Registration Dossier

Administrative data

Description of key information

Not sensitising

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Remarks:
predates the adoption of the REACH legislation and the development of the LLNA and in vitro methods.
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1963-1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
The analogue approach is used for the hazard assessment of toxicological endpoints for the registration of 2-hydroxyethyl ricinoleate (CAS 106-17-2) based on generation of different breakdown/metabolic products resulting in similar physical and biological systems (Scenario 2 of the Read-Across Assessment Framework (RAAF, ECHA, 2017). Read-across is applied from glycol stearate (CAS 111-60-4) and ethylene glycol distearate (CAS 627-83-8), and a non-hydroxyl ester, methyl ricinoleate (CAS 141-24-2). The first two of these provide hazard information on the glycol portion of the substance; the latter on the ricinoleate function. The different alcohols resulting from ester hydrolysis of the source compounds and the target substance will not result in significant variation in biological effects.

The glycol stearate was found to be negative (non-sensitising) in an experimental guinea pig model as well as in human clinical studies (patch testing and evaluation over 45 days. Ethylene glycol distearate was tested in guinea pigs and found to be negative (Jones, 1984). Methyl ricinoleate was also negative in a guinea pig Buehler protocol (Manciaux, 1999). There is high confidence that the registered (target) substance is not sensitizing.

Read-across among the analogues is substantiated as valid and is adequate to fulfill the information requirements of Annex IX, to be the basis for classification and labelling decisions, and for risk assessment.
Reason / purpose:
read-across source
Qualifier:
no guideline followed
Principles of method if other than guideline:
Intradermal injections only were used for both induction and challenge exposures
GLP compliance:
not specified
Type of study:
Buehler test
Justification for non-LLNA method:
Test predates adoption of LLNA as standard method
Species:
guinea pig
Strain:
not specified
Sex:
male
Route:
intradermal
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.05 ml
Day(s)/duration:
Initial injection on Day 1
Adequacy of induction:
not specified
Route:
intradermal
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.1 mL
Day(s)/duration:
Three times a week for a total of ten injections
Adequacy of induction:
not specified
No.:
#1
Route:
intradermal
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.1 ml
Day(s)/duration:
24 hours
Adequacy of challenge:
not specified
No. of animals per dose:
2
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10
- Exposure period: 3 weeks
- Test groups: 1 group of 2 white male guinea pigs
- Control group: not specified
- Site: shaved back
- Frequency of applications: 3 injections/week
- Duration: 3 weeks
- Concentrations: Initial injection was 0.05 mL, following injections were 0.1 mL

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 1
- Exposure period: 2 weeks
- Site: shaved back
- Concentrations: not specified
- Evaluation (hr after challenge): 24

OTHER:
Positive control substance(s):
not specified
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
0.1 ml
No. with + reactions:
0
Total no. in group:
2
Clinical observations:
not specified
Remarks on result:
no indication of skin sensitisation

Not sensitising in a protocol which used intradermal injection only for both induction and challenge. No epicutaneous exposure is noted.

Interpretation of results:
GHS criteria not met
Conclusions:
The analogue test substance is nonsensitising in this assay. This summary data reflects the opinion of the CIR Expert Panel that the data are valid and informative, adding to a weight of evidence demonstrating that the source and target substances lack potential to be skin sensitisers.
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:
18 March 1999-19 April 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
The analogue approach is used for the hazard assessment of toxicological endpoints for the registration of 2-hydroxyethyl ricinoleate (CAS 106-17-2) based on generation of different breakdown/metabolic products resulting in similar physical and biological systems (Scenario 2 of the Read-Across Assessment Framework (RAAF, ECHA, 2017). Read-across is applied from glycol stearate (CAS 111-60-4) and ethylene glycol distearate (CAS 627-83-8), and a non-hydroxyl ester, methyl ricinoleate (CAS 141-24-2). The first two of these provide hazard information on the glycol portion of the substance; the latter on the ricinoleate function. The different alcohols resulting from ester hydrolysis of the source compounds and the target substance will not result in significant variation in biological effects.

The glycol stearate was found to be negative (non-sensitising) in an experimental guinea pig model as well as in human clinical studies (patch testing and evaluation over 45 days. Ethylene glycol distearate was tested in guinea pigs and found to be negative (Jones, 1984). Methyl ricinoleate was also negative in a guinea pig Buehler protocol (Manciaux, 1999). There is high confidence that the registered (target) substance is not sensitizing.

Read-across among the analogues is substantiated as valid and is adequate to fulfill the information requirements of Annex IX, to be the basis for classification and labelling decisions, and for risk assessment.
Reason / purpose:
read-across source
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The LLNA guideline study was not validated at the time the ginea pig was performed (1999).
Species:
guinea pig
Sex:
male/female
Details on test animals and environmental conditions:
Animals
Species and strain: Dunkin-Hartley guinea-pigs.
Reason for this choice: species generally accepted by regulatory authorities for this type of study. The strain used bas been shown to produce a satisfactory sensitization response using known positive sensitizers.
Breeder: Charles River France, 76410 Saint-Aubin-lès-Elbeuf, France. Number: . one male and one female for the preliminary test,
. 30 animais (15 males and 15 females) for the main test.
Females were nulliparous and non-pregnant.
Allocation of the animais to the groups: on day -1, the animais were weighed and randomly allocated to two groups: a control group 1 consisting of ten animais (five males and five females) and a treated group 2 consisting of 20 animais (ten males and ten females).
Weight: on day 1, the animais of the main test were approximately 3 months old and had a mean body weight ± standard deviation of 382 ± 14 g for the males and 357 ± IO g for the females.
Acclimatization: at Ieast 5 days before the beginning of the study. Identification of the animais: ear-tattoo.

Environmental conditions
The conditions in the animal room were set as follows:
. temperature: 21 ± 2°C
.relative humidity: 30 to 70%
. light/dark cycle: 12 h/12 h
. ventilation: approximately 12 cycles/heur of filtered, non-recycled air.
The temperature and relative humidity were under continuous control and recording. The records were checked daily and filed. In addition to these daily checks, the housing conditions and corresponding instrumentation and equipment are verified and calibrated at regular intervals.
During the acclimatization period and throughout the study, the animais were housed individually in polycarbonate cages (48 cm x 27 cm x 20 cm) equipped with a polypropylene bottle.
Dust-free sawdust was provided as litter (SICSA, 92142 Alfortville, France).
Bacteriological and chemical analyses of the sawdust, including the detection of possible contaminants (pesticides, heavy metals), are performed regularly by externat laboratories.
The results of these analyses are archived at CIT.

Food and water
During the study, the animals had free access to "106 pelleted diet" (UAR, 91360 Villemoisson­ sur-Orge, France).
Food is analysed regularly by the supplier for composition and contaminant levels. The diet formula is presented in appendix 2.

Drinking water filtered by a FG Millipore membrane (0.22 micron) was provided ad libitum. Bacteriological and chemical analyses of the water and diet, including the detection of possible contaminants (pesticides, heavy metals and nitrosamines), are performed regularly by extemal laboratories.
The results of these analyses are archived at CIT.

No contaminants were known to have been present in the diet, drinking water or bedding material at levels which may be expected to have interfered with or prejudiced the outcome of the study.


Route:
intradermal
Vehicle:
corn oil
Concentration / amount:
25%
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0,5ml
Day(s)/duration:
24h
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0,5 ml
Day(s)/duration:
24 hours
Adequacy of challenge:
not specified
No. of animals per dose:
5 males and 5 females (controls), 10 males and 10 females (treated)
Details on study design:
Thirty guinea-pigs were allocated to two groups: a control group 1 (five males and five females) and a treated group 2 (ten males and ten females).

On day l, intradermal injections of Freund's complete adjuvant mixed with the test substance (treated group) or the vehicle (control group) were performed in the interscapular region.

On day 7, the same region received a topical application of sodium lauryl sulfate in vaseline (10%, w/w) in order to induce local irritation.

On day 8, the test substance (treated group) or the vehicle (control group) was applied to the same test site which was then covered by an occlusive dressing for 48 hours.

On day 22, after a rest period of 12 days, ail animais of the treated and control groups were challenged by a cutaneous application of the test substance to the right flank. The left flank served as control and received the vehicle only. Test substance and vehicle were maintained under an occlusive dressing for 24 hours.
Skin reactions were evaluated approximately 24 and 48 hours after removal of the dressing. Test substance concentrations were as follows:
Induction (treated group)
intradermal injections: RICINOLEATE DE METHYLE at the concentration of 25% (w/w) in corn oil,
. topical application: RICINOLEATE DE METHYLE undiluted.

Challenge (all groups)
. topical application: RICINOLEATE DE METHYLE undiluted.


At the end of the study, animais were killed without examination of internai organs. No skin samples were taken from the challenge application sites.

The sensitivity of the guinea-pigs in CIT experimental conditions was checked with a positive sensitizer, 2,4-Dinitro Chlorobenzene (DNCB). During the induction period, the reference substance DNCB was applied at the concentrations of 0.1% (w/w) (day 1) and 1% (w/w) (day 8) in corn oil. For the challenge application, the reference substance DNCB was applied at the concentration of 1% (w/w) in corn oil.
Challenge controls:
Challenge (all groups)
. topical application: RICINOLEATE DE METHYLE undiluted.

Positive control substance(s):
yes
Positive control results:
The species and strain which were used showed a satisfactory sensitization response in 90% animais treated with DNCB.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
25%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
very slight erythema observed in 1/10 controls and 5/20 treated animals
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
25%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation

 Clinicat examinations

No clinicat signs and no mortality were observed during the study.

 

The body weight gain of the treated animals was normal when compared to that of the control animals (figures2and3,appendix3).

 

Scoringofcutaneousreactions

 End of the induction period

On day10,after the cutaneous application  of the induction period, signs of irritation  were observed at the interscapular test site in the control and treated groups.

Scoring of skin reactions was as follows:

 

Sex          Animal


Controlgroup

----------24-h-ou-r-s--------------------48-h-ou-r-s----------


 

LF

RF

LF

RF

LF

RF

LF

RF

Male

31

0

0

0

0

OIS

OIS

0

0

 

32

0

0

0

0

0

0

0

0

 

33

0

0

0

0

0

0

0

0

 

34

0

0

0

0

0

OIS

0

0

 

35

0

0

0

0

OIS

OIS

0

0

Female

46

0

0

0

0

0

OIS

0

0

 

47

0

0

0

0

0

0

0

0

 

48

0

0

0

0

0

OIS

0

0

 

49

0

0

0

0

0

0

0

0

 

50

0

 

0

0

0

OIS

0

0

Treatedgroup

 

number               Erythema                         Oedema                         Erythema                         Oedema

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


 

Sex          Animal


-----------24-h-ou-r-s--------------------48-h-ou-r-s----------


number               Erythema                         Oedema                         Erythema                         Oedema

 

 

LF

RF

LF

RF

LF

RF

LF

RF

Male

36

0

1

0

0

0

OIS

0

0

 

37

0

0

0

0

0

OIS

0

0

 

38

0

0

0

0

0

OIS

0

0

 

39

0

0

0

0

0

0

0

0

 

40

0

0

0

0

0

0

0

0

 

41

0

 

0

0

0

OIS

0

0

 

42

0

l

0

0

0

OIS

0

0

 

43

0

0

0

0

0

0

0

0

 

44

0

0

0

0

OIS

OIS

0

0

 

45

0

0

0

0

0

0

0

0

Female

51

0

0

0

0

0

OIS

0

0

 

52

0

l

0

0

0

OIS

0

0

 

53

0

0

0

0

0

0

0

0

 

54

0

0

0

0

0

0

0

0

 

55

0

0

0

0

0

0

0

0

 

56

0

0

0

0

0

0

0

0

 

57

0

0

0

0

OIS

0

0

0

 

58

0

0

0

0

0

0

0

0

 

59

0

l

0

0

OIS

OIS

0

0

 

60

0

0

0

0

0

OIS

0

0

LF:leftflank(vehicle)

RF:rightflank(undilutedtestsubstance)

s :drynessoftheskin

Interpretation of results:
GHS criteria not met
Conclusions:
Ricinoleate de méthyle is not a skin sensitizer according to the OECD 406 guideline study.
Executive summary:

The sensitization potential of the test substance RICINOLEATE DE METHYLE was evaluated in the Guinea-pig according to the maximization procedure by Magnusson and Kligman. 20 Dunkin-Hartley guinea pigs (10 males and 10 females) were treated in the test group. The test substance was applied by intradermal injection at a concentration of 25% in corn oil, after 9 days, the animals were induced (and irritation by sodium lauryl sulfate in vaseline) epicutanously by the undiluted test item. On day 22, after a restperiod of 12days,treated animals and controls were challenged by a cutaneous application of the test substance to the right flank The left flank served as control and received the vehicle  only . Test substance and vehicle were maintained under an occlusive dressing for 24hours.

Skinreactions were evaluated approximately 24and 48hours after removal of the dressing.

No symptoms, mortality or cutaneaous reactions due to any sensitization process by treatment with the test substance, RICINOLETATE DE METHYLE , were observed in guinea pigs.

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:
From Nov. 1983 to Jan. 1984
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Remarks:
(OECD guideline 406)
Justification for type of information:
The analogue approach is used for the hazard assessment of toxicological endpoints for the registration of 2-hydroxyethyl ricinoleate (CAS 106-17-2) based on generation of different breakdown/metabolic products resulting in similar physical and biological systems (Scenario 2 of the Read-Across Assessment Framework (RAAF, ECHA, 2017). Read-across is applied from glycol stearate (CAS 111-60-4) and ethylene glycol distearate (CAS 627-83-8), and a non-hydroxyl ester, methyl ricinoleate (CAS 141-24-2). The first two of these provide hazard information on the glycol portion of the substance; the latter on the ricinoleate function. The different alcohols resulting from ester hydrolysis of the source compounds and the target substance will not result in significant variation in biological effects.

The glycol stearate was found to be negative (non-sensitising) in an experimental guinea pig model as well as in human clinical studies (patch testing and evaluation over 45 days. Ethylene glycol distearate was tested in guinea pigs and found to be negative (Jones, 1984). Methyl ricinoleate was also negative in a guinea pig Buehler protocol (Manciaux, 1999). There is high confidence that the registered (target) substance is not sensitizing.

Read-across among the analogues is substantiated as valid and is adequate to fulfill the information requirements of Annex IX, to be the basis for classification and labelling decisions, and for risk assessment.
Reason / purpose:
read-across: supporting information
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
no
Type of study:
Buehler test
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hacking and Churchill, Abbots Ripton road, Wyton, Huntingdon, PE17 2PT
- Age at study initiation: Not reported
- Weight at study initiation: 251-308 g
- Housing: Animals were housed in a single air conditioned room and were kept in grid floor polypropylene cages in groups of 2 by sex
- Diet: Guinea pig diet, standard with vitamin C, special diets services ltd., Stepfield, Witham, Essex; ad Libitum
- Water: Mains drinking water; ad libitum (Clean water bottles were provided each week)
The diet and drinking water were considered not to contain any contaminant at a level that might have affected the purpose or integrity of the study.
- Acclimation period: At least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature: 15-22°C
- Relative Humidity: 30-63%
- Air changes: Not reported
- Photoperiod: 12 hours artificial light and 12 hours darkness

Route:
epicutaneous, occlusive
Vehicle:
paraffin oil
Concentration / amount:
100% w/v test material (0.5 mL)
Day(s)/duration:
On day 1,8 and 15
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
paraffin oil
Concentration / amount:
100% w/v test material (0.5 mL)
Day(s)/duration:
Day 29; 2 weeks after 3 induction exposure
No. of animals per dose:
20 test animals and 10 control animals
Details on study design:
RANGE FINDING TESTS: The day before treatment, the backs of the guinea pigs were clipped to be free of hair using electric clippers. The test substance (using 4 concentrations) was applied for 6 hours under a lint pad (19 mm × 25 mm) on an Elastoplast coverlet (38 mm × 50mm) to 4 sites on the shaven back of each of 2 guinea pigs (1 male and 1 female). The skin sites were evaluated 24 hours after treatment and the highest non-irritant concentration was used for the main study.
- Concentration: 100%, 50%, 25% and 10% w/v test material in liquid paraffin.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Test groups: One test group, including 20 guinea pigs
- Control group: One control group including 10 guinea pigs (exposed with only 0.5 mL liquid paraffin)
- Site: Left flank of each animal
- Frequency of applications: Once each week for 3 weeks
- Duration: 3 weeks
Concentrations: 100% w/v test substance in liquid paraffin (0.5 mL)
- Procedure for application: A lint pad (2.5 cm*2.5 cm) wetted with test substance in liquid paraffin was applied to the left flank of each of 20 test guinea pigs for a contact period of 6 hours. The lint pads were held in place with an overlapping impermeable occlusive tape (Sleek, Smith and Nephew Ltd., Welwyn garden city, Herts) and secured by elastic adhesive bandage (Elastoplast, Smith and Nephew Ltd., Welwyn garden city, Herts) placed around the torso of animals. The treatment was repeated on Day 8 and Day 15 on the same site (which was shaved a day before each application). An identical patch wetted with liquid paraffin only was applied to 10 control animals on the left flank.
B. CHALLENGE EXPOSURE
- No. of exposures: One
- Day(s) of challenge: 2 weeks after the 3rd induction exposure (Day 29)
- Exposure period: 6 hours
- Test groups: One test group (20 animals) exposed with 0.5 mL of 100% w/v test material in liquid
paraffin on the right flank and with only liquid paraffin on the left flank.
- Control group: One control group (10 animals) exposed with 0.5 mL of 100% w/v test material in liquid paraffin on the right flank and with only liquid paraffin on the left flank.
- Site: test substance in liquid paraffin (right flank) and liquid paraffin only (left flank)
- Concentrations: 100% w/v test substance in liquid paraffin
- Evaluation (hour after challenge): On the day following challenge application, all the animals were treated with depilatory cream on the challenge site, rinsed thoroughly and dried with a disposable paper towel. Three hours after depilation, the challenge sites were evaluated. The evaluation was repeated 24 hour later (45 hour reading).
Challenge controls:
10 control animals were treated with 0.5 mL of 100% w/v test material in liquid paraffin on the right flank
and only liquid paraffin on the left flank.
Positive control substance(s):
not required
Positive control results:
No positive control was reported in the study
Key result
Reading:
1st reading
Hours after challenge:
21
Group:
test group
Dose level:
100% w/v test material
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No animals with positive response
Key result
Reading:
1st reading
Hours after challenge:
21
Group:
negative control
Dose level:
100% w/v test material
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No animals with positive response
Key result
Reading:
2nd reading
Hours after challenge:
45
Group:
test group
Dose level:
100% w/v test material
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No animals with positive response
Key result
Reading:
2nd reading
Hours after challenge:
45
Group:
negative control
Dose level:
100% w/v test material
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No animals with positive response

Table 1: Skin reaction in screening study (Study # 29573)

(Concentration%w/v)

No. of animals showing skin response (scale 0-3)

0 0.5 1 2 3
100 2 0 0 0 0
50 2 0 0 0 0
25 2 0 0 0 0
10 2 0 0 0 0

Table 2: The incidence and severity of skin reaction observed in test and control group (Study# 29573)

Experimental group Test site Observation time (hours) Skin responses (scale 0-3) Incidence Severity
0 0.5 1 2 3 (N) (A)

Test

L 21 19 1 0 0 0 0/20 0
45 20 0 0 0 0 0/20 0
R 21 19 1 0 0 0 0/20 0
45 20 0 0 0 0 0/20 0

Control

L 21 9 1 0 0 0 0/10 0.1
45 10 0 0 0 0 0/10 0
R 21 9 1 0 0 0 0/10 0.1
45 10 0 0 0 0 0/10 0

L = Left flank treated with vehicle

R = Right flank treated with 100% test substance

Summary of skin sensitization study:

At 21 hours: Test animals – Slight patchy erythema (0.5) was observed in 1/20 animals

Control animals - Slight patchy erythema (0.5) was observed in 1/10 animals

At 45 hours: No skin reaction was observed in all animals

None of the skin reaction in test group animals observed after primary challenge applications exceeded the most severe control reaction (grade0.5).

Interpretation of results:
GHS criteria not met
Remarks:
(not sensitising)
Conclusions:
EGDS ex. Henkel (ethylene distearate) was determined to be non-sensitizing in a delayed hypersensitivity (Buehler) test when applied topically to Dunkin-Hartley Guinea pigs.
Executive summary:

The skin sensitization potential of EGDS ex. Henkel was determined following a method comparable to OECD Guideline 406 (Skin Sensitisation).

 A total of 32 guinea pigs (16 male and 16 female) were obtained from Hacking and Churchill, Huntingdon. The body weight of animals was between 251-308 grams. Animals were acclimated for at least 7 days prior to initiation of treatment and were housed in groups of 2, by sex, in grid floor polypropylene cages under standard laboratory conditions (15-22°C; relative humidity: 30-63% and photoperiod: 12 hours artificial light and 12 hours darkness).

 Prior to the main study, a range finding study was conducted to determine the highest non-irritating concentration which could be applied for the primary challenge. The test concentrations were tested at concentrations of 100%, 50%, 25% and 10% w/v in liquid paraffin. The concentration selected for challenge application was 100% w/v in liquid paraffin. The study was conducted in two phases, induction exposure and primary challenge exposure. On day of induction, 100% w/v test substance in liquid paraffin was applied as occlusive patch on left flank. The treatment was repeated on Day 8 and Day 15 on the same site. An identical patch wetted with liquid paraffin only was applied to 10 control animals on the left flank. Two weeks after induction phase (Day 29), the test animals were challenged by application of occlusive patch of 100% test substance on the right flank and vehicle alone patch on left flank. After 6 hours, the patched were removed. On the day following challenge application, sites were depilated and the challenge sites were evaluated. The evaluation was repeated 24 hour later (45 hour reading). The control animals received an identical application of the test solution or vehicle on Day 29 using the same procedure as for the treatment group. Slight patchy erythema (grade: 0.5) was observed in 1/20 animals after 21 hours of challenge exposure in treatment and control animals while no skin reaction was observed after 45 hours of challenge exposure in any animals. None of the skin reactions in test group animals observed after primary challenge applications exceeded the most severe control reaction (grade0.5).

EGDS ex. Henkel (ethylene distearate) was determined to be non-sensitizing in a delayed hypersensitivity (Buehler) test when applied topically to Dunkin-Hartley Guinea pigs. This skin sensitization study is classified as acceptable, and satisfies the guideline requirement of OECD 406 (Skin Sensitisation).

 

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

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Analogue test materials were evaluated for skin sensitisation potential and observed to be non sensitising to the skin.

For the target substance, GHS criteria (Regulation EC No. 1272/2008) for classification as a skin sensitiser are not met.