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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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Administrative data

Description of key information

The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the polyol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly.


For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the polyol esters category.


 


Skin sensitisation (OECD 406, GPMT and Buehler; human repeated insult patch test): not skin sensitising


Read-across from structural analogue source substances Dipentaerythritol hexaesters with fatty acids, C5 and C9iso (CAS No. 647028-25-9), Pentaerythritol tetraesters of n-decanoic, n-heptanoic, n-octanoic and n-valeric acids (CAS No. 68424-31-7), Fatty acids, C5-9 tetraesters with pentaerythritol (CAS No. 67762-53-2), and Fatty acids, C8-10 mixed esters with dipenaterythritol, isooctanoic acid, pentaerythritol and tripentaerythritol (CAS No. 189200-42-8)

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:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
use of an irritating dose for challenge exposure; lack of data on test substance
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
(use of an irritating dose for challenge exposure; lack of data on test substance)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
A non-LLNA test is available that was performed prior to the current data requirements, stipulated in Regulation (EC) No 1907/2006. In accordance with the same Regulation, the data were included to avoid unnecessary testing.
Species:
guinea pig
Strain:
other: Hartley Albino
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories, Raleigh, NC, USA
- Age at study initiation: ca. 5 weeks
- Weight at study initiation: 286 - 342 g
- Housing: animals were housed separately in suspended stainless steel and wire mesh cages with absorbent paper below the cages.
- Diet: Agway PROLAB Certified Guinea Pig Chow, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 9 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 22
- Humidity (%): 40 - 70
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES:
From: 14 Sep 1995
To: 16 Oct 1995
Route:
intradermal and epicutaneous
Vehicle:
other: peanut oil, FCA
Concentration / amount:
intradermal: 5%
epicutaneous: 100%
Route:
epicutaneous, occlusive
Vehicle:
other: peanut oil, FCA
Concentration / amount:
50%
No. of animals per dose:
10 irritation control animals, 10 positive control animals, 20 animals in test groups
Details on study design:
RANGE FINDING TESTS:
A primary irritation test (PIT) was performed to determine suitable concentrations for intradermal and epicutaneous induction. Therefore, three concentrations of the test substance (0.1, 1.0 and 5.0% v/v in peanut oil) were administered intradermally to 2 animals per concentration. The injection sites were evaluated 24 and 48 h after injection. None of the injection sites for the 5.0% animals showed skin corrosion or irritation at either the 24 or 48 h observations. Therefore, 5% of the test substance was chosen for intradermal induction. The PIT also indicated that 100% of the test substance applied topically produced mild to moderate irritation whereas 50% of the test substance was non-irritating. Therefore, concentrations of 100% of the test substance were chosen for the topical induction dose and 50% for the challenge dose, respectively.

MAIN STUDY
A. INDUCTION EXPOSURE
On Day 0, 3 pairs of intradermal injections (0.1 mL) were made in the shoulder region of the test animals. On Day 7, 100% of the test substance (0.5 mL) was applied topically under occlusive conditions for 48 h on the shoulder region of the test animals.
- Exposure period: 3 single injections (intradermal) and 48 h (epicutaneous)
- Test groups:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture (v/v) FCA/water
Injection 2: 5% (v/v) test substance in peanut oil
Injection 3: 5% (v/v) test substance in a 1:1 mixture (v/v) FCA/water

Epicutaneous: test substance (0.5 mL, occlusive conditions)

Evaluation: 1 and 24 h after each induction

- Control group:
Injection 1: a 1:1 mixture (v/v) FCA/water
Injection 2: peanut oil
Injection 3: peanut oil in a 1:1 mixture (v/v) FCA/water

Epicutaneous: peanut oil (0.5 mL, occlusive conditions)

Evaluation: 1 and 24 h after each induction

B. CHALLENGE EXPOSURE
On Day 21, the test substance in peanut oil (50% (v/v, 0.4 mL) was applied topically under occlusive conditions for 24 h to all animals.
- No. of exposures: 1
- Exposure period: 24 h
- Test groups: test substance in peanut oil (left flank) and peanut oil only (right flank)
- Control group: test substance in peanut oil (left flank) and peanut oil only (right flank)
- Evaluation (hr after challenge): 24 and 48 h

Due to the fact that the challenge dosing with 50% test substance was more irritating than is ideal for the challenge and rechallenge phases, the concentration for rechallenge dosing was lowered to 10% of the test substance.

C. RECHALLENGE EXPOSURE
On Day 28, the test substance in peanut oil (10% (v/v, 0.4 mL) was applied topically under occlusive conditions for 24 h to all animals.
- No. of exposures: 1
- Exposure period: 24 h
- Test groups: test substance in peanut oil (right flank) and peanut oil only (left flank)
- Control group: test substance in peanut oil (right flank) and peanut oil only (left flank)
- Evaluation (hr after rechallenge): 24 and 48 h after patch removal
Challenge controls:
The control group is actually a challenge control.
Positive control substance(s):
yes
Remarks:
2-Mercaptobenzothiazole (MBT): intradermal induction: 3%, epicutaneous induction: 25%, challenge: 0.5%; no rechallenge was done
Positive control results:
The positive control substance (0.4% 2-Mercaptobenzothiazole in peanut oil) induced positive reactions in 10/10 animals (100%), thus meeting the reliability criteria.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
5%
No. with + reactions:
9
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
5%
No. with + reactions:
18
Total no. in group:
20
Remarks on result:
positive indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
3%
No. with + reactions:
10
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
5%
No. with + reactions:
7
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
5%
No. with + reactions:
7
Total no. in group:
20
Remarks on result:
positive indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
3%
No. with + reactions:
10
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
5%
No. with + reactions:
5
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
5%
No. with + reactions:
4
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Reading:
rechallenge
Hours after challenge:
48
Group:
negative control
Dose level:
5%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
5%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation

In the test group and the irritation control animals, the 3 intradermal injections of the intradermal induction produced slight to moderate redness around the injection sites at either 1 and 24 h after injection. The topical application of 100% of the test substance for 24 h under occlusive conditions leads to very slight to well-defined erythema in 18/20 animals and severe erythema to slight eschar formation in one animal at the 1 and 24 h observations. Moderate to severe erythema formation was observed in one animal after 24 h. At the 1 h reading, very slight to slight edema were noted in 12/20 animals. At the 24 h reading, very slight to moderate edema were observed in 19/20 animals.

The topical application of peanut oil produced results similar to the treated animals. In all 10 irritation control animals, very slight to severe erythema and very slight to slight edema were noted at the 1 and 24 h observation time points.

The topical challenge dose of 50% test substance in peanut oil leads to very slight erythema in 11/20 animals and to well-defined erythema in 7/20 animals at the 24 h evaluations in test group animals. At the 48 h reading, 6/20 animals had very slight erythema, one animal had well-defined erythema and 13/20 animals were free of erythema. Very slight edema were observed in 4/20 treated animals at the 24 h observation and in one animal at the 48 h observation. In the irritation control group, the topical application of 50% test substance in peanut oil produced very slight erythema in 4/10 animals and well-defined erythema in 5/10 animals at the 24 h reading. At the 48 h observation, 6/10 animals had very slight erythema and one animal had well-defined erythema. Edema was not observed in any irritation control animal at the 24 or 48 h reading.

Since the severity of the erythema was similar between the treated group and the irritation control group and the incidence of erythema was higher in the irritation control group, the response was considered an irritation response and not a sensitization response. An examination of the individual animals' responses showed that the majority of the irritation scores decreased from the 24 h evaluation to the 48 h evaluation, which also is indicative of an irritation and not a sensitization response. However, since there was some irritation from the challenge application, it was decided to rechallenge at a lower concentration to confirm that the test material possessed no sensitization potential.

The rechallenge was performed with 10% test substance in peanut oil and produced very slight erythema in 4/20 animals at the 24 h observation. All animals were free of erythema at the 48 h evaluation. Edema was not observed in any treated animals at the 24 or 48 h observations.

In the irritation control group, topical application of 10% test substance in peanut oil leads to very slight erythema in 4/10 animals and well-defined erythema in one animal at the 24 h observation. All animals were free of erythema at the 48 h evaluation. Edema were not observed in any irritation

control animal at the 24 or 48 h observations.

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
14 Dec 1998-01 February 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
adopted in 1992
Qualifier:
equivalent or similar to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Qualifier:
equivalent or similar to guideline
Guideline:
EPA OPPTS 870.2600 (Skin Sensitisation)
Version / remarks:
draft
GLP compliance:
yes (incl. QA statement)
Remarks:
The Department of Health of the Government of the United Kingdom, UK
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
A non-LLNA test is available that was performed prior to the current data requirements, stipulated in Regulation (EC) No 1907/2006. In accordance with the same Regulation, the data were included to avoid unnecessary testing.
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: David Hall Limited, Burton-on-Trent, Staffordshire, United Kingdom
- Age at study initiation: 8–12 weeks
- Weight at study initiation: 335 – 440 g
- Housing: individually or in pairs in solid-floor polypropylene cages furnished with woodflakes.
- Diet: Guinea Pig FD1, Special Diets Services Limited, Witham, United Kingdom; ad libitum
- Water: ad libitum
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22
- Humidity (%): 44-57
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12

Route:
intradermal and epicutaneous
Vehicle:
other: unchanged and arachis oil BP
Concentration / amount:
intradermal: 25%
epicutaneous: undiluted
Route:
epicutaneous, occlusive
Vehicle:
other: unchanged and arachis oil BP
Concentration / amount:
75% and undiluted
No. of animals per dose:
5 (controls), 10 (test group)
Details on study design:
RANGE FINDING TESTS (selection of concentration):
INDUCTION EXPOSURE (INTRADERMAL)
Four guinea pigs were intradermally injected with 1%, 5%, 10% and 25% w/v in arachis oil BP. The grade of erythema at the injection site was assessed approximately 24, 48 and 72 hours and 7 days after injection according to the Draize scale. The highest concentration that caused only mild to moderate skin irritation, and was well tolerated systemically, was selected for the intradermal induction phase of the main study.
INDUCTION EXPOSURE (TOPICAL)
Two guinea pigs, previously injected with Freund’s Complete Adjuvant (eighteen days earlier), were applied to the clipped flanks under occlusive dressing with undiluted test item and 75%, 50% and 25% v/v of the test item in arachis oil BP for 48 hours. The degree of erythema and oedema was assessed approximately 1, 2 and 48 hours after dressing removal. The highest concentration producing only mild to moderate dermal irritation was selected for the topical induction stage of the main study.
CHALLENGE
Two guinea pigs were treated with undiluted test material and 75%, 50% and 25% v/v in arachis oil BP to the clipped flanks under occlusive conditions for an exposure period of 24 hours. Erythema and oedema score were observed approximately 1, 24, and 48 hours after dressing removal. The highest non-irritant concentration of the test material and one lower concentration were selected for the topical challenge phase of the main study.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous, respectively)
- Exposure period: single injection (intradermal) and 48 hours
- Test groups:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture (v/v) FCA/water
Injection 2: test substance in arachis oil BP
Injection 3: test substance in a 1:1 mixture (v/v) FCA/water

Epicuteneous: test substance in arachis oil BP

- Control group:
Intradermal (3 pairs of injections)
Injection 1: a 1:1 mixture (v/v) FAC/water
Injection 2: arachis oil BP
Injection 3: arachis oil BP at 50% in a 1:1 mixture (v/v) FCA/water
Epicuteneous: arachis oil BP

- Site: shoulder region (intradermal + epicutaneous)
- Frequency of applications: every 7 days
- Duration: Days 0-7
- Concentrations: intradermal 25%, epicutaneous undiluted

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 20
- Exposure period: 24 h
- Test groups: test substance
- Control group: test substance
- Site: right flank (test substance undiluted) and left flank (test substance 75%)
- Concentrations: undiluted and 75%
- Evaluation (hr after challenge): 24 and 48 h after patch removal

Positive control substance(s):
yes
Remarks:
2-Mercaptobenzothiazole (Intradermal induction concentration of 10% in arachis oil, topical induction concentration of 50% in acetone/PEG400; challenge concentration of 50 and 25% in acetone/PEG400)
Positive control results:
The incidence of sensitisation in the historical positive controls was 70-100 % (based on 6 individual experiments).
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
induction: 0%; challenge: 100%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
induction: 0%; challenge: 100%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
induction: 25%; challenge: 75 and 100%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
induction: 25%; challenge: 75 and 100%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
50%
No. with + reactions:
10
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
no analytical purity reported
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
adopted in 1992
Deviations:
yes
Remarks:
analytical purity not reported
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
A non-LLNA test is available that was performed prior to the current data requirements, stipulated in Regulation (EC) No 1907/2006. In accordance with the same Regulation, the data was included to avoid unnecessary testing.
Species:
guinea pig
Strain:
other: Albino Guinea Pigs
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Convance Research Products Inc., Denver, Pennsylvania; USA
- Age at study initiation: approximately 4-7 weeks at dosing (range-finding study; intradermal); approximately 9-12 weeks (rang-finding study; topical); approximately 5-7 weeks at first dose (sensitisation study)
- Weight at study initiation: 376-428 g
- Housing: individually housed in suspended, stainless steel cages with wire mesh bottoms
- Diet: certified Guinea Pig Diet, No. 5026, ad libitum
- Water: automatic watering system (Municipal water supply), ad libitum
- Acclimation period: 8 days (range-finding animals); 14 days (sensitization animals)

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12/12

Route:
intradermal and epicutaneous
Vehicle:
propylene glycol
Concentration / amount:
intradermal: 5%
epicutaneous: 100%
Route:
epicutaneous, occlusive
Vehicle:
propylene glycol
Concentration / amount:
50% and 100%
No. of animals per dose:
5 (controls), 10 (in test groups)
Details on study design:
RANGE FINDING TESTS:
Intradermal:
Two animals were administered intradermal injections (2 injection / animal) of a 5% v/v concentration of test substance in propylene glycol, one on either side of the spinal column. The concentration tested did not produce extensive tissue damage or severe systemic toxicity.

Topical:
4 animals were tested at 4 different concentrations (25, 50, 75% v/v; 100%) per animal (one concentration/site), two on either side of the spinal column. 24 h and 48 h after removal of the patches no signs of erythema and edema were observed for at any of the concentration tested.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous, respectively)
- Exposure period: single injection (intradermal) and
- Test group:
Intradermal (3 pairs of injections)
Injection 1: a 1:1 mixture (v/v) FCA/ water
Injection 2: test substance in propylene glycol
Injection 3: test substance in a 1:1 mixture (v/v) FCA/water
Epicutaneous: test substance in propylene glycol

- Control group:
Intradermal (3 pairs of injections)
Injection 1: a 1:1 mixture (v/v) FCA/ water
Injection 2: propylene glycol
Injection 3: propylene glycol at 50% (v/v) in a 1:1 mixture (v/v) FCA/water
Epicutaneous: propylene glycol

- Site: shoulder region (intradermal + epicutaneous)
- Frequency of applications: every 7 days
- Duration: Days 1-8
- Concentrations: Intradermal 5%, epicutaneous 100%

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 22
- Exposure period: 24 h
- Test groups: test substance
- Control group: test substance
- Site: both flanks (two concentrations were applied for a total of two sites per animal)
- Concentrations: 100% and 50%
- Evaluation (hr after challenge): 24 and 48 h after patch removal



Positive control substance(s):
yes
Remarks:
hexylcinnamic aldehyde (HCA)
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
4
Clinical observations:
one animal was sacrificed on Day 10 at the end of topical induction exposure, due to dosing trauma (humane reasons).
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
4
Clinical observations:
one animal was sacrificed on Day 10 at the end of topical induction exposure, due to dosing trauma (humane reasons)
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
4
Clinical observations:
one animal was sacrificed on Day 10 at the end of topical induction exposure, due to dosing trauma (humane reasons)
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
4
Clinical observations:
one animal was sacrificed on Day 10 at the end of topical induction exposure, due to dosing trauma (humane reasons)
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
100%
No. with + reactions:
5
Total no. in group:
9
Remarks on result:
positive indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
100%
No. with + reactions:
1
Total no. in group:
9
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
no information on purity of the test material; both flanks were exposed during challenge, no reliability check done, no positive control used. Method given in very summarized form
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
no information on purity of the test material; both flanks were exposed during challenge, no reliability check done, no positive control used. Method given in very summarized form.
GLP compliance:
not specified
Type of study:
Buehler test
Justification for non-LLNA method:
A non-LLNA test is available that was performed prior to the current data requirements, stipulated in Regulation (EC) No 1907/2006. In accordance with the same Regulation, the data were included to avoid unnecessary testing.
Species:
guinea pig
Strain:
other: Albino
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 344 - 441 g
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
100%
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
30% and 100%
No. of animals per dose:
20 (10 for the controls)
Details on study design:
RANGE FINDING TESTS: No Data

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 h
- Test groups: Undiluted test sample
- Control group: not stated
- Site: scapular region
- Frequency of applications: 7 d interval
- Duration: 14 d
- Concentrations: undiluted

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: day 28, 14 d after final induction
- Exposure period: 6 h
- Test groups: undiluted (100%) and 30% (w/v in corn oil)
- Control group: undiluted (100%) and 30% (w/v in corn oil)
- Site: undiluted (100%) on left flank and 30% on right flank
- Concentrations: undiluted (100%) and 30% (w/v in corn oil)
- Evaluation (hr after challenge): 24 h and 48 h
Challenge controls:
No
Positive control substance(s):
no
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:
no indication of skin sensitisation
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:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Group:
positive control
Remarks on result:
other: No information on positive control group included in study report.

No information on positive control group included in study report.

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the polyol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly.


For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the polyol esters category.


 


Skin sensitisation potential


There are several reliable animal studies and one repeated insult patch test with humans available for structural analogue source substances investigating the skin sensitisation potential. All studies are accounted for in a Weight-of-Evidence approach.


 


The skin sensitisation potential of Dipentaerythritol hexaesters with fatty acids, C5 and C9iso (CAS No. 647028-25-9) was tested in a guinea pig maximisation test (GPMT) equivalent to OECD Guideline 406 and under GLP conditions (WoE, RA-A, 647028-25-9, 1999b). Suitable doses were investigated by means of a range finding study prior to the main test. 10 male Dunkin-Hartley guinea pigs were treated with the test substance at 25% (diluted in arachis oil BP) for intra- and 100% for epidermal induction on days 1 and 7, respectively. 5 animals served as negative controls. There was no positive control group included in the study but information was given that the incidence of sensitisation in the historical positive controls using 2-Mercaptobenzothiazole was 70-100 %. Epicutaneous challenge was performed on Day 20 with undiluted (right flank) and 75% (diluted in arachis oil BP, left flank) test material under occlusive conditions for 24 h and skin reactions were evaluated 24 h and 48 h after removal of the patches. No animal in either the test or control groups exhibited skin reactions at any reading time point. Therefore, the test substance was considered not to be skin sensitising.


 


The skin sensitisation potential of Pentaerythritol tetraesters of n-decanoic, n-heptanoic, n-octanoic and n-valeric acids (CAS No. 68424-31-7) was evaluated in guinea pigs with a Buehler test for (WoE, RA-A, 68424-31-7, 1991). 20 male albino guinea pigs were treated with the test substance and compared with 10 control animals. Three epidermal inductions were performed with 100 % test substance in weekly intervals for 6 hours under occlusive conditions. 14 days after the last induction treatment, all animals were challenged for 6 hours epicutaneously with 100% (left shorn flank) and 30% (right shorn flank) test substance (diluted in corn oil) under occlusive conditions. Animals were evaluated for skin reactions 24 h and 48 h after challenge. No signs for irritation or sensitisation were observed during induction and challenge of the animals.


 


A guinea pig maximisation test (GPMT) was performed with Fatty acids, C5-9, tetraesters with pentaerythritol (CAS No. 67762-53-2) comparable to the OECD Guideline 406 (Exxon, 1999d). A range-finding study was performed for dose selection. 10 albino guinea pigs were treated with the test substance at 5% for intra- and 100% for epidermal induction on days 1 and 7, respectively. 5 animals served as negative controls. A positive control group was not included in the study but information is given on periodical testing of strain sensitivity using hexylcinnamic aldehyde (HCA). 14 days after the epidermal induction, epidermal challenging was performed with 50 and 100% test material dilution in propylene glycol. 24 h and 48 hours after challenging skin examination revealed no irritation in the test group and control group. Thus, the test material was found to be not sensitising to the skin of guinea pigs, under the conditions of this test.


 


A guinea pig maximisation test was performed with Fatty acids, C8-10 mixed esters with dipenaterythritol, isooctanoic acid, pentaerythritol and tripentaerythritol (CAS No. 189200-42-8) according to a protocol comparable to the OECD Guideline 406 (Exxon, 1995c). A range-finding study was performed for dose selection. 20 female Hartley albino guinea pigs were treated with the test substance at 5% for intra- and 100% for epidermal induction on days 1 and 7, respectively. 10 animals served as negative controls. A positive control group treated with 2-Mercaptobenzothiazole (MBT) (intradermal induction: 3%, epicutaneous induction: 25%, challenge: 0.5%; no rechallenge) was included in the study which showed 100% sensitising reactions. 14 days after the epidermal induction, epidermal challenging was performed with a 50% test material solution in peanut oil. At the first reading, 24 hours after challenge, skin examination revealed irritation reactions in the test group for 18 of 20 animals and in the control group for 9 of 10 animals. 48 hours after challenge, 7 animals in test and control group each showed skin irritation reactions. Since the 50% challenge concentration resulted in skin irritation, a rechallenge was done using 10% test substance. 5 of 10 control animals (50%) and 4 of 20 (20%) test group animals showed skin irritation 24 hours after rechallenge. All skin reactions were completely reversed 48 hours after rechallenge in both groups. Thus, the test material was found to be not sensitising to the skin of guinea pigs, when used as 5% solution for induction and 10% solution for challenge.


 


A repeated insult human patch test (RIPT) was conducted to assess the sensitizing potential of 2,2-bis[[(1-oxoisooctadecyl)oxy]methyl]-1,3-propanediyl bis(isooctadecanoate) (CAS No. 62125-22-8) in 55 human volunteers from the general population (Key, RA-A, 62125-22-8, 1985). Induction was carried out by 10 repeated semiocclusive applications of the unchanged test substance. Patches were placed on the back of volunteers for 24 hours, followed by a 24 hour rest period (48 hours on weekends). The 10 induction patches were applied to the same site. The induction phase was followed by a resting period of 14 days. Challenge patches were applied to the same site on the back and to a naïve site. Skin reactions were assessed 24 and 48 hours after patch removal. None of the human volunteers showed any skin reactions at the end of the study period. Thus, the test material is not considered sensitising to humans.


 


Conclusion on skin sensitisation


Several reliable studies performed with analogue source substances are available investigating the skin sensitisation potential both in animals as well as in humans. All data indicate no potential for skin sensitisation in adequate GPMT, Buehler and human repeated insult patch tests. Thus, no hazard for skin sensitisation is identified for the target substance Octadecanoic acid, 1,1'-[2-[[3-[(1-oxooctadecyl)oxy]-2,2-bis[[(1-oxooctadecyl)oxy]methyl]propoxy]methyl]-2-[[(1-oxooctadecyl)oxy]methyl]-1,3-propanediyl] ester (CAS No. 70967-57-2) either.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

According to Article 13 of Regulation (EC) No. 1907/2006 information on intrinsic properties of substances may be generated by means other than tests, e.g. using information from structurally related substances (grouping or read-across), provided that conditions set out in Annex XI are met. Annex XI states that “substances whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or ‘category’ of substances. This avoids the need to test every substance for every endpoint". Since the read-across concept is applied to the target Octadecanoic acid, 1,1'-[2-[[3-[(1-oxooctadecyl)oxy]-2,2-bis[[(1-oxooctadecyl)oxy]methyl]propoxy]methyl]-2-[[(1-oxooctadecyl)oxy]methyl]-1,3-propanediyl] ester (CAS No. 70967-57-2), data gaps can be filled by interpolation from representative structural analogue source substances to avoid unnecessary animal testing.

The read-across concept is also used to derive the classification of the target substance taking the properties of the source substances into account. Based on the read-across concept, all available data on skin sensitisation in animals and humans do not meet the classification criteria according to Regulation (EC) No. 1272/2008 (CLP) and are therefore conclusive but not sufficient for classification.