours later a lint pad, approximately 25 x 25 mm, loaded with approximately 1 ml 40% m/m Heparin sodique in vaseline was applied to the left flank of each animal. A second concentration 20% m/m Heparin sodique in vaseline was similarly applied to the right flank. The pads were kept in place by successive layers of Blenderm and elasticated bandage. The dressings were removed approximately 24 hours after application and the treated areas of skin were washed with arachis oil. Challenge site locations were marked with indelible ink immediately after the washing procedure.
The challenge sites were reshaved approximetaly 20 hours after removal of the dressings. Dermal responses to challenge were assessed approximately 24 and 48 hours after removal of the dressings. Responses to challenge were recorded individually. - Positive control substance(s):
- yes
- Remarks:
- The strain of guinea pigs selected for this study has been subject to regular (6 monthly) testing to confirm its susceptibility to a moderate skin sensitizer, 2-mercaptobenzothiazole
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 40%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 40%. No with. + reactions: 1.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 20%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 20%. No with. + reactions: 1.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 40%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- Slight erythema observed for one animal and desquamation observed for 2 animals. Inconclusive result for one animal, negative for all 9 other animals.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 40%. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: Slight erythema observed for one animal and desquamation observed for 2 animals. Inconclusive result for one animal, negative for all 9 other animals..
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 20%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- Slight erythema observed for one animal and desquamation observed for 3 animals. Inconclusive result for one animal, negative for all 9 other animals.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 20%. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: Slight erythema observed for one animal and desquamation observed for 3 animals. Inconclusive result for one animal, negative for all 9 other animals..
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 40%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- Desquamation observed for 1 animal.
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 40%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: Desquamation observed for 1 animal..
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 20%
- No. with + reactions:
- 1
- Total no. in group:
- 5
- Clinical observations:
- Slight erythema observed for one animal and desquamation observed for 1 animal.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 20%. No with. + reactions: 1.0. Total no. in groups: 5.0. Clinical observations: Slight erythema observed for one animal and desquamation observed for 1 animal..
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 40%
- No. with + reactions:
- 2
- Total no. in group:
- 5
- Clinical observations:
- Slight erythema observed for 2 animals and desquamation observed for 4 animals.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 40%. No with. + reactions: 2.0. Total no. in groups: 5.0. Clinical observations: Slight erythema observed for 2 animals and desquamation observed for 4 animals..
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 20%
- No. with + reactions:
- 3
- Total no. in group:
- 5
- Clinical observations:
- Slight erythema observed for 3 animals and desquamation observed for all 5 animals.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 20%. No with. + reactions: 3.0. Total no. in groups: 5.0. Clinical observations: Slight erythema observed for 3 animals and desquamation observed for all 5 animals..
Any other information on results incl. tables
One animal from the test group was found dead on day 2. No cause of death was established. No other clinical observations of ill heath or toxicity were noted during the study.
All guinea pigs gained weight over the course of the experimental phase.
Intradermal injection: Slight or well defined erythema was noted at the anterior and posterior injection (treated with Freund's Complete Adjuvant emulsion FCA) sites for both test and control animals. No erythema was observed at the middle injection site in test animals receiving 10% m/v heparin sodique in purified water nor at the midlle injection site in control animals receiving purified water alone.
Topical application: No more than slight erythema was apparent in test animals following application of 50% m/m Heparin sodique in vaseline. No erythema was apparent at the topical application sites in the control guinea pigs.
Challenge phase: Slight erythematous reactions were seen at one of both treatment sites in the control group for three of the animals. Within 48 hours of the challenge application, all control animals had areas of desmaquation - this is commonly observed following occlusive bandaging of the skin and was not considered to be indicative of the test article irritation or sensitisation. In the test group similar reactions were seen but at a lower incidence. None of the animals developped reactions that were clearly more marked than those noted in the control group. The persistence of the reaction at one site was considered indicative of possible contact sensitivity but the individual result was deemed to be equivocal.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The results from the challenge procedure indicated that no animals gave a positive response indicative of delayed contact hypersensitivity, the response for one animal was inconclusive.
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.