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Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
No data available, ECHA provided study summaries migrated from the SNIF format.
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1995

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Annex V (Maximisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
An LLNA skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study conducted before 24 April 2002 is available.

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
415-650-4
EC Name:
-
Cas Number:
153965-54-9
Molecular formula:
not applicable (multi-constituent)
IUPAC Name:
3-[(2-ethylhexanoyl)oxy]-2,2-bis({[(2-ethylhexanoyl)oxy]methyl})propyl 2-ethylhexanoate; 3-[(2-ethylhexanoyl)oxy]-2,2-bis({[(2-ethylhexanoyl)oxy]methyl})propyl 3,5,5-trimethylhexanoate; 3-[(2-ethylhexanoyl)oxy]-2,2-bis({[(3,5,5-trimethylhexanoyl)oxy]methyl})propyl 3,5,5-trimethylhexanoate; 3-[(2-ethylhexanoyl)oxy]-2-{[(2-ethylhexanoyl)oxy]methyl}-2-{[(3,5,5-trimethylhexanoyl)oxy]methyl}propyl 3,5,5-trimethylhexanoate; 3-[(3,5,5-trimethylhexanoyl)oxy]-2,2-bis({[(3,5,5-trimethylhexanoyl)oxy]methyl})propyl 3,5,5-trimethylhexanoate
Test material form:
other: No data available, ECHA provided study summaries migrated from the SNIF format.
Details on test material:
No data available, ECHA provided study summaries migrated from the SNIF format.

In vivo test system

Test animals

Species:
other: Guinea pig (albino Dunkin-Hartley)

Study design: in vivo (non-LLNA)

Induction
Concentration / amount:
Concentration of test material and vehicle used at induction:
a) Intradermal Induction: 25% (w/v) in arachis oil B.P.

b) Topical Induction: 100% (v/v)

Concentration of test material and vehicle used for each challenge:
a) 100% (v/v)

b) 75% (v/v) in arachis oil B.P.
Challenge
Concentration / amount:
Concentration of test material and vehicle used at induction:
a) Intradermal Induction: 25% (w/v) in arachis oil B.P.

b) Topical Induction: 100% (v/v)

Concentration of test material and vehicle used for each challenge:
a) 100% (v/v)

b) 75% (v/v) in arachis oil B.P.
No. of animals per dose:
Number of animals in test group: 20
Number of animals in negative control group: 10

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
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:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
75 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 75 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
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:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
75 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 75 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
75 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 75 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
75 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 75 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Remarks on result:
other: No data available, ECHA provided study summaries migrated from the SNIF format.

Any other information on results incl. tables

Maximum concentration not causing irritating effects in preliminary test: 75 %

Signs of irritation during induction:
Reactions of grade 1 and 2 were noted in 13 and 1 test group
skin sites respectively, 24 hours after patch removal.

Evidence of sensitisation of each challenge concentration:
None

Other observations:
Bodyweight gains of animals in the test group, between day o
and day 24, were comparable to those in the control group.

Applicant's summary and conclusion

Interpretation of results:
other: Not sensitising.
Remarks:
According Regulation (EC) No. 1272/2008 and its amendments.
Conclusions:
In an adjuvant type guinea pig test method for skin sensitisation according to an EU method and GLP principles, none of the experimental animals showed positive reactions during challenge with RB68.
Executive summary:

RB68 was tested in an adjuvant type guinea pig test method for skin sensitisation according to an EU Method and GLP principles.

Signs of irritation during induction: reactions of grade 1 and 2 were noted in 13 and 1 test group skin sites respectively, 24 hours after patch removal. Control animals showed no reactions. Bodyweight gains of animals in the test group, between day 0 and day 24, were comparable to those in the control group.

None of the experimental animals showed positive reactions during challenge with RB68 hours after patch removal.

RB68 does not have to be classified and has no obligatory labelling requirement for skin sensitisation according to Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (including all amendments).