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Diss Factsheets

Administrative data

Description of key information

In a Beuhler assay to evaluate the sensitisation potential a structurally similar substance (100% w/v in liquid paraffin) was administered topically to guinea pigs (20 animals/concentration) for a 6 hour period 3 times over 21 days. Twenty nine days after the first induction dose, a challenge dose of the substance at its highest non-irritating concentration (100% w/v) was applied to a naive site on each guinea pig. A naive control group (ten animals) was maintained under the same environmental conditions and treated with the substance at challenge only. The animals were scored for erythema approximately 21 hours and 45 hours after each induction and challenge dose. Based on the results of this study, the substance is not considered to be a contact sensitiser.

In a Guinea pig maximisation assay to evaluate the sensitisation potential a structurally similar substance was injected intradermally into the shaven back of each of two male, white guinea pigs. Following an initial 0.05 ml injection, 0.1 ml injections were given three times a week for a total of ten injections. Two weeks later a challenge injection was given, and readings were taken 24 hours later. Based on the results of this study, the substance is not considered to be a skin sensitiser.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Remarks:
Read-across to K1 study therefore K2 is the maximum Klimisch value.
Justification for type of information:
Read-across approach - see read-across justification in section 13.
Reason / purpose for cross-reference:
read-across source
GLP compliance:
no
Remarks:
Testing was conducted prior to the implementation of GLP in Europe.
Type of study:
Buehler test
Justification for non-LLNA method:
The testing was conducted in 1983-1984.
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
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 animals were used for the main study exposed to the substance.
10 animals were used for the main study exposed to the vehicle only and served as controls.
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 chemical
Dose level:
100% w/v test material
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No animals with positive response
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
45
Group:
test chemical
Dose level:
100% w/v test material
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No animals with positive response
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No animals with positive response
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
45
Group:
negative control
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No animals with positive response
Remarks on result:
no indication of skin sensitisation

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
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:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Remarks:
Read-across to K2 study therefore K2 is the maximum Klimisch value.
Justification for type of information:
Read-across approach - see read-across justification in section 13.
Reason / purpose for cross-reference:
read-across source
Principles of method if other than guideline:
The substance was injected intradermally into the shaven back of each of two male, white guinea pigs. Following an initial 0.05 ml injection, 0.1 ml injections were given three times a week for a total often injections. Two weeks later a challenge injection was given, and readings were taken 24 hours later.
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The details of the study were taken from a publication intended for the use of the substance as a cosmetic ingredient.
Species:
guinea pig
Strain:
not specified
Sex:
male
Route:
intradermal
Vehicle:
not specified
Concentration / amount:
Following an initial 0.05 ml injection, 0.1 ml injections were given three times a week for a total of ten injections.
Day(s)/duration:
3 weeks
Adequacy of induction:
not specified
No.:
#1
Route:
intradermal
Vehicle:
not specified
Concentration / amount:
Not specified.
Day(s)/duration:
Single administration two after the last induction injection was administered.
Adequacy of challenge:
not specified
No. of animals per dose:
Two.
Positive control substance(s):
not specified
Positive control results:
Not stated.
Key result
Reading:
other:
Hours after challenge:
24
Group:
test chemical
No. with + reactions:
0
Total no. in group:
2
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
GHS criteria not met
Conclusions:
Based on the results of a Guinea pig maximisation assay, the substance is not considered to be a skin sensitiser.
Executive summary:

In a Guinea pig maximisation assay to evaluate the sensitisation potential the substance was injected intradermally into the shaven back of each of two male, white guinea pigs. Following an initial 0.05 ml injection, 0.1 ml injections were given three times a week for a total of ten injections. Two weeks later a challenge injection was given, and readings were taken 24 hours later. Based on the results of this study, the substance is not considered to be a skin sensitiser.

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

Based on the findings of an in vivo skin sensitisation study in Guinea pigs conducted on a structurally similar substance, classification of the substance is not justified.