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Diss Factsheets

Administrative data

Description of key information

This endpoint is fulfilled by a weight of evidence approach detailing a human repeat insult patch test (HRIPT) using the test substance, and a Guinea Pig Maximisation Test (GPMT) using a read-across subtance (2,2 -dimethyl-1,3-propandiol diisononanoate, 27841-07-2 / 27841-07-2; see read across justification in section 13).


The test item is not sensitising to skin as shown on 52 human volunteers.

The skin sensitisation of the target substance was predicted from source substance ( 2,2-Dimethyl-1,3-propandiol diisononanoate. In an OECD 406 test model according to MAGNUSSON and KLIGMAN, the source substance was found to be not skin sensitising. Therefore, on this basis, the target substance is considered to be non-sensitising and is not classified for skin sensitisation according to CLP.

Using a weight of evidence approach, the substance is considered not to be sensitizing to skin.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation, other
Remarks:
Conducted on Humans
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
2005-06-06 to 2005-07-14
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
other: Repeated insult patch test on humans, protocol No. 1.01
Principles of method if other than guideline:
This study has been performed with adherence to the applicable ICH guideline E6 for Good Clinical Practice and requirements provided for in 21 CFR part 50 and 56 and in accordance with standard operating procedures and applicable protocols.
GLP compliance:
no
Type of study:
patch test
Justification for non-LLNA method:
The study was conducted on human subjects, as per annex VII 8.3.1 Column 2: an LLNA test does not need to be conducted because In vivo skin sensitisation studies were carried out or initiated before 11 October 2016, and they meet the requirements set out in Article 13(3), first subparagraph, and Article 13(4).
Species:
human
Sex:
male/female
Details on test animals and environmental conditions:
Fifty-nine qualifed subjects (15 male and 44 female) ranging in age from 16 to 79 years, were selected for this evaluation. Fifty-two subjects completed this study. The remaining subjects discontinued their participation for various reasons, none of which were related to the application of the test material. No controls (postive or challenge) were used.

Only one dose (undiluted) was applied.

The treatment area was defined as the epicutaneous area of the upperback between the scapulae. Approximately 0.2 mL of the test material, or an amount sufficient to cover the contact surface was applied to the 1" x 1" absorbent pad portion of a clear adhesive dressing. This was then applied to the appropropriate treatment site to form a semi-occlusive patch.
Positive control results:
No controls used
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
undiluted
No. with + reactions:
0
Total no. in group:
52
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: undiluted. No with. + reactions: 0.0. Total no. in groups: 52.0. Clinical observations: none.
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
undiluted
No. with + reactions:
0
Total no. in group:
52
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: undiluted. No with. + reactions: 0.0. Total no. in groups: 52.0. Clinical observations: none.

The following Evaluation Key was used during induction and challenge phase:

0 = No visible skin reaction

+ = Barely perceptible or spotty erythema

1 = Mild erythema covering most of the test site

2 = Moderate erythema, possible presence of mild edema

3 = Marked erythema, possible edema

4 = Severe erythema, possible edema, vesiculation, bullae and/or ulceration

During induction phase only one subject showed a moderate erythema, which fully reversed till the second induction. one other subject showed a mild erythema at the first induction reading which revered till the next reading. Thus the substance also did not show any significant skin irritation.

During first and second challenge, no positive reactions were obversed in any of the volunteers (all scores 0).

The study authors concluded that under the conditions of this study, test material Body Oil RP113 -44, did not indicate a potential for dermal iriitation or allergic contact sensitization.

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
2-ethylhexyl 3,5,5-trimethylhexanoate is not sensitising to skin as shown on 52 human volunteers.
Executive summary:

59 volunteers (of which 52 concluded the test) were exposed semi-occlusive to undiluted test material in total 10 times in the induction phase. No significant skin irritation was obeserved throughout this induction phase. Two weeks following the induction phase, volunteers were exposed semi-occlusively again to the undiluted test material (challenge phase) and none of them did show any positive reaction. The study authors concluded that under the conditions of this study, test material Body Oil RP113 -44, did not indicate a potential for dermal iriitation or allergic contact sensitization.

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study conducted using a read across substance
Justification for type of information:
The read across justification is included in Chapter 13.
Reason / purpose for cross-reference:
read-across source
Justification for non-LLNA method:
Other valid animal study preceding OECD LLNA TG was available
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
other: vehicle control
Dose level:
0
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: other: vehicle control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
other: vehicle control
Dose level:
0
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: other: vehicle control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10% test substance in sesame oil
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10% test substance in sesame oil. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
10% test substance in sesame oil
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 10% test substance in sesame oil. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
1st reading
Hours after challenge:
48
Group:
positive control
Dose level:
5% benzocaine in 40% ethanolic 0.9% NaCI solution
No. with + reactions:
20
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 5% benzocaine in 40% ethanolic 0.9% NaCI solution. No with. + reactions: 20.0. Total no. in groups: 20 .0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
72
Group:
positive control
Dose level:
5% benzocaine in 40% ethanolic 0.9% NaCI solution
No. with + reactions:
20
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: positive control. Dose level: 5% benzocaine in 40% ethanolic 0.9% NaCI solution . No with. + reactions: 20.0. Total no. in groups: 20.0 Clinical observations: none.
Interpretation of results:
GHS criteria not met
Conclusions:
Following read across using an OECD 406 test model, the target substance is considered to be non-sensitising predicted from the source 2,2-Dimethyl-1,3-propandiol diisononanoate (27841-07-2 / 27841-07-2) and is not classified for skin sensitisation according to CLP.
Executive summary:

The skin sensitisation of the target substance was predicted from source substance ( 2,2-Dimethyl-1,3-propandiol diisononanoate; 27841-07-2 / 27841-07-2; see read across justification in section 13). In an OECD 406 test model according to MAGNUSSON and KLIGMAN, the source substance was found to be not sensitising to guinea pigs. Therefore, on this basis, the target substance is considered to be non-sensitising and is not classified for skin sensitisation according to CLP.

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

In the human study, 59 volunteers (of which 52 concluded the test) were exposed to the test substance a total 10 times in the induction phase, under semi-occlusive conditions. No significant skin irritation was observed throughout this induction phase. Two weeks following the induction phase, volunteers were exposed semi-occlusively again to the undiluted test material (challenge phase). None showed any positive reaction. The study authors concluded that under the conditions of this study, the test material did not indicate a potential for dermal irritation or allergic contact sensitization.

The skin sensitisation of the target substance was predicted from source substance ( 2,2-Dimethyl-1,3-propandiol diisononanoate; 27841-07-2 / 27841-07-2; see read across justification in section 13) in an OECD 406 test model according to MAGNUSSON and KLIGMAN. On this basis, the target substance is considered to be non-sensitising and is not classified for skin sensitisation according to CLP.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Using an weight of evidence approach the test substance was considered not to be a skin sensitizer based on a human repeat insult patch test and predicted from source substance ( 2,2-Dimethyl-1,3-propandiol diisononanoate (27841-07-2 / 27841-07-2; see read across justification in section 13) in an OECD 406 test study. On this basis, the target substance is not classified for skin sensitisation according to CLP (according to Regulation (EC) No 1272/2008).

Data on respiratory sensitization are not available.

Thus, the substance is not subject to classification as skin sensitizer or respiratory sensitizer according to CLP (according to Regulation (EC) No 1272/2008).