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Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
See section 13.2 for the read-across justification.
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 OECD Guideline for Local Lymph node assay 9LLNA) OECD TG 429 acknowledges that there are some limitations to this test method for certain chemistries, it states:

“Despite the advantages of the LLNA over TG 406, it should be recognised that there are certain limitations that may necessitate the use of TG 406 (13) (e.g. false negative findings in the LLNA with certain metals, false positive findings with certain skin irritants [such as some surfactant type chemicals] (19) (20), or solubility of the test substance)”.

Ethanol, 2,2'-iminobis-, N-C12-18-alkyl derives and the read across source (Z)-2,2’-(Octadec-9-enylimino)bisethanol CAS No 14127-82-7 are closely structurally related, corrosive/ extreme skin irritant substances which are surfactants. Based on this the LLNA not an appropriate test for skin sensitisation and the data from the available Guinea Pig Maximisation test (OECD TG 406) is the appropriate animal test data.

Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories France, L'Arbresle, France.
- Age at study initiation: 1-2 months
- Weight at study initiation: males 361 +/- 18 g, females 339 +/- 25g
- Housing: Polycarbonate cages with stainless steel tops. Autoclaved sawdust bedding (SICA, Alfortville, France)
- Diet (e.g. ad libitum): ad libitum, 106 pelleted diet (SAFE, Villemoisson, Epiny-sur-Orge, France
- Water (e.g. ad libitum): ad libitum via polypropylene bottle. Water filtered by a FG Millipor membrane (0.22 micron)
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 30 - 70
- Air changes (per hr): approximately 12 cycles of filtered, no-recycled air
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 19th April 2005 To: 27th May 2005
Route:
intradermal and epicutaneous
Vehicle:
other: corn oil for intradermal induction. topical induction ethanol/water (80/20). Acetone for the challenge phase.
Concentration / amount:
Intradermal induction injections:
Freunds complete adjuvant (FCA) diluted to 50% (v/v) with 0.9% NaCl (both groups)
Test substance at a concentration of 0.1% in corn oil (treated group) of corn oil vehicle alone (control group)
Test substance at the concentration of 0.1% in a mixture of FCA/0.9% NaCl (50/50 w/w) (treated group) or corn oil vehicle at a concentration of
50% (w/v) in a mixture of FCA/0.9% NaCl (50/50, v/v)
Topical induction: 10% of the test substance in ethanol/water (80/20).
Challenge dosing:
1% (w/w) test substance in acetone
Route:
epicutaneous, occlusive
Vehicle:
other: corn oil for intradermal induction. topical induction ethanol/water (80/20). Acetone for the challenge phase.
Concentration / amount:
Intradermal induction injections:
Freunds complete adjuvant (FCA) diluted to 50% (v/v) with 0.9% NaCl (both groups)
Test substance at a concentration of 0.1% in corn oil (treated group) of corn oil vehicle alone (control group)
Test substance at the concentration of 0.1% in a mixture of FCA/0.9% NaCl (50/50 w/w) (treated group) or corn oil vehicle at a concentration of
50% (w/v) in a mixture of FCA/0.9% NaCl (50/50, v/v)
Topical induction: 10% of the test substance in ethanol/water (80/20).
Challenge dosing:
1% (w/w) test substance in acetone
No. of animals per dose:
10 males and 10 females for the vehicle control group
20 males and 20 females for the test substance group
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: Intradermal injection single exposure at six injection points. Cutaneous single application on day 8.
- Exposure period: For cutaneous application exposure was for 48 hours.
- Test groups: Backs of guinea pigs were clipped for an area of 4cm x 2cm in their interscapular area. 6 intradermal injections on day 1, 2 of FCA at 50 %( v/v) in 0.9% NaCl in the anterior part of the clipped area. 2 injections of the test substance at 0.1% (w/w) in corn oil in the middle of the area. 2 injections of the test substance at 0.1% (w/w) in a mixture of FCA/0.9% NaCl (50/50).
No topical application of sodium lauryl sulfate was necessary on day 7 due to test substance being irritant. On day 8 all test animals were exposed to 10% (w/w) test substance fully loaded on a 8cm2 filter paper applied under an occlusive dressing on the intrescapular area for 48 hours.
- Control group:
- Site: The clipped intrescapular are of the back
- Frequency of applications: Intradermal injections on day 1 followed by cutaneous application on day 8.
- Duration: Cutaneous application 48 hours
- Concentrations: For the intradermal injection 6 intradermal injections on day 1, 2 of FCA at 50 %( v/v) in 0.9% NaCl in the anterior part of the clipped area. 2 injections of the corn oil vehicle in the middle of the area. 2 injections of a mixture of FCA/0.9% NaCl (50/50).
On day 8 all animals were exposed to an 8cm2 filter paper fully loaded with the ethanol/water (80/20) vehicle applied under an occlusive dressing on the intrescapular area for 48 hours.

B. CHALLENGE EXPOSURE
- No. of exposures: On day 22 the treated and the test animals received a single application of the test substance and the vehicle control.
- Day(s) of challenge: Day 22
- Exposure period: 24 hours - Chamber held in contact with the skin by an adhesive anallergenic waterproof plaster.
- Test groups: The filter paper of a chamber (Finn Chamber) was full loaded with the test substance at a concentration of 1%(w/w) in acetone, applied to the shaved area of the posterior left flank. The acetone vehicle was applied under the same condition to the skin of the posterior left flank.
- Control group: They received the same challenge exposure with test substance and vehicle control as the test group.
- Site: The shaved left and right posterior flanks
- Concentrations: 1% test substance (w/w) in acetone or acetone vehicle control
- Evaluation (hr after challenge): 24 and 48 hours after removal of the dressing with the challenge application.

OTHER:
Positive control substance(s):
yes
Remarks:
Mercaptobenzthiazole
Positive control results:
1% (w/w) Mercaptobenzothiazole was used for the intradermal induction and 20% (W/W) for the cutaneous induction on day 8. followed by 22% (w/w) on the day 22 challenge. The vehicle was corn oil. There were 5 control animals and 10 treated animals.
Under the experimental conditions based on the Magnusson and Kligman method, the mercaptobenzthiazole positive control induced a positive skin sensitisation in 80% (8/10) guinea pigs.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
corn oil intradermal and ethanol/water cutaneous
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No clinical signs
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: corn oil intradermal and ethanol/water cutaneous. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No clinical signs.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
Corn oil intradermal, ethanol/water cutaneous
No. with + reactions:
2
Total no. in group:
10
Clinical observations:
Discrete erythema (grade 1)
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: Corn oil intradermal, ethanol/water cutaneous. No with. + reactions: 2.0. Total no. in groups: 10.0. Clinical observations: Discrete erythema (grade 1).
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.1% intradermal and 10% for cutaneous induction
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No clinical signs
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1% intradermal and 10% for cutaneous induction. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No clinical signs.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.1% for intradermal and 10% for cutaneous induction
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No clinical signs
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.1% for intradermal and 10% for cutaneous induction. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No clinical signs.
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
1% for inradermal and 20% for cutaneous induction and challenge
No. with + reactions:
8
Total no. in group:
10
Clinical observations:
Oedema and dryness of skin
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
1% for inradermal and 20% fr cutaneous induction and challenge
No. with + reactions:
8
Total no. in group:
10
Clinical observations:
Oedema and dryness of skin
Preliminary Study
Administration by intradermal route
 Animal   Concentration of the   Scoring after treatment     
 number   test item % (w/w)   24 hours   48 hours   6 days 
 male 301   25 + FCA   N   N   - 
     25   N   N   - 
     10 + FCA   N   N   - 
     10   I   N   - 
     5 + FCA   I   N   - 
     5   I   N   - 
 female 302   25 + FCA   N   N   - 
     25   N   N   - 
     10 + FCA   N   N   - 
     10   N   N   - 
     5 + FCA   I   N   - 
     5   I   N   - 
 male 305   2.5 + FCA   I   N   - 
     2.5   I   N   - 
     1 + FCA   I   N   - 
     1   I   I   - 
     0.5 + FCA   I   I   - 
     0.5   LI   LI   - 
 female 306   2.5 + FCA   I   N   - 
     2.5   I   N   - 
     1 + FCA   I   N   - 
     1   I   I   - 
     0.5 + FCA   I   I   - 
     0.5   I   I   - 
 male 309   0.5 + FCA   I   I   A 
     0.5   LI   LI   I 
     0.25 + FCA   I   I   I 
     0.25   LI   LI   LI 
     0.1 + FCA   I   I   I 
     0.1   LI   LI   LI 
 female 310   0.5 + FCA   I   I   A 
     0.5   LI   LI   I 
     0.25 + FCA   I   I   A 
     0.25   LI   LI   LI 
     0.1 + FCA   I   I   I 
     0.1   LI   LI   LI 
FCA : mixture Freund's Complete Adjuvant/0.9% NaCl (50/50, v/v)
N : necrosis
I : irritation
LI : slight irritation
A : crusts
- : sacrificed animals
In order to respect the criteria for the selection of concentrations (the concentration
 should be well-tolerated systemically and locally, intradermal injections should 
cause moderate irritant effect but no necrosis or ulceration of the skin),
 the concentration chosen for the main study was 0.1% (w/w).

Application by cutaneous route
Results were as follows:
Under the conditions of the induction phase
 Animal   Concentration of the   Scoring after removal of the dressing       
 number   test item % (w/w)   24 hours   48 hours     
 male 307   25   2   2     
 female 308   10   1   1     
Under the conditions of the challenge phase
 Animal   Concentration of the       Scoring after removal of the dressing       
 number   test item %       24 hours   48 hours     
 male 301   100   RF   LA   -     
     50 (w/w)   LF   3/A   -     
 female 302   100   RF   LA   -     
     50 (w/w)   LF   LA   -     
 male 305   25 (w/w)   RF   LN   -     
     10 (w/w)   LF   2/Oe   -     
 female 306   25 (w/w)   RF   LN   -     
     10 (w/w)   LF   2/Oe   -     
 male 309   5 (w/w)   RF   2/Oe   2/A     
     2.5 (w/w)   LF   0   0     
 female 310   5 (w/w)   RF   2/A   3/A     
     2.5 (w/w)   LF   1   1     
 male 311   1 (w/w)   RF   0   0     
     0.5 (w/w)   LF   0   0     
 female 312   1 (w/w)   RF   0   0     
     0.5 (w/w)   LF   0   0     
             
RF : right flank
LF : left flank
LA : scoring masked by crusts
A : crusts
LN : scoring masked by necrosis
Oe : oedema
- : sacrificed animals
On removal of the dressing, no residual test item was observed.
In order to respect the criteria for the selection of concentrations (the concentrations should be 
well-tolerated systemically and locally, cutaneous application for the induction should cause at most 
weak or moderate skin reactions or be the maximal practicable concentration, cutaneous application 
for the challenge phase should be the highest concentration which does not cause irritant effect), the
 concentration chosen for the topical application of the induction phase (day 8) was 10% (w/w). 
For the challenge application (day 22), it was 1% (w/w).

Application by cutaneous route
Results were as follows:
Under the conditions of the induction phase
 Animal   Concentration of the   Scoring after removal of the dressing       
 number   test item % (w/w)   24 hours   48 hours     
 male 307   25   2   2     
 female 308   10   1   1     
Under the conditions of the challenge phase
 Animal   Concentration of the       Scoring after removal of the dressing       
 number   test item %       24 hours   48 hours     
 male 301   100   RF   LA   -     
     50 (w/w)   LF   3/A   -     
 female 302   100   RF   LA   -     
     50 (w/w)   LF   LA   -     
 male 305   25 (w/w)   RF   LN   -     
     10 (w/w)   LF   2/Oe   -     
 female 306   25 (w/w)   RF   LN   -     
     10 (w/w)   LF   2/Oe   -     
 male 309   5 (w/w)   RF   2/Oe   2/A     
     2.5 (w/w)   LF   0   0     
 female 310   5 (w/w)   RF   2/A   3/A     
     2.5 (w/w)   LF   1   1     
 male 311   1 (w/w)   RF   0   0     
     0.5 (w/w)   LF   0   0     
 female 312   1 (w/w)   RF   0   0     
     0.5 (w/w)   LF   0   0     
             
RF : right flank
LF : left flank
LA : scoring masked by crusts
A : crusts
LN : scoring masked by necrosis
Oe : oedema
- : sacrificed animals
On removal of the dressing, no residual test item was observed.
In order to respect the criteria for the selection of concentrations (the concentrations should be 
well-tolerated systemically and locally, cutaneous application for the induction should cause at most 
weak or moderate skin reactions or be the maximal practicable concentration, cutaneous application 
for the challenge phase should be the highest concentration which does not cause irritant effect), the
 concentration chosen for the topical application of the induction phase (day 8) was 10% (w/w). 
For the challenge application (day 22), it was 1% (w/w).

MAIN STUDY

 

The test substance was not soluble in 0.9% NaCl: two phases were observed.

The vehicle chosen for intradermal injections was corn oil: a solution was obtained at the concentration of 25%; the dosage form preparation at the concentration of 25% (w/w) passed freely through a needle and into the dermis.

For topical applications, the vehicles used were a mixture ethanol/water (80/20) for the induction phase and acetone for the challenge application: solutions obtained whatever the proportion.

 

Clinical examinations

Marked local reactions at the intradermal injection sites were noted in a few animals of the treated group, between days 21 to 25.

No systemic clinical signs and no mortality were observed during the study.

 

Body weight

The body weight change of treated animals was similar to that of controls.

Challenge phase - Scoring of cutaneous reactions
Scoring of skin reactions was as follows
         Control group       
 Sex   Animal   24 hours   48 hours     
     number   LF   RF   LF   RF 
 Male   81   0   0   0   0 
     82   0   0   0   0 
     83   0   0   0   1 
     84   0   0   0   0 
     85   0   0   0   0 
 Female   96   0   0   0   1 
     97   0   0   0   0 
     98   0   0   0   0 
     99   0   0   0   0 
     100   0   0   0   0 
           
LF : left flank (vehicle)
RF : right flank (test item at the concentration of 1% (w/w))
    Treated Group      
 Sex   Animal   24 hours   48 hours     
     number   LF   RF   LF   RF 
 Male   86   0   0   0   0 
     87   0   0   0   0 
     88   0   0   0   0 
     89   0   0   0   0 
     90   0   0   0   0 
     91   0   0   0   0 
     92   0   0   0   0 
     93   0   0   0   0 
     94   0   0   0   0 
     95   0    0    0    0  
 Female   101   0   0   0   0 
     102   0   0   0   0 
     103   0   0   0   0 
     104   0   0   0   0 
     105   0   0   0   0 
     106   0   0   0   0 
     107   0   0   0   0 
     108   0   0   0   0 
     109   0   0   0   0 
     110   0   0   0   0 
           
LF : left flank (vehicle)
RF : right flank (test item at the concentration of 1% (w/w))
On removal of the dressing, no residual test item was observed.
After the challenge application, a discrete erythema (grade 1) was observed in 2/10 animals 
of the control group at the 48-hour reading.
No cutaneous reactions were observed in the treated group.
Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Under our experimental conditions and according to the maximization method of Magnusson and Kligman, the test substnace CECAJEL 210 (batch No. 9194) does not induce delayed contact hypersensitivity in guinea pigs.
Executive summary:

The potential of the test item (Z) -2,2’-(Octadec-9-enylimino) bisethanol CAS 13127-82-7 to induce delayed contact hypersensitivity was evaluated in guinea pigs according to the maximization method of Magnusson and Kligman and to OECD (No. 406, 17th July 1992) and EC (96/54/EEC, B.6, 30th July 1996) guidelines. The study was conducted in compliance with the principles of Good Laboratory Practice Regulations.

 

Methods

 

Thirty guinea pigs were allocated to two groups: a control group of five males and five females and a treated group of ten males and ten females. On day 1, three pairs of intradermal injections were performed in the interscapular region of all animals:

• Freund's complete adjuvant (FCA) diluted to 50% (v/v) with 0.9% NaCl (both groups),

• test item at the concentration of 0.1% in corn oil (treated group) or vehicle alone (control group),

• test item at the concentration of 0.1% in a mixture FCA/0.9% NaCl (50/50, w/w) (treated group) or vehicle at the concentration of 50% (w/v) in a mixture FCA/0.9% NaCl (50/50, v/v) (control group).

On day 8, the animals of the treated group received a topical application of the test item at the concentration of 10% (w/w) in ethanol/water (80/20) to the same test site, which was then covered by an occlusive dressing for 48 hours. The animals of the control group received an application of the vehicle under the same experimental conditions.

On day 22, all animals of both groups were challenged by a cutaneous application of the test item at the concentration of 1% (w/w) in acetone to the right flank. The test item was maintained under an occlusive dressing for 24 hours. The vehicle was applied to the left flank under the same experimental conditions. Skin reactions were evaluated approximately 24 and 48 hours after removal of the dressing.

At the end of the study, the animals were killed without examination of internal organs. No skin samples were taken from the challenge application sites. No histological examination was performed.

 

Results

No systemic clinical signs and no deaths were noted during the study. No relevant cutaneous reactions were observed after the challenge application.

 

Conclusion

Under the experimental conditions and according to the maximization method of Magnusson and Kligman, the test substance (Z) -2,2’-(Octadec-9-enylimino) bisethanol CAS 13127-82-7d oes not induce delayed contact hypersensitivity in guinea pigs.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

There is a skin sensitisation study for a similar primary fatty amine ethoxylate, based on a different fatty acid. This related substance (Z)-2,2’-(Octadec-9-enylimino)bisethanol CAS 13127-82-7, is based on a fatty acid which is predominatly (>80%) C18 and C18 unsaturated. 2, 2’-(C12-18 evennumbered alkyl imino) diethanol CAS No 71786-60-2 is based on the same amine but consists of a range of fatty acid chain lengths C12, C14, C16 and C18, there is typically >50% C12 but also >10% of the other carbon chain lengths. Chemicals that induce skin sensitisation have to firstly react with proteins in the skin to from a hapten and which can then be detected as foreign by the immune system. It has been postulated that some fatty acids may have skin sensitising potential related to their degree of unsaturation leading to increased reactivity. If unsaturation does provide potential for skin sensitisation the (Z)-2,2’-(Octadec-9-enylimino)bisethanol CAS 13127-82-7, would be expected to have more potential then the 2, 2’-(C12-18 evennumbered alkyl imino) diethanol CAS No 71786-60-2. Therefore read across to this substance is considered to be very unlikely to underestimate any skin sensitisation potential of 2, 2’-(C12-18 evennumbered alkyl imino) diethanol. Any potential reactivity involving the amine part of the molecule either directly or following metabolism in the skin would be expected to be very similar for both substances. Based on this, in the absence of any specific data on 2, 2’-(C12-18 evennumbered alkyl imino) diethanol CAS No 71786-60-2 and the difficulty in providing this data due to animal welfare considerations in testing a corrosive substance, read across has been used to the data available for(Z)-2,2’-(Octadec-9-enylimino)bisethanol CAS 13127-82-7.


 


 


The potential of the test item (Z)-2,2’-(Octadec-9-enylimino)bisethanol CAS 13127-82-7 to induce delayed contact hypersensitivity was evaluated in guinea pigs according to the maximization method of Magnusson and Kligman and to OECD (No. 406, 17th July 1992) and EC (96/54/EEC, B.6, 30th July 1996) guidelines. The study was conducted in compliance with the principles of Good Laboratory Practice Regulations.


 


Based on preliminary testing, where only a dose of 0.1% of the test substance was well tollerated with acceptable effects at the injection site, this concentration was used for the intradermal induction the test item at the concentration of 0.1% in corn oil (treated group) or vehicle alone (control group), the test item at the concentration of 0.1% in a mixture FCA/0.9% NaCl (50/50, w/w) (treated group) or vehicle at the concentration of 50% (w/v) in a mixture FCA/0.9% NaCl (50/50, v/v) (control group) were administered.


 


On day 8, the animals of the treated group received a topical application of the test item at the concentration of 10% (w/w) in ethanol/water (80/20) to the same test site, which was then covered by an occlusive dressing for 48 hours. The animals of the control group received an application of the vehicle under the same experimental conditions.


 


On day 22, all animals of both groups were challenged by a cutaneous application of the test item at the concentration of 1% (w/w) in acetone to the right flank. The test item was maintained under an occlusive dressing for 24 hours. The vehicle was applied to the left flank under the same experimental conditions. Skin reactions were evaluated approximately 24 and 48 hours after removal of the dressing.


 


As the doses used were selected based on the criteria in the OECD guideline the study is considered to be valid.


 


No systemic clinical signs and no deaths were noted during the study. No relevant cutaneous reactions were observed after the challenge application.


 


Under the experimental conditions and according to the maximization method of Magnusson and Kligman, the test substance (Z)-2,2’-(Octadec-9-enylimino)bisethanol CAS 13127-82-7, does not induce delayed contact hypersensitivity in guinea pigs.


 


 


 


Addtionally, 2, 2’-(C12-18 evennumbered alkyl imino) diethanol CAS No 71786-60-2 was shown to be negative in Derek Nexus QSAR for skin sensitization following the protocol of OECD 497 ITS V1 and was considered non-skin sensitizer for all species. As the full OECD 497 was not performed on the substance conclusions can not be made from this QSAR alone, however it is strong weight of evidence and sufficent bridging information for this endpoint.


 


Migrated from Short description of key information:


There are no studies on skin sensitisation in animals available for 2, 2’-(C12-18 evennumbered alkyl imino) diethanol CAS No 71786-60-2.  The skin irritation study in rabbits showed the test substance to be corrosive, which makes it very difficult to perform animal studies for skin sensitisation due to animal welfare considerations.  


 


There is data on a similar substnace (Z)-2,2’-(Octadec-9-enylimino)bisethanol CAS 13127-82-7. The potential of the test item (Z)-2,2’-(Octadec-9-enylimino)bisethanol CAS 13127-82-7 to induce delayed contact hypersensitivity was evaluated in guinea pigs according to the maximization method of Magnusson and Kligman and to OECD (No. 406, 17th July 1992) and EC (96/54/EEC, B.6, 30th July 1996) guidelines to GLP.  (Z)-2,2’-(Octadec-9-enylimino)bisethanol CAS 13127-82-7, did not induce delayed contact hypersensitivity in guinea pigs.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Read across to (Z)-2,2’-(Octadec-9-enylimino)bisethanol CAS 13127-82-7 is considered to be very unlikely to underestimate any skin sensitisation potential of 2, 2’-(C12-18 evennumbered alkyl imino) diethanol. Any potential reactivity involving the amine part of the molecule either directly or following metabolism in the skin would be expected to be very similar for both substances. Based on this, in the absence of any specific data on 2, 2’-(C12-18 evennumbered alkyl imino) diethanol CAS No 71786-60-2 and the difficulty in providing this data due to animal welfare considerations in testing a corrosive substance, read across has been used to the data available for(Z)-2,2’-(Octadec-9-enylimino)bisethanol CAS 13127-82-7.

 

There are no guidelines for an animal test for respiratory sensitisation, however in general respiratory sensitisers are also skin sensitisers. The lack of any indication of skin sensitisation in the OECD 406 GLP compliant study on (Z)-2,2’-(Octadec-9-enylimino)bisethanol CAS 13127-82-7, indicates that it is unlikely to be a respiratory sensitiser. This also indicates that 2, 2’-(C12-18 evennumbered alkyl imino) diethanol CAS No 71786-60-2 is also unlikely to be a respiratory sensitiser.

Migrated from Short description of key information:

There are no guidelines for an animal test for respiratory sensitisation, however in general respiratory sensitisers are also skin sensitisers.  The lack of any indication of skin sensitisation in the OECD 406 GLP compliant study on (Z)-2,2’-(Octadec-9-enylimino)bisethanol CAS 13127-82-7, indicates that it is unlikely to be a respiratory sensitiser. Based on this it is not expected that 2, 2’-(C12-18 evennumbered alkyl imino) diethanol CAS No 71786-60-2 would cause respiratory sensitisation.

Justification for classification or non-classification

The read-across substance ((Z)-2,2’-(Octadec-9 -enylimino)bisethanol CAS 13127 -82 -7) was not found to be a skin sensitiser when tested in the OECD 406 study, this indicates that it is unlikely to posses any significant potential for respiratory sensitisationThe physical form of this substance a liquid with a low vapour pressure means inhalation exposure will be minimal. Based on this information it is not classified as a respiratory sensitiser.


Addtional evidence via QSAR indicates that 2, 2’-(C12-18 evennumbered alkyl imino) diethanol CAS No 71786-60-2 will be a non-sensitizer to skin. Based on available evidence it is therefore not necesare to classify 2, 2’-(C12-18 evennumbered alkyl imino) diethanol CAS No 71786-60-2 as sensitising to skin.