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Administrative data

Description of key information

The assessment of skin sensitization property of the registration substance is derived based on the read-across approach.
2,2'-(octadec-9-enylimino) bisethanol CAS 25307-17-9, was tested for its skin sensitization property according to OECD 406 Test Guideline. No significant skin sensitization property was found. Likewise, no skin sensitization property is expected for the registration substance.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
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 registration substance is a surfactant.
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.
Key result
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:
no indication of skin sensitisation
Key result
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:
no indication of skin sensitisation
Key result
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:
no indication of skin sensitisation
Key result
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:
no indication of skin sensitisation
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:
GHS criteria not met
Conclusions:
The skin sensitization property of the registration substance is derived based on the read-across approach.
2,2'-(octadec-9-enylimino) bisethanol CAS 25307-17-9, was tested for its skin sensitization property according to OECD 406 Test Guideline. No significant skin sensitization property was found.
Executive summary:

The skin sensitization property of the registration substance is derived based on the read-across approach.

2,2'-(octadec-9-enylimino) bisethanol CAS 25307-17-9, was tested for its skin sensitization property according to OECD 406 Test Guideline. The applied induction doses were 0.1% for intradermal- and 10% for topical treatment and the applied challenge dose was 1%. No response was observed in twenty treated animals and in ten control animals. No significant skin sensitization property was found.

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

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

No data is available for the assessment of respiratory sensitization. Taking account that no significant skin sensitization can be reliably derived and that the registration is of low volatily, no significant hazard for the respiratory sensitization can be derived. No classification is justified for the endpoint respiratory sensitization.

Justification for classification or non-classification

The assessment of the skin sensitization property of the registration substance is based on the read-across approach.

2,2'-(octadec-9-enylimino) bisethanol CAS 25307-17-9, was tested for its skin sensitization property according to OECD 406 Test Guideline. No significant skin sensitization property was found. Likewise, no skin sensitization property is expected for the registration substance and no classification is justified for the endpoint skin sensitization.

No data is available for the assessment of respiratory sensitization. Taking account that no significant skin sensitization can be reliably derived and that the registration is of low volatily, no significant hazard for the respiratory sensitization can be derived. No classification is justified for the endpoint respiratory sensitization.