Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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: 940-223-9 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Hostapon SLG is not skin sensitizing based on the read-across to Hostapon SG:
Hostapon SG was investigated for its skin sensitization property according to the OECD 406 (M&K). Hostapon SG is not skin sensitizing.
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:
- 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (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 performed prior to the establishment of LLNA.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH
- Age at study initiation: 5-6 weeks
- Weight at study initiation: 282 – 388 g
- Housing: Individually in Makrolon type-4 cages with standard softwood bedding
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3418 guinea pig breeding / maintenance diet, ad libidum
- Water (e.g. ad libitum): Community tap water from Füllinsdorf, ad libitum.
- Acclimation period: 2008-09-18 to 2008-10-13
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30-70 %
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 / 12 - Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- 5 % / 0.1 ml
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 50% /0.3 ml
- Day(s)/duration:
- 24h
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 5% /0.2 mL
- Day(s)/duration:
- 24h
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 5 control animals (males)
10 treated animals (males) - Details on study design:
- RANGE FINDING TESTS:
A: Intradermal injections:
Four intradermal injections (0.1 mL/site) of a 1:1 (v/v) mixture of Freund's Complete Adjuvant/physiological saline (day 1) (shaved neck of one guinea pig)
Five days later: Four intradermal injections (0.1 mL/site) at concentrations of H = 15 %, I = 10 % and J = 5 % of the test item in purified water (clipped flank of the same guinea pig)
Dermal reactions assessed 24 hrs later.
B: Epidermal applications:
Four intradermal injections (0.1 mL/site) of a 1:1 (v/v) mixture of Freund's Complete Adjuvant/physiological saline (day 1) (shaved necks of two guinea pigs)
Five days later: Epidermal application with the test item at K = 15 %, L = 10 %, M = 5 % and N = 3 % in purified water (shaved flanks of the same two guinea pigs)
Dermal reactions assessed 24 and 48 hrs after removal of the bandage.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal / epicutaneously)
- Exposure period: injected / 48 h occlusive
- Site: scapular region (clipped free of hair)
- Frequency of applications: 1 / 1
- Duration: 0 - 8 days
- Concentrations:
1st application: 5% intradermal; 2nd application: 50% epicutaneous
B.
CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 22
-Exposure period: 24 hrs
- Site: left flank (test item); right flank: vehicle (clipped free of hair)
- Concentrations: 5% occlusive epicutaneous
- Evaluation (hr after challenge): 24 and 48 hrs - Positive control substance(s):
- yes
- Remarks:
- ALPHA-HEXYLCINNAMALDEHYDE
- Positive control results:
- Discrete/patchy to moderate/confluent erythema with or without scaling was observed in nine out of ten test animals at the 24- and 48-hour reading after the challenge treatment with ALPHA-HEXYLCINNAMALDEHYDE at 1 % in PEG 300 (left shoulder). Five test animals showed discrete/patchy erythema at the 24-hour reading after treatment with ALPHAHEXYLCINNAMALDEHYDE at 0.1 % in PEG 300 (left flank). No skin effect was observed in the control group.
Based on the above mentioned findings in an adjuvant sensitization test (M&K-test) in guinea pigs and in accordance to Commission Directive 2001/59/EC, ALPHAHEXYLCINNAMALDEHYDE has to be classified and labelled as a skin sensitizer. - Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- 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.
- Key result
- 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.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Hostapon SG was investigated for its skin isensitization property according to the Guideline OECD 406 (M&K). It is not skin sensitizing.
- Executive summary:
Hostapon SG was investigated for its skin sensitization property according to the OECD 406 (M&K). As for induction, ten male guinea pigs were treated intradermally at concentration of 5% in water and one week later epidermally at concentration of 50 % in water. Five control animals were treated with vehicle only. Two weeks after the epidermal induction, all animals were epidermally challenged at concentration of 5%. None of the animals responded. Hostapon SG is not skin sensitizing.
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Justification is provided in Chapter 13.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (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 performed prior to the establishment of LLNA.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH
- Age at study initiation: 5-6 weeks
- Weight at study initiation: 282 – 388 g
- Housing: Individually in Makrolon type-4 cages with standard softwood bedding
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3418 guinea pig breeding / maintenance diet, ad libidum
- Water (e.g. ad libitum): Community tap water from Füllinsdorf, ad libitum.
- Acclimation period: 2008-09-18 to 2008-10-13
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30-70 %
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 / 12 - Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- 5 % / 0.1 ml
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 50% /0.3 ml
- Day(s)/duration:
- 24h
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 5% /0.2 mL
- Day(s)/duration:
- 24h
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 5 control animals (males)
10 treated animals (males) - Details on study design:
- RANGE FINDING TESTS:
A: Intradermal injections:
Four intradermal injections (0.1 mL/site) of a 1:1 (v/v) mixture of Freund's Complete Adjuvant/physiological saline (day 1) (shaved neck of one guinea pig)
Five days later: Four intradermal injections (0.1 mL/site) at concentrations of H = 15 %, I = 10 % and J = 5 % of the test item in purified water (clipped flank of the same guinea pig)
Dermal reactions assessed 24 hrs later.
B: Epidermal applications:
Four intradermal injections (0.1 mL/site) of a 1:1 (v/v) mixture of Freund's Complete Adjuvant/physiological saline (day 1) (shaved necks of two guinea pigs)
Five days later: Epidermal application with the test item at K = 15 %, L = 10 %, M = 5 % and N = 3 % in purified water (shaved flanks of the same two guinea pigs)
Dermal reactions assessed 24 and 48 hrs after removal of the bandage.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal / epicutaneously)
- Exposure period: injected / 48 h occlusive
- Site: scapular region (clipped free of hair)
- Frequency of applications: 1 / 1
- Duration: 0 - 8 days
- Concentrations:
1st application: 5% intradermal; 2nd application: 50% epicutaneous
B.
CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 22
-Exposure period: 24 hrs
- Site: left flank (test item); right flank: vehicle (clipped free of hair)
- Concentrations: 5% occlusive epicutaneous
- Evaluation (hr after challenge): 24 and 48 hrs - Positive control substance(s):
- yes
- Remarks:
- ALPHA-HEXYLCINNAMALDEHYDE
- Positive control results:
- Discrete/patchy to moderate/confluent erythema with or without scaling was observed in nine out of ten test animals at the 24- and 48-hour reading after the challenge treatment with ALPHA-HEXYLCINNAMALDEHYDE at 1 % in PEG 300 (left shoulder). Five test animals showed discrete/patchy erythema at the 24-hour reading after treatment with ALPHAHEXYLCINNAMALDEHYDE at 0.1 % in PEG 300 (left flank). No skin effect was observed in the control group.
Based on the above mentioned findings in an adjuvant sensitization test (M&K-test) in guinea pigs and in accordance to Commission Directive 2001/59/EC, ALPHAHEXYLCINNAMALDEHYDE has to be classified and labelled as a skin sensitizer. - Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- 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.
- Key result
- 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.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Not skin sensitizing
- Executive summary:
Hostapon SLG is assessed for its skin sensization property via read-across to Hostapon SG.
Hostapon SG was investigated for its skin sensitization property according to the OECD 406 (M&K). As for induction, ten male guinea pigs were treated intradermally at concentration of 5% in water and one week later epidermally at concentration of 50 % in water. Five control animals were treated with vehicle only. Two weeks after the epidermal induction, all animals were epidermally challenged at concentration of 5%. None of the animals responded. Hostapon SG is not skin sensitizing
Likewise, Hostapon SLG is not skin sensitizing.
Referenceopen allclose all
Skin reactions in the intradermal pretest |
||
Animal No. |
Concentration (%) |
Reactions |
671, male |
75 |
Moderate and confluent erythema Oedema and necrosis |
50 |
Moderate and confluent erythema Oedema and necrosis |
|
25 |
Moderate and confluent erythema Oedema and necrosis |
|
689, male |
15 |
Moderate and confluent erythema Necrosis |
10 |
Moderate and confluent erythema Necrosis |
|
5 |
Discrete/patch erythema |
|
Skin reactions in the intradermal pretest |
|||
Animal No. |
Concentration (%) |
Reactions after removal of badange |
|
24h |
28h |
||
672, male |
100 |
Intense erythema and swelling; Fissures |
Moderate and confluent erythema; Scaling |
75 |
Intense erythema and swelling; Fissure |
Moderate and confluent erythema; Scaling |
|
50 |
Moderate and confluent erythema |
Moderate and confluent erythema; Scaling |
|
25 |
Discrete/patchy erythema
|
No visible change
|
|
673, male |
100 |
Intense erythema and swelling; Fissures |
Moderate and confluent erythema; Scaling |
75 |
Intense erythema and swelling; Fissures |
Moderate and confluent erythema; Scaling |
|
50 |
Discrete/patchy erythema
|
No visible change
|
|
25 |
Discrete/patchy erythema
|
Discrete/patchy erythema
|
|
690, male |
15 |
Discrete/patchy erythema
|
No visible change
|
10 |
No visible change
|
No visible change
|
|
5 |
No visible change
|
No visible change
|
|
3 |
No visible change
|
No visible change
|
|
691, male |
15 |
Discrete/patchy erythema
|
No visible change
|
10 |
Discrete/patchy erythema
|
No visible change
|
|
5 |
No visible change
|
No visible change
|
|
3 |
No visible change
|
No visible change
|
|
Skin reactions after epidermal induction of with test item treated animals |
||
Animal No. |
Reactions after removal of badange |
|
24h |
48h |
|
679 |
Discrete/patchy erythema |
Discrete/patchy erythema |
680 |
Discrete/patchy erythema |
Discrete/patchy erythema |
681 |
Discrete/patchy erythema |
No visible change |
682 |
Discrete/patchy erythema |
Discrete/patchy erythema |
683 |
Discrete/patchy erythema |
Discrete/patchy erythema |
684 |
Discrete/patchy erythema |
Discrete/patchy erythema |
685 |
Discrete/patchy erythema |
No visible change |
686 |
Discrete/patchy erythema |
Discrete/patchy erythema |
687 |
Moderate and confluent erythema |
Discrete/patchy erythema |
688 |
Discrete/patchy erythema |
Discrete/patchy erythema |
Skin reactions after epidermal challenge of with test item treated animals |
||
Animal No. |
Reactions after removal of badange |
|
24h |
48h |
|
679 |
No visible change |
No visible change |
680 |
No visible change |
No visible change |
681 |
No visible change |
No visible change |
682 |
No visible change |
No visible change |
683 |
No visible change |
No visible change |
684 |
No visible change |
No visible change |
685 |
No visible change |
No visible change |
686 |
No visible change |
No visible change |
687 |
No visible change |
No visible change |
688 |
No visible change |
No visible change |
Skin reactions in the intradermal pretest |
||
Animal No. |
Concentration (%) |
Reactions |
671, male |
75 |
Moderate and confluent erythema Oedema and necrosis |
50 |
Moderate and confluent erythema Oedema and necrosis |
|
25 |
Moderate and confluent erythema Oedema and necrosis |
|
689, male |
15 |
Moderate and confluent erythema Necrosis |
10 |
Moderate and confluent erythema Necrosis |
|
5 |
Discrete/patch erythema |
|
Skin reactions in the intradermal pretest |
|||
Animal No. |
Concentration (%) |
Reactions after removal of badange |
|
24h |
28h |
||
672, male |
100 |
Intense erythema and swelling; Fissures |
Moderate and confluent erythema; Scaling |
75 |
Intense erythema and swelling; Fissure |
Moderate and confluent erythema; Scaling |
|
50 |
Moderate and confluent erythema |
Moderate and confluent erythema; Scaling |
|
25 |
Discrete/patchy erythema
|
No visible change
|
|
673, male |
100 |
Intense erythema and swelling; Fissures |
Moderate and confluent erythema; Scaling |
75 |
Intense erythema and swelling; Fissures |
Moderate and confluent erythema; Scaling |
|
50 |
Discrete/patchy erythema
|
No visible change
|
|
25 |
Discrete/patchy erythema
|
Discrete/patchy erythema
|
|
690, male |
15 |
Discrete/patchy erythema
|
No visible change
|
10 |
No visible change
|
No visible change
|
|
5 |
No visible change
|
No visible change
|
|
3 |
No visible change
|
No visible change
|
|
691, male |
15 |
Discrete/patchy erythema
|
No visible change
|
10 |
Discrete/patchy erythema
|
No visible change
|
|
5 |
No visible change
|
No visible change
|
|
3 |
No visible change
|
No visible change
|
|
Skin reactions after epidermal induction of with test item treated animals |
||
Animal No. |
Reactions after removal of badange |
|
24h |
48h |
|
679 |
Discrete/patchy erythema |
Discrete/patchy erythema |
680 |
Discrete/patchy erythema |
Discrete/patchy erythema |
681 |
Discrete/patchy erythema |
No visible change |
682 |
Discrete/patchy erythema |
Discrete/patchy erythema |
683 |
Discrete/patchy erythema |
Discrete/patchy erythema |
684 |
Discrete/patchy erythema |
Discrete/patchy erythema |
685 |
Discrete/patchy erythema |
No visible change |
686 |
Discrete/patchy erythema |
Discrete/patchy erythema |
687 |
Moderate and confluent erythema |
Discrete/patchy erythema |
688 |
Discrete/patchy erythema |
Discrete/patchy erythema |
Skin reactions after epidermal challenge of with test item treated animals |
||
Animal No. |
Reactions after removal of badange |
|
24h |
48h |
|
679 |
No visible change |
No visible change |
680 |
No visible change |
No visible change |
681 |
No visible change |
No visible change |
682 |
No visible change |
No visible change |
683 |
No visible change |
No visible change |
684 |
No visible change |
No visible change |
685 |
No visible change |
No visible change |
686 |
No visible change |
No visible change |
687 |
No visible change |
No visible change |
688 |
No visible change |
No visible change |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Justification for classification or non-classification
Hostapon SLG is assessed based on the read-across to Hostapon SG.
Hostapon SG was investigated for its skin sensitization property according to the OECD 406 (M&K). Hostapon SG is not skin sensitizing.
No classification is assigned to Hostapon SLG.
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.
