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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
no data
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Justification for type of information:
The study was performed according to a valid guideline without any deviations and was conducted under GLP conditions. Furthermore, the data were submitted by another legal entity, under Directive 67/548/EEC, at least 12 years previously. The registrant has been granted permission to use the information, which has been extracted from the ECHA databases, for REACH registration purposes. No full information related to the experimental result are available but these deficiencies do not affect the quality of the relevant results.

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
2000

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Annex V (Maximisation test).
Deviations:
not specified
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
the in vivo study was available because these data were already submitted by another legal entity, under Directive 67/548/EEC, at least 12 years ago.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
no data
Specific details on test material used for the study:
no data

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: albino Dunkin-Hartley
Sex:
not specified
Details on test animals and environmental conditions:
no data

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
other: intradermal and topical
Vehicle:
arachis oil
Concentration / amount:
Concentralion of test materia! and vehicle used at induclion:
a)lntradennal lnduction: 10% in arachis oil
b)Topical lnduclion: 50% in arachis oil

Concentration of test materia! and vehicle used for each challenge:
a) 50% in arachis oil BP
b) 25% in arachis oil BP
Challengeopen allclose all
Route:
other: no data
Vehicle:
arachis oil
Concentration / amount:
Concentralion of test materia! and vehicle used at induclion:
a)lntradennal lnduction: 10% in arachis oil
b)Topical lnduclion: 50% in arachis oil

Concentration of test materia! and vehicle used for each challenge:
a) 50% in arachis oil BP
b) 25% in arachis oil BP
No. of animals per dose:
Number of animals in test group: 10
Number of animals in negalive contro! group: 5
Details on study design:
no data
Challenge controls:
no data
Positive control substance(s):
not specified

Results and discussion

Positive control results:
no data

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no data
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no data.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no data
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no data.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no data
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no data.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no data
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no data.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no data
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no data.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no data
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no data.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no data
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no data.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no data
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no data.

Any other information on results incl. tables

Maximum concentration not causing irritating effects in preliminary test: 50 %.

Signs of irritation during induction:

Intradermal Induction:

Discrete or patchy to moderate and confluent erythema was noted at the intradermal induction sites of all test group animals at the 24-hour observation and in nine test group animals at the 48 hour observation.

Discrete or patchy erythema was noted at the intradermal induction sites of three control group animals at the 24-hour observation and in two control group animals at the 48-hour observation.

Topical Induction:

Discrete or patchy erythema was noted at the induction sites of these -test group animals at the 1-hour observation. No skin reactions were noted at the induction sites of test group animals at the 24-hour observation.

No signs of erythema or oedema were noted at the treatment sites of control group animals at the l and 24-hour observation.

Evidence of sensitisation of each challenge concentration: Number of animals showing evidence of sensitization at each

challenge concentration: 0/10 (with 25 and 50% concentrations).

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the test conditions, the test material was judged to be not sensitising to the skin.
Executive summary:

The skin sensitisation potential of the test material was investigated in a study which was conducted under GLP conditions following the guinea pig Maximisation test method.

Under the test conditions, the test material was judged to be not sensitising to the skin.