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EC number: 212-485-8 | CAS number: 822-06-0
- 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:
- 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- - no range finding for the induction; the second induction on Day 7 was performed by intradermal injection; two challenges were performed on Day 21 and Day 35 by topical application under occlusive conditions for 6 hours each
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The guinea pig maximisation test (GPMT) was an adequate in vivo skin sensitisation test at the time of performance in 1982. In addition, the GPMT is a challenge assay and more appropriate for determining skin sensitisation of highly reactive substances like diisocyanates. For this substance group the LLNA often provides over-predictive results.
Test material
- Reference substance name:
- Hexamethylene diisocyanate
- EC Number:
- 212-485-8
- EC Name:
- Hexamethylene diisocyanate
- Cas Number:
- 822-06-0
- Molecular formula:
- C8H12N2O2
- IUPAC Name:
- 1,6-diisocyanatohexane
- Reference substance name:
- Desmodur H
- IUPAC Name:
- Desmodur H
- Details on test material:
- - purity not specified
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright White
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Lippische Versuchstierzucht (Extertal, Germany)
- Age at study initiation: no data
- Weight at study initiation: mean weight ca. 253 g
- Housing: 4 or 5 animals per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 +/- 2
- Humidity (%): 40-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- petrolatum
- Concentration / amount:
- 1st induction: 10 % ;
2nd induction: undiluted ;
1st and 2nd challenge: 0.3 % and 1.0 % (application volume: 0.2 ml each)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 1st induction: 10 % ;
2nd induction: undiluted ;
1st and 2nd challenge: 0.3 % and 1.0 % (application volume: 0.2 ml each)
- No. of animals per dose:
- test groups: 20
control groups: 10 - Details on study design:
- RANGE FINDING TEST: In a pilot study for the challenge the skin irritation was examined with 0.03, 0.1, 0.3 and 1.0 % (24 hours, occlusive) using 4 animals; the animals were treated with FCA and paraffin oil like the control animals; only one animal showed skin irritation (grade 1) at the 1.0 % concentration one day after application.
MAIN STUDY
1st induction: Intradermal injections
Day 0 - treatment group
Three pairs of intradermal injections of 0.1 ml volume are given in the shoulder region which was shaved.
Injection 1 (cranial): a 1:1 mixture (v/v) Freunds Complete Adjuvans (FCA)/water
Injection 2 (medial): 10 % test substance in paraffin oil
Injection 3 (caudal): 10 % test substance formulated in FCA
Day 0 - control group
Three pairs of intradermal injections of 0.1 ml volume are given in the same sites as in the treated animals.
Injection 1 (cranial): a 1:1 mixture (v/v) FCA/water
Injection 2 (medial): paraffin oil
Injection 3 (caudal): paraffin oil in FCA
2nd induction: Intradermal injections
Day 7 - treatment group
Each animal received 2 injections of 0.025 ml undiluted test substance (ca. 0.05 ml per animal) in the shorn shoulder region of the first induction treatment.
Day 7 - control group
Control animals were not treated.
1st and 2nd challenge: Topical application under occlusive conditions
Days 21 and 35 - treatment and control groups
Patches with the test substance (application volume: 0.2 ml each) were applied in concentrations of 0.3 or 1.0 % to the left and right shorn flanks of the animals. The patches are held in contact by an occlusive dressing for 6 hours.
Observations - treatment and control groups:
0 = no visible change
1 = discrete or patchy erythema
2 = moderate and confluent erythema
3 = intense erythema and swelling
Approximately 24 hours after this observation a second observation (48 hours) and third (72 hours) is made and once again recorded. An animal is evaluated as sensitized if the treated animal showes a skin reaction graded >=1 without any evidence of irritation. - Challenge controls:
- yes
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other: 1st challenge on Day 21
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.3 % HDI in petrolatum
- No. with + reactions:
- 15
- Total no. in group:
- 17
- Clinical observations:
- erythema (mean score: 1.1)
- Reading:
- other: 1st challenge on Day 21
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.3 % HDI in petrolatum
- No. with + reactions:
- 16
- Total no. in group:
- 17
- Clinical observations:
- erythema (mean score: 1.0)
- Reading:
- other: 1st challenge on Day 21
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 0.3 % HDI in petrolatum
- No. with + reactions:
- 4
- Total no. in group:
- 17
- Clinical observations:
- erythema (mean score: 0.2)
- Reading:
- other: 1st challenge on Day 21
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1.0 % HDI in petrolatum
- No. with + reactions:
- 15
- Total no. in group:
- 17
- Clinical observations:
- erythema (mean score: 1.5)
- Reading:
- other: 1st challenge on Day 21
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1.0 % HDI in petrolatum
- No. with + reactions:
- 16
- Total no. in group:
- 17
- Clinical observations:
- erythema (mean score: 1.4)
- Reading:
- other: 1st challenge on Day 21
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 1.0 % HDI in petrolatum
- No. with + reactions:
- 8
- Total no. in group:
- 17
- Clinical observations:
- erythema (mean score: 0.6)
- Reading:
- other: 1st challenge on Day 21
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.3 % or 1.0 % HDI in petrolatum
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Reading:
- other: 1st challenge on Day 21
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.3 % or 1.0 % HDI in petrolatum
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Reading:
- other: 1st challenge on Day 21
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 0.3 % or 1.0 % HDI in petrolatum
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Reading:
- other: 2nd challenge on Day 35
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.3 % HDI in petrolatum
- No. with + reactions:
- 17
- Total no. in group:
- 17
- Clinical observations:
- erythema (mean score: 1.5)
- Reading:
- other: 2nd challenge on Day 35
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.3 % HDI in petrolatum
- No. with + reactions:
- 11
- Total no. in group:
- 17
- Clinical observations:
- erythema (mean score: 0.8)
- Reading:
- other: 2nd challenge on Day 35
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 0.3 % HDI in petrolatum
- No. with + reactions:
- 10
- Total no. in group:
- 17
- Clinical observations:
- erythema (mean score: 0.7)
- Reading:
- other: 2nd challenge on Day 35
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1.0 % HDI in petrolatum
- No. with + reactions:
- 17
- Total no. in group:
- 17
- Clinical observations:
- erythema (mean score: 1.9)
- Reading:
- other: 2nd challenge on Day 35
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1.0 % HDI in petrolatum
- No. with + reactions:
- 16
- Total no. in group:
- 17
- Clinical observations:
- erythema (mean score: 1.5)
- Reading:
- other: 2nd challenge on Day 35
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 1.0 % HDI in petrolatum
- No. with + reactions:
- 16
- Total no. in group:
- 17
- Clinical observations:
- erythema (mean score: 1.1)
- Reading:
- other: 2nd challenge on Day 35
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.3 % or 1.0 % HDI in petrolatum
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- erythema (mean score: 0.1)
- Reading:
- other: 2nd challenge on Day 35
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.3 % or 1.0 % HDI in petrolatum
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- erythema (mean score: 0.1)
- Reading:
- other: 2nd challenge on Day 35
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 0.3 % or 1.0 % HDI in petrolatum
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- erythema (mean score: 0.1 and 0.3)
Any other information on results incl. tables
3 out of 20 test animals died after the second induction; at the end of the study (week 6) no relevant difference in body weight development was observed between test and control groups.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Executive summary:
In a guinea pig maximization test (GPMT) similar to OECD TG 406 HDI revealed a strong skin sensitizing potential. At the topical challenges (4 and 6 weeks after the first induction treatment) 16/17 or 17/17 animals reacted with erythema according to a contact allergy after application of a 0.3 or a 1.0 % HDI formulation in petrolatum.
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