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Description of key information

A modified Draize-Shelanski Repeat Insult Patch Tests was carried out to test for sensitization with a batch containing > 90% active ingredient.There was no irritation or sensitization from this test item on the Draize-Shelanski Test. It is unlikely that this test item would present a danger of irritation or sensitization in normal, intended use.

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:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
The study was not performed under GLP, but the study was conducted according to standards of that time, therefore the study is considered to be adequate, reliable and relevant.
Justification for type of information:
The Human insult patch test was historically present for the substance and was considered to be most relevant and valid.
Qualifier:
according to
Guideline:
other: Modified Draize-Shelanski Repeat Insult Patch Test
Deviations:
no
Principles of method if other than guideline:
Human predictive skin sensitisation tests have been in use the last 50 years. They have been used more widely in the United States than in Europe. Sensitisation potential has been investigated, and the development of animal sensitisation tests was partly based on comparison to human tests performed with the same chemicals. Further, human testing has the advantage that extrapolation of the test results from one species to another is avoided. There are a number of different human sensitisation tests available.(http://ec.europa.eu/health/scientific_committees/consumer_safety/opinions/sccnfp_opinions_97_04/sccp_out102_en.htm)
GLP compliance:
no
Type of study:
patch test
Justification for non-LLNA method:
The Human insult patch test was historically present for the substance and was considered to be most relevant and valid.
Specific details on test material used for the study:
The Human insult patch test was historically present for the substance and was considered to be most relevant and valid.
Species:
human
Strain:
other: not applicable
Sex:
male/female
Details on test animals and environmental conditions:
Not applicable
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
2.5% in petrolatum( Induction)
1% in petrolatum (Challenge)
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
2.5% in petrolatum( Induction)
1% in petrolatum (Challenge)
No. of animals per dose:
100 humans
Details on study design:
RANGE FINDING TESTS: Not provided

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures:
- Exposure period: 10 alternate-day 24 hour periods
- Test groups: 1 group of 100 humans
- Control group: No
- Site: on the backs or volar forearms
- Concentrations:2.5%

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 1day
- Exposure period: 24 hours
- Test groups: 1 group of 100 humans
- Control group: No
- Site: fresh sites on the backs or volar forearms
- Concentrations: 1% in petrolatum
- Evaluation (hr after challenge): after 24 and 48 hours

Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
1% in petrolatum
No. with + reactions:
0
Total no. in group:
100
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1% in petrolatum. No with. + reactions: 0.0. Total no. in groups: 100.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
1% in petrolatum
No. with + reactions:
0
Total no. in group:
100
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1% in petrolatum. No with. + reactions: 0.0. Total no. in groups: 100.0.
Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
There were no instances of irritation or sensitization from this test item on the Draize-Shelanski Test.
It is unlikely that this test item would present a danger of irritation or sensitization in normal, intended use.
Executive summary:

Approximately 300 mg of the Butanedioic acid, sulfo-, 1,4 -dicyclohexyl ester, sodium salt, >90% pure (2.5% in petrolatum) was applied to patch sites on the backs or volar forearms of 100 subjects for ten alternate-day 24 hour periods under occlusion. Following a seven-day rest period, challenge patches of the test item (1.0% in petrolatum) were applied in the same manner to fresh sites on the backs or volar forearms of all 100 subjects for 24 hours. Challenge sites were read on removal of the patch and 24 hours thereafter.There were no instances of irritation or sensitization from this test item on the Draize-Shelanski Test. It is unlikely that this test item would present a danger of irritation or sensitization in normal, intended use.

Endpoint:
skin sensitisation: in vitro
Data waiving:
other justification
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

A modified Draize-Shelanski Repeat Insult Patch Test was carried out to test for sensitisation with a batch containing > 90% active ingredient (Kligman, 1976). The study design was as follows: approximately 33 mg of the test item (2.5% in petrolatum) was applied to patch sites on the backs or volar forearms of 100 subjects for ten alternate-day 24 hour periods under occlusion. Following a seven-day rest period, challenge patches of the test item (1.0% in petrolatum) were applied in the same manner to fresh sites on the backs or volar forearms of all 100 subjects for 24 hours. Challenge sites were read on removal of the patch and 24 hours thereafter. There were no instances of irritation or sensitisation from this material on the Draize-Shelanski Test. It is unlikely that this test item would present a danger of irritation or sensitisation in normal, intended use.

Further information supporting the absence of sensitisation potential is provided in the read across justification for the Diester category, showing that all substances in the group were negative for human patch testing on the human arm skin (justification with data matrix separately attached in Section 13).

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

As there was no indication for sensitisation from the human patch test with current test item and category analogues, classification for skin sensitisation is not needed according to the EC Directive (No.93/21/EEC) and CLP (No. 1272/2008 of 16 December 2008).