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EC number: 203-268-9 | CAS number: 105-08-8
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
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- Density
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- Endpoint summary
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- 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
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- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
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- Specific investigations
- Exposure related observations in humans
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- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Skin sensitization was examined in a Maximization study, with no evidence of sensitization.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13 May 2002 - 8 July 2002.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study was conducted before the LLNA was in force
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: D. Hall, Newchurch, Staffordshire, UK
- Age at study initiation: Four to five weeks of age
- Weight at study initiation: 348-409g
- Housing: housed in groups of five in suspended metal cages with wire mesh floors in Building 5 Room 515A (preliminary investigations) and 507B (main study investigation), Eye Research Centre, Eye, Suffolk, IP23 7PX.
- Diet (e.g. ad libitum): A vitamin C enriched guinea-pig diet (SDS FD1 MOD SQC)
- Water (e.g. ad libitum): drinking water ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 40 to 70
- Photoperiod (hrs dark / hrs light): 12/12
- Route:
- other: intradermal injection and topical application
- Vehicle:
- water
- Concentration / amount:
- Preliminary test: control, 0.05, 0.1, 0.5, 1.0, 5.0, 10, 25, 50 % w/v
main test
- induction intradermal injection : 1% w/v in water for irrigation
- induction topical application : as supplied
- topical challenge : as supplied and 50% w/v in water for injection - Route:
- other: topical application
- Vehicle:
- water
- Concentration / amount:
- Preliminary test: control, 0.05, 0.1, 0.5, 1.0, 5.0, 10, 25, 50 % w/v
main test
- induction intradermal injection : 1% w/v in water for irrigation
- induction topical application : as supplied
- topical challenge : as supplied and 50% w/v in water for injection - No. of animals per dose:
- preliminary test:
- Intradermal injection: 2 animals (control, 0.05, 0.1, 0.5, 1.0, 5.0, 10, 25, 50 % w/v per each animal)
-Topical application: 4 animals( 25, 50, 75% w/v, as supplied per each animal)
main test
test : 10 animals, control: 5 animals - Details on study design:
The intradermal and topical irritancy of a range of dilutions of CHDM was investigated to identify where possible (a) the minimum irritant test substance concentrations suitable for the induction phase of the main study and (b) a maximum nonirritant concentration by the topical route of administration and a dilution of this for the challenge phase.
The animals for the topical irritancy investigations were pre-treated with an intradermal injection of Freund's Complete Adjuvant, 50:50 with water for irrigation (Ph.Eur.), approximately one week prior to the start of the preliminary investigations.
Intradermal injections
- No. of exposures: 2
- Test groups: 2 animals (931,932)
- Control group: 2 animals (931,932)
- Site: dorsal skin on the scapular region
- Frequency of applications: once treated
- Duration: assessed approximately 24 and 72 hours later
- Concentrations: 0.05, 0.1, 0.5, 1.0, 5.0, 10, 25, 50 % w/v of 0.1ml/site
Topical application - No. of exposures: 4
- Test groups: 4 animals(933, 934, 935, 936)
- Control group: 0
- Site: dorsal skin on the scapular region
- Frequency of applications:
- Duration: assessed approximately 24 and 48 hours after removal of the dressing
- Concentrations: 25% of neat test material (0.2ml/patch)
Based on the results of the preliminary investigations, the following concentrations of CHDM were selected for the main study:
Induction intradermal injection-1% w/v in water for irrigation (This was the highest concentration that caused irritation but did not cause necrosis or give signs of toxicity).
A. INDUCTION EXPOSURE
- No. of exposures: 10
- Test groups: 10 animals (260, 261, 262, 263, 264, 265, 266, 267, 268, 269)
- Control group: 5 animals (255, 256,257,258, 259)
- Site: an approximately 4x6 cm area of dorsal skin on the scapular region
- Frequency of applications: once treated
- Duration: 22 days (6 days for intradermal injection and 16 days for topical application)
- Concentrations
for intradermal injection
1) Freund's Complete Adjuvant 50:50 with water for irrigation (Ph.Eur.).
2) CHDM, 1% w/v in water for irrigation.
3) CHDM, 1% w/v in a 50:50 mixture of Freund's Complete Adjuvant and water for irrigation.
for topical application
: approximated 0.4 ml , as supplied
B. CHALLENGE EXPOSURE
- No. of exposures: 10
- Test groups: 10 animals (260, 261, 262, 263, 264, 265, 266, 267, 268, 269)
- Control group: 5 animals (255, 256,257,258, 259)
- Site: the left flank of guinea-pig
- Frequency of applications: once treated
- Duration: evaluated approximately 24 and 48 hours after removal of the patches
- Concentrations: as supplied (0.2ml of CHDM) and 50% w/v in water for injection
RANGE FINDING TESTS:
The intradermal and topical irritancy of a range of dilutions of CHDM was investigated to identify where possible (a) the minimum irritant test substance concentrations suitable for the induction phase of the main study and (b) a maximum nonirritant concentration by the topical route of administration and a dilution of this for the challenge phase.
The animals for the topical irritancy investigations were pre-treated with an intradermal injection of Freund's Complete Adjuvant, 50:50 with water for irrigation (Ph.Eur.), approximately one week prior to the start of the preliminary investigations.
Intradermal injections: Intradermal injections (0.1ml/site) were made into the clipped and shaved flank of two guinea-pigs, using a range of concentrations (0.05% w/v to 50% w/v) of CHDM in water for irrigation. The resulting dermal responses were assessed approximately 24 and 72 hours later.
Topical application - Patches of Whatman No. 4 paper (2cm * 2cm) were saturated (volume approximately 0.2 ml per patch) with a range of concentrations (25% w/v to neat test material) of CHDM in water for irrigation and applied to the clipped and shaved flanks of each of four guinea-pigs. The patches were covered by a strip of "Blenderm" and firmly secured by "Elastoplast" wound round the trunk and fixed with an impervious plastic adhesive tape. The dressings were removed after an exposure period of approximately 24 hours and the reaction sites were assessed for erythema and oedema. Further examination of the sites was carried out approximately 24 and 48 hours after removal of the dressings.
Based on the results of the preliminary investigations, the following concentrations of CHDM were selected for the main study:
Induction intradermal injection-1% w/v in water for irrigation (This was the highest concentration that caused irritation but did not cause necrosis or give signs of toxicity).
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10 animals
- Exposure period: 24 hours
- Test groups: An approximately 4*6cm area of dorsal skin on the scapular region of the guinea-pig was clipped free of hair with electric clippers. On Day 1, three pairs of intradermal injections (0.1 ml/site) were made into an approximately 2*4 cm area within the clipped area.
The topical induction application as supplied did not produce skin irritation.
- Control group: 5 animals, During the induction phase, the control animals were treated similarly to the test animals with the exception that the test substance was omitted from the intradermal injections and topical application.
- Site: dorsal skin on the scapular region
- Frequency of applications: intradermal injection,
tropical application- six days following the injections the same scapular area was clipped and shaved free of hair and the site was pre-treated by gentle rubbing with 0.5 ml per site of 10% w/w sodium lauryl sulphate in petrolatum.
- Concentrations:
Freund's Complete Adjuvant 50:50 with water for irrigation (Ph. Eur.)
CHDM, 1 % w/v in water for irrigation.
CHDM 1 % w/v in a 50:50 mixture of Freund/s Complete Adjuvant and water for irrigation.
B. CHALLENGE EXPOSURE
- No. of exposures: 10 animals
- Day(s) of challenge: two weeks after the topical induction application (Day 22)
- Exposure period: 24 hours
- Control group and test groups: The control and test animals were challenged topically two weeks after the topical induction application (Day 22) using CHDM, as supplied and 50 % w/v in water for irrigation.
- Site: anterior site on the flank
- Concentrations: 0.2 ml of CHDM as supplied, 50% w/v in water
- Evaluation (hr after challenge): approximately 24 and 48 hours after removal of the patches.
- Positive control substance(s):
- yes
- Remarks:
- Hexyl cinnamic aldehyde
- Positive control results:
- In this study, HCA produced evidence of skin sensitization (delayed contact hypersensitivity) in eight of the ten animals, thus confirming the sensitivity of the strain of animals and reliability of the experimental technique.
- Reading:
- other: main study : intradermal injection
- Group:
- negative control
- Dose level:
- 0.1 ml per each concentration
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No erythema or oedema was seen
- Remarks on result:
- other: Reading: other: main study : intradermal injection. Group: negative control. Dose level: 0.1 ml per each concentration. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: No erythema or oedema was seen.
- Reading:
- other: main study : intradermal injection
- Group:
- test chemical
- Dose level:
- 0.1 ml per each concentration
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- erythema grade : 1 for all animals, a false indication of ioedema for all animals
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: other: main study : intradermal injection. Group: test group. Dose level: 0.1 ml per each concentration. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: erythema grade : 1 for all animals, a false indication of ioedema for all animals.
- Reading:
- other: main study : topical application
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.4 ml of CHDM
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No erythema or oedema was observed in the test animals.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: other: main study : topical application. . Hours after challenge: 48.0. Group: negative control. Dose level: 0.4 ml of CHDM. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: No erythema or oedema was observed in the test animals..
- Reading:
- other: main study: topical application
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.4 ml of CHDM
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No erythema or oedema was observed in the test animals.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: other: main study: topical application. . Hours after challenge: 48.0. Group: test group. Dose level: 0.4 ml of CHDM. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No erythema or oedema was observed in the test animals..
- Reading:
- other: challenge test
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.2 ml of CHDM
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- There was no dermal reaction.
- Remarks on result:
- other: Reading: other: challenge test. . Hours after challenge: 24.0. Group: negative control. Dose level: 0.2 ml of CHDM. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: There was no dermal reaction..
- Reading:
- other: challenge test
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.2 ml of CHDM
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- There was no dermal reaction.
- Remarks on result:
- other: Reading: other: challenge test. . Hours after challenge: 48.0. Group: negative control. Dose level: 0.2 ml of CHDM. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: There was no dermal reaction..
- Reading:
- other: challenge test
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.2 ml of CHDM
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- There was no dermal reaction.
- Remarks on result:
- other: Reading: other: challenge test. . Hours after challenge: 24.0. Group: test group. Dose level: 0.2 ml of CHDM. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: There was no dermal reaction..
- Reading:
- other: challenge test
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.2 ml of CHDM
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- There was no dermal reaction.
- Remarks on result:
- other: Reading: other: challenge test. . Hours after challenge: 48.0. Group: test group. Dose level: 0.2 ml of CHDM. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: There was no dermal reaction..
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study, CHDM did not produce evidence of skin sensitization (delayed contact hypersensitivity) in any of the ten test animals.
Therefore, CHDM is no considered to have the potential to cause skin sensitization. - Executive summary:
This study was performed to assess the skin sensitization potential of CHDM (1,4-cyclohexanedimethanol) using the guinea-pig.
The guinea-pigs were dosed by intradermal injection and topical application, as these are the routes of exposure required by the test guidelines and method.
Based on the results of a preliminary study and in compliance with the guidelines, the following dose levels were selected:
- Intradermal injection : 1% w/v in water for irrigation
- Topical application : as supplied
- Chanllenge application : as supplied and 50% w/v in water for irrigation
Ten test and five control guinea-pigs were used in the main study
In this study CHDM(1,4-cyclohexanedimethanol) did not produce evidence of skin sensitization (delayed contact hypersensitivity) in any of the ten test animals. CHDM(1,4 -cyclohexanedimethanal) is not considered to have the potential to cause skin sensitization.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
A GPMT (OECD guideline 406) GLP study was conducted in which guinea pigs were dosed by intradermal injection (1% w/v in water) and topical (as supplied) application and then followed by a challenge application two weeks later using CHDM, as supplied, and 50% w/v in water. There were no evidence of skin sensitization (delayed contact hypersensitivity) in any of the animals.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
None
Justification for classification or non-classification
No evidence of a sensitization response was observed when groups of guinea pigs were used in an OECD guideline GLP study as well as an older, non-guideline study. In the guideline study, there was no evidence of delayed hypersensitivity in any of the ten test animals and in the non-guideline study, animals immunized with 1,4-cyclohexanedimethanol using the footpad technique and challenged seven days later via dermal application had no sensitization. Based on the studies, 1,4-cyclohexanedimethanol is not classified for “Skin Sensitization” according to GHS.
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