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Diss Factsheets

Administrative data

Description of key information

Skin sensitisation (EU Method): not sensitising

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:
No data available, ECHA provided study summaries migrated from the SNIF format.
Reliability:
2 (reliable with restrictions)
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.
Species:
other: Guinea pig (albino Dunkin-Hartley)
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.
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
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.

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.

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).

Endpoint:
skin sensitisation: in vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

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.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the study results, 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).