Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Diss Factsheets

Administrative data

Endpoint:
skin sensitisation
Adequacy of study:
other information

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Commission Directive 92/69/EEC, Method B6 (Magnusson and Kligman maximisation test).
GLP compliance:
yes

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: 5% (w/v) in arachis oil BP.




b) Topical Induction: 50% (w/v) in arachis oil BP.

Concentration of test material and vehicle used for each challenge:
10% and 5% (w/w) in arachis oil BP.
Challenge
Concentration / amount:
Concentration of test material and vehicle used at induction:
a) Intradermal Induction: 5% (w/v) in arachis oil BP.




b) Topical Induction: 50% (w/v) in arachis oil BP.

Concentration of test material and vehicle used for each challenge:
10% and 5% (w/w) in arachis oil BP.
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:
5 %
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: 5 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10 %
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: 10 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
5 %
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: 5 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10 %
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: 10 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
5 %
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: 5 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
10 %
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: 10 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
5 %
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: 5 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
10 %
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: 10 %. No with. + reactions: 0.0. Total no. in groups: 10.0.

Any other information on results incl. tables

Maximum concentration not causing irritating effects in preliminary test: 10 %

Signs of irritation during induction:
Moderate and diffuse redness or intense redness and swelling
was noted at the intradermal induction sites of all test

group animals at the 24 and 48-hour observations.


Scattered mild redness was noted at the intradermal
induction sites of eight control animals at the 24-hour
observation and in five control group animals at the 48-hour
observation.


Moderate and diffuse redness was noted at the induction
sites of all test group animals at the 1-hour observation
and persisted at the induction sites of three test group
animals at th 24-hour observation. Scattered mild redness
was noted at the induction sites of seventeen test group
animals at the 24-hour observations.


Slight oedema was noted at the induction sites of fourteen
test group animals at the 1-hour observation and at the
induction sites of three test group animals at the 24-hour
observation. Residual test material was noted at the
induction sites of all test group animals at the 1-hour
observation and persisted at the induction sites of seven
test group animals at the 24-hour observation.


No skin reactions were noted at the treatment sites of the
control group aniimals at th 1 and 24-hour observations.

Evidence of sensitisation of each challenge concentration:
Number of animals showing evidence of sensitisation at each
challenge concentration: 0/20.

Other observations:
One control group animal was found dead on Day 20. The cause
of death was not determined but the absence of this animal
was considered not to affect the purpose or integrity of the
study.

Applicant's summary and conclusion

Interpretation of results:
other: not classified