Registration Dossier
Registration Dossier
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EC number: 309-831-6 | CAS number: 101227-08-1
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- Due to the structural similarities and consistent trend in toxicokinetic and (eco)toxicological behaviour, the selected source substances are considered suitable and systemic human health effects and ecotoxicological effects can be directly read-across in accordance with Regulation (EC) No 1907/2006, Annex XI, 1.5.
- Reason / purpose for cross-reference:
- read-across source
- Positive control substance(s):
- no
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 20%
- No. with + reactions:
- 1
- Total no. in group:
- 19
- Clinical observations:
- One animal died after first induction
- 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: 19.0. Clinical observations: One animal died after first induction.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 20%
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Clinical observations:
- No
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 20%. No with. + reactions: 5.0. Total no. in groups: 10.0. Clinical observations: No.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Clinical observations:
- One animal died after first induction
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 20%. No with. + reactions: 0.0. Total no. in groups: 19.0. Clinical observations: One animal died after first induction.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 20%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- No
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 20%. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: No.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- CLP: not classified
DSD: not classified - Executive summary:
A Guinea pig maximization test was performed according to OECD Guideline 406. The similar substance 2-ethyl-hexylester with fatty acids C8-C14 was not sensitising.
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- Due to the structural similarities and consistent trend in toxicokinetic and (eco)toxicological behaviour, the selected source substances are considered suitable and systemic human health effects and ecotoxicological effects can be directly read-across in accordance with Regulation (EC) No 1907/2006, Annex XI, 1.5.
- Reason / purpose for cross-reference:
- read-across source
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25% (intradermal induction, 50% (challenge)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25% (intradermal induction, 50% (challenge) . No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25% (intradermal induction, 50% (challenge)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25% (intradermal induction, 50% (challenge) . No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25% (intradermal induction, 50% (challenge)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25% (intradermal induction, 50% (challenge) . No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25% (intradermal induction, 50% (challenge)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25% (intradermal induction, 50% (challenge) . No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- CLP: not classified
DSD: not classified - Executive summary:
A Guinea pig maximization test was performed according to OECD Guideline 406. 20 test and 10 control animals (Dunkin-Hartley guinea pigs) were induced with 25% substance solution and challenged with a 50% test substance solutionl. 24 and 48 hours after termination of challenge exposure skin readings revealed no indications for a skin sensitising potential of the similar substance Fatty acids, C16-18, 2-ethylhexyl esters.
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 2006-08-30 until 2006-10-12
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study performed according to internationally accepted testing guideline, well documented, read-across, metabolite
- Justification for type of information:
- Due to the structural similarities and consistent trend in toxicokinetic and (eco)toxicological behaviour, the selected source substances are considered suitable and systemic human health effects and ecotoxicological effects can be directly read-across in accordance with Regulation (EC) No 1907/2006, Annex XI, 1.5.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The test was performed before the LLNA-test was required.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Kisslegg, Germany
- Age at study initiation: 5 - 7 weeks
- Weight at study initiation: 358 - 367 g (pretest group); 345 - 416 g (control and test group)
- Housing: individually in Makrolon cages type IV with standard softwood bedding
- Diet (e.g. ad libitum): Provimi Kliba 3418 libitum, supplied by Provimi Klima, Kaiseraugst, Switzerland
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 17 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12 - Route:
- intradermal and epicutaneous
- Vehicle:
- other: sesame oil
- Concentration / amount:
- - Concentrations used for induction: intradermal treatment: 50%; dermal treatment: 100%
- Concentration in Freunds Complete Adjuvant (FCA): 50% test substance in a mixture of FCA and physiological saline (1:1)
- Concentrations used for challenge: 50% - Route:
- epicutaneous, occlusive
- Vehicle:
- other: sesame oil
- Concentration / amount:
- - Concentrations used for induction: intradermal treatment: 50%; dermal treatment: 100%
- Concentration in Freunds Complete Adjuvant (FCA): 50% test substance in a mixture of FCA and physiological saline (1:1)
- Concentrations used for challenge: 50% - No. of animals per dose:
- test group: 20 animals
control group: 10 animals - Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1
- Exposure period: intradermal: 50% v/v in physiological saline
- Concentration in Freunds Complete Adjuvants (FCA): 50% test substance in a mixture of FCA and physiological saline (1:1)
- Test group: dermal: 0.3 ml test substance (2 x 4 cm patch)
- Control group: 0.3 ml sesame oil (2 x 4 cm patch)
- Frequency of applications: day 1: intradermal treatment, day 8: pretreatment and day 22 challenge treatment
- Duration: removal of patches after 48 hours
- Concentrations: 100% test substance
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: on day 22
- Exposure period: dermal application for 24 hours
- Test groups: test substance (3 x 3 cm patch)
- Control group: test substance (3 x 3 cm patch)
- Site: left flanks
- Concentrations: 50% v/v
- Evaluation (hr after challenge): 24 and 48 hours after application - Challenge controls:
- see above B. Challenge exposure
- Positive control substance(s):
- yes
- Remarks:
- Alpha-hexylcinnamaldehyde (regular historical positive control in the laboratory)
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of this study the metabolite 2-butyloctan-1-ol is not sensitising.
- Executive summary:
Based on the results of this study the metabolite 2-butyloctan-1-ol is not sensitising.
Referenceopen allclose all
Main study:
Intracutaneous induction: After one hour, weak effects were observed in 7 of 20 treated animals and none of the control animals. 24 h after treatment, 11 of 20 treated animals showed weak effekts and again none of the control animals.
Epicutaneous induction: After one hour, weak up to moderate skin reactions were observed in 16 of 19 treated animals (one died after exposure) and in 7 of 10 control animals. 24 h later mostly weak effects were observed in 10 treated animals and in 2 of the control animals.
Challenge readings - grades of skin reaction of individual animals
Animal No. |
Intracut. induction |
Epicut. induction |
Challenge |
|||
1 h |
24 h |
1 h |
24 h |
24 h |
48 h |
|
Control Animals |
||||||
27 |
0 |
0 |
1 |
0 |
1 |
0 |
28 |
0 |
0 |
1 |
0 |
1 |
0 |
29 |
0 |
0 |
1 |
0 |
0 |
0 |
30 |
0 |
0 |
1 |
0 |
0 |
0 |
31 |
0 |
0 |
0 |
0 |
1 |
0 |
32 |
0 |
0 |
2 |
1 |
0 |
0 |
33 |
0 |
0 |
1 |
1 |
1 |
0 |
34 |
0 |
0 |
0 |
0 |
1 |
1 |
35 |
0 |
0 |
0 |
0 |
0 |
0 |
36 |
0 |
0 |
1 |
0 |
0 |
0 |
Test Animals |
||||||
1 |
0 |
0 |
2 |
1 |
0 |
0 |
2 |
1 |
0 |
2 |
0 |
0 |
0 |
3 |
0 |
1 |
1 |
0 |
0 |
0 |
4 |
1 |
1 |
1 |
1 |
0 |
0 |
5 |
1 |
1 |
1 |
0 |
0 |
0 |
6 |
0 |
1 |
1 |
0 |
0 |
0 |
7 |
1 |
1 |
0 |
0 |
0 |
0 |
8 |
0 |
0 |
1 |
1 |
0 |
0 |
9 |
1 |
1 |
- |
- |
- |
- |
10 |
0 |
0 |
1 |
0 |
0 |
0 |
11 |
0 |
0 |
0 |
0 |
0 |
0 |
12 |
0 |
1 |
2 |
1 |
0 |
0 |
13 |
0 |
0 |
0 |
0 |
0 |
0 |
14 |
0 |
0 |
0 |
0 |
0 |
0 |
15 |
1 |
0 |
0 |
0 |
0 |
0 |
16 |
0 |
1 |
2 |
2 |
1 |
0 |
17 |
0 |
0 |
1 |
1 |
0 |
0 |
18 |
0 |
1 |
2 |
2 |
0 |
0 |
19 |
0 |
1 |
0 |
0 |
0 |
0 |
20 |
1 |
0 |
1 |
1 |
0 |
0 |
One animal died after first exposure. No significant differences in the gain of body weight was observed between treatment and control group.
Table 1: Challenge readings
Group |
Sex |
Animals |
24 h scoring period |
48 h scoring period |
|||||||
Erythema |
Edema |
Erythema |
Edema |
||||||||
LF |
RF |
LF |
RF |
LF |
RF |
LF |
RF |
||||
Control |
Males |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
4 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
Females |
16 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
17 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
18 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
19 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
20 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
Treated |
Males |
6 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
8 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
9 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
10 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
11 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
12 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
13 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
14 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
15 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
Females |
21 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
22 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
23 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
24 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
25 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
26 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
27 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
28 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
29 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
30 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
No deaths occured. No significant differences in the gain of body weight was observed between treatment and control group.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
A Guinea pig maximization test was performed according to OECD Guideline 406 on the source substance Fatty acids, C16-18, 2-ethylhexyl esters.
20 test and 10 control animals (Dunkin-Hartley guinea pigs) were induced with 25% substance solution and challenged with a 50% test substance solution. 24 and 48 hours after termination of challenge exposure skin readings revealed no indications of a skin sensitising potential of the source substance Fatty acids, C16-18, 2-ethylhexyl esters. In a second test performed according to OECD Guideline 406 the source substance 2-ethyl-hexylester with fatty acids C8-C14 was not sensitising to guinea pigs.
Also the possible metabolite 2 -butyloctan-1 -ol was not sensitising in an OECD 406 -test.
Therefore it is likely that also the test substance has no skin sensitising properties.
Migrated from Short description of key information:
All the available studies on source substances showed no skin sensitising effects. The target substance is not expected to be skin sensitising.
Justification for selection of skin sensitisation endpoint:
All the available studies on source substances showed no skin sensitising effects. The target substance is not expected to be skin sensitising.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The source substances had no skin sensitising properties. Therefore a classification according to Directive 67/548/EEC and Regulation (EC) No 1272/2008 is not required.
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.
