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Description of key information

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.

According to ECHA Guideline (Chapter R.7a: Endpoint specific guidance Version 5.0. 2016), registrants need to collect all available relevant information on their substance. It is advised to start by looking at all experimental data for skin sensitisation that may already be available from REACH registration dossiers or from other sources. The data collected are related to the dossier submitted under Directive 67/548/CEE and it is older than 12 years.

REACH Regulation establishes that the Murine Local Lymph Node Assay (LLNA) is the first-choice method for in vivo testing. Only in exceptional circumstances should another test be used.

In case an experimental results suggests that a significant sensitisation (Cat . 1A) cannot be excluded with sufficient confidence based on in vitro/in chemico testing, additional information (in silico/in vitro/in chemico) would need to be generated to strengthen the weight of evidence. If still no reliable conclusion can be reached, as a last resort in vivo testing (LLNA) would need to be perfomed.

In this case, an in vivo study is available and the Author concluded that under the test conditions, the test material was judged to be not sensitising to the skin.

This information was judged as essential to fullfil the information request of the REACH Regulation.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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.
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.
Specific details on test material used for the study:
no data
Species:
guinea pig
Strain:
other: albino Dunkin-Hartley
Sex:
not specified
Details on test animals and environmental conditions:
no data
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
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
Positive control results:
no data
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.

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).

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.

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

no data

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification