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Endpoint summary

Description of key information

Two human patch studies with test item containing 35.8% active ingredient were taken into account for evaluation of sensitisation; both demonstrating that sensitisation is unlikely.

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:

1977

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study was not performed under GLP, but according to state of the art methods of that period . The study was considered relevant, reliable and adequate.

Qualifier:

according to guideline

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:

other: Modified Draize-Shelanski Patch Test

Justification for non-LLNA method:

A Human Insult Patch Test was available before the implementation of in vitro methods

Species:

human

Strain:

not specified

Sex:

male/female

Details on test animals and environmental conditions:

Not applicable

Route:

epicutaneous, occlusive

Vehicle:

petrolatum

Concentration / amount:

Induction 2.5% in petrolatum, Challenge 1% in petrolatum

Route:

epicutaneous, occlusive

Vehicle:

petrolatum

Concentration / amount:

Induction 2.5% in petrolatum, Challenge 1% in petrolatum

No. of animals per dose:

100

Details on study design:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 100
- Exposure period: ten alternate-day 24 hour periods
- Test groups: 100 subjects
- Control group: No
- Site: backs or volar forearms
- Frequency of applications: 10
- Duration: 10 x 24 hours in total
- Concentrations: 2.5% in petrolatum

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

Reading:

1st reading

Group:

positive control

Remarks on result:

other: n.a.; not included in human test design

Reading:

1st reading

Group:

negative control

Remarks on result:

other: n.a.; not included in human test design

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

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 chemical

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: expert judgment

Conclusions:

There were no instances of irritation or sensitisation from this test item on the Draize-Shelanski Patch Test. It is unlikely that this test item would present a danger of irritation or sensitisation in normal, intended use.

Executive summary:

A 15 mm patch 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, 15mm challenge patches of the test item (1% 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, using the 0-4 scale. There were no instances of irritation or sensitisation from this test item on the Draize-Shelanski Patch Test. It is unlikely that this test item would present a danger of irritation or sensitisation in normal, intended use.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Human patch testing

Various human patch studies were available for the registered substance, however quality was different between studies.

- In a key skin sensitisation study a 15 mm patch of the test item containing 35.8% active ingredient (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 (Kligman, 1977). Following a seven-day rest period, 15mm challenge patches of the test item (1% 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, using the 0-4 scale. There were no instances of irritation or sensitisation from this material on the Draize-Shelanski Patch Test. It is unlikely that this test item would present a danger of irritation or sensitisation in normal, intended use.

- In a supporting skin sensitisation study, 100 adult males received 3 successive applications of test item containing 35.8% active ingredient over cantharidin-induced blisters under strict occlusion by aluminum foil and adhesive tape, for 5 days (Kligman 1956). Three weeks after the end of the test, each of the individuals was challenged with a 48 hour patch test to the 35% concentration, showing no sensitisations in this group of 100 men, despite the vigourous conditions of exposure.

- In two disregarded human patch test studies (Hollander, 1943; Hollander, 1956) subjects were tested with 1, 2, 3 and 5% test item containing 35.8% active ingredient versus control materials. Data on study design were missing, and results were ambiguous, therefore they were not further taken into account.

- In conclusion, it is unlikely that this material would present irritation or sensitisation in normal, intended use.

Conclusion

- Based on the repeated negative findings in the human patch studies, potential for skin sensitisation can be excluded.

- Further information supporting the absence of sensitisation potential is also provided in the read across justification for the N2 group, showing that results of the guineapig maximisation test in the group were also negative (justification with data matrix separately attached in Section 13).

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on these results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commission Directive 93/21/EEC) and CLP regulation (EC No. 1272/2008 of 16 December 2008) the test substance does not have to be classified and has no obligatory labelling requirement for sensitisation.