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Diss Factsheets

Administrative data

Description of key information

There is no data available about the sensitisation potential Dipentaerythritol hexaesters of 3,5,5-trimethylhexanoic and n-heptanoic acids (CAS 1379424 -11 -9). In order to fulfil the standard information requirements set out in Annex VIII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from a structurally related substance was conducted.

The substance EC 444 -000-2 consists of dipentaerythritol hexaesters with fatty acids 3,5,5 -trimethylhexanoic acid and n-pentanoic acid and it is considered to be similar to the target substance, on the basis of the structural and similar properties and/or activties.

The available skin sensitisation study for the source substance (GLP study, OECD 406 method, result "non-sensitising") is used to predict the same behabiour for the target substance Dipentaerythritol hexaesters of 3,5,5 -trimethylhexanoic and n-heptanoic acids (CAS 1379424 -11 -9).

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:
key study
Study period:
14 Dec 1998 - 01 February 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
adopted in 1992
Deviations:
yes
Remarks:
no analytical purity reported
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
yes
Remarks:
no analytical purity reported
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2600 (Skin Sensitisation)
Version / remarks:
draft
Deviations:
yes
Remarks:
no analytical purity reported
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:
The validity of the LLNA was endorsed by ECVAM (European Centre for the Validation of Alternative Methods) on 21 March 2000.
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, UK
- Age at study initiation: 8–12 weeks
- Weight at study initiation: 335–440 g
- Housing: animals were housed individually or in pairs in solid-floor polypropylene cages furnished with woodflakes.
- Diet: Guinea Pig FD1 (Special Diets Services Limited, Witham, UK), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

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

Route:
intradermal and epicutaneous
Vehicle:
arachis oil
Concentration / amount:
Induction: intradermal 25%; epicutaneous 100%
Challenge: 75 and 100%
Route:
epicutaneous, occlusive
Vehicle:
arachis oil
Concentration / amount:
Induction: intradermal 25%; epicutaneous 100%
Challenge: 75 and 100%
No. of animals per dose:
5 (controls), 10 (in test groups)
Details on study design:
RANGE FINDING TESTS
INDUCTION EXPOSURE (INTRADERMAL)
Four guinea pigs were intradermally injected with 0.1 mL of 1, 5, 10 and 25% (w/v) of the test material in arachis oil BP. The grade of erythema at the injection site was assessed approximately 24, 48 and 72 h 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 Freud’s Complete Adjuvant (eighteen days earlier), were treated with the undiluted test item and 75, 50 and 25% (v/v) of the test item in arachis oil BP for 48 h (clipped flanks; occlusive dressing). The degree of erythema and edema was assessed approximately 1, 2 and 48 h 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 applied to the clipped flanks under occlusive conditions for an exposure period of 24 h. The highest non-irritant concentration of the test material and one lower concentration were selected for the topical challenge phase of the main study. The treated skin was evaluated for erythema and edema scores were observed approximately 1, 24, and 48 h after dressing removal.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous, respectively)
- Exposure period: single injection (intradermal) and 48 h (epicutaneous)
- 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

Epicutaneous: test substance in arachis oil BP

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

- Site: shoulder region (intradermal + epicutaneous)
- Frequency of applications: every 7 days
- Duration: Days 0-7
- Concentrations: intradermal 25%, epicutaneous 100%

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 100%) and left flank (test substance 75%)
- Concentrations: 75 and 100%
- 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:
At least two tests per year are performed in the laboratory. 100% of the animals in the test group (10 males) showed incidence of sensitisation.
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:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: induction: 0%; challenge: 100%. No with. + reactions: 0.0. Total no. in groups: 5.0.
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:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: induction: 25%; challenge: 75 and 100%. No with. + reactions: 0.0. Total no. in groups: 10.0.
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:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: induction: 0%; challenge: 100%. No with. + reactions: 0.0. Total no. in groups: 5.0.
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:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: induction: 25%; challenge: 75 and 100%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Group:
positive control
Dose level:
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
No. with + reactions:
10
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation
Interpretation of results:
not sensitising
Conclusions:
CLP: not classified
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
There are no data available on the skin sensitisation potential of the substance Dipentaerythritol hexaesters of 3,5,5-trimethylhexanoic and n-heptanoic acids (CAS 1379424 -11 -9). In order to fulfil the standard information requirements set out in Annex VII, 8.3, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from a structurally related substance was conducted.
In accordance with Article 13 (1) of Regulation (EC) No 1907/2006, "information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI are met. In particular for human toxicity, information shall be generated whenever possible by means other than vertebrate animal tests", which includes the use of information from structurally related substances (grouping or read-across).
Having regard to the general rules for grouping of substances and read-across approach laid down in Annex XI, Item 1.5, of Regulation (EC) No 1907/2006, whereby toxicological properties may be predicted from data for the reference substance(s) on the basis of structural similarity, the substance Dipentaerythritol with fatty acids C5 and C9 iso (CAS 647028-25-9) is selected as reference substance for assessment of toxicological endpoints, for which information gaps are identified. A detailed analogue approach justification is provided in the technical dossier (see IUCLID Section 13).
Reason / purpose for cross-reference:
read-across source
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
Induction: 0% ; challenge: 100%
No. with + reactions:
0
Total no. in group:
0
Remarks on result:
no indication of skin sensitisation
Key result
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
Key result
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
Key result
Reading:
1st reading
Group:
positive control
Dose level:
Intradermal induction: 10%; topical induction: 50%; challenge: 50 and 25%
No. with + reactions:
10
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
induction: 25% ; challenge: 100%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
GHS criteria not met
Conclusions:
The source substance Dipentaerythritol wiht fatty acids C5 and C9iso resulted non sensitising in a GLP GPMT sensitisation study (OECD 406).
Based on the results from the structurally related source substance, it can be concluded that the target substance Dipentaerythritol hexaesters of 3,5,5-trimethylhexanoic and n-heptanoic acids will not exhibit skin irritation /corrosion effects.
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 read-across from a structurally similar substance, the available data on skin/ sensitisation potential do not meet the classification criteria according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.