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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:
disregarded due to major methodological deficiencies
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: secondary references

Data source

Materials and methods

Type of study:
other: human maximization study
Justification for non-LLNA method:
before adoption of LLNA method

In vivo test system

Test animals

Species:
other: human

Results and discussion

Any other information on results incl. tables

Sensitization

Data lacking

No valid studies are available. The available study gets a K4 since no original references are available only secondary references.The lack of individual scores and the use of a non-standard technique preclude classification on the basis of EU or GHS criteria

 

Classification and Labeling

Since only secondary references are available the data is not sufficient for C&L purposes.

A maximization test was carried out on 25 volunteers. The material (RIFM no. 76-331) was tested at a concentration of 4% in petrolatum and produced no sensitization reactions.

 

 

 

 

 

 

In a human maximization study involving 25 subjects, there were no positive reactions to (2760 µg/cm2) in petrolatum. The patch site was pre-treated for 24-h with 2.5% aqueous sodium lauryl sulfate under occlusion. Test material was then applied under occlusion to the same site on the volar forearm or back for a total of five alternate-day 48 h periods.

Following a 10-day rest period, fresh challenge sites were pretreated for 1 h with 5–10% aqueous sodium lauryl sulfate solution and challenge patches were then applied to fresh sites under occlusion for 48 h. Challenge sites were evaluated immediately after patch removal and at 24 h

Kligman. A. M. (1966). The identification of contact allergens by human assay. III. The maximization test. A procedure for screening and rating contact sensitizers. J. Invest. Derm..47, 393; Kligman. A. M. (1977). Report to RIFM. 6 June;

Kligman. A. M. & Epstein. W. (1975). Updating the maximization test for identifying contact allergens. Contact

Dermatitis1, 231. Cited in:Food and Chemical Toxicology. Vol. 20, Pg. 675, 1982

 

RIFM (Research Institute for Fragrance Materials, Inc.), 1977. Report on Human Maximization Studies. RIFM Report No. 1702, June 06. RIFM, Woodcliff Lake, NJ, USA. Cited in:Scognamiglio J,Jones L,Letizia CS,Api AM.Fragrance material review on 2-phenyl-2-propanol.Food Chem Toxicol.2012 Sep;50 Suppl 2:S130-3.

Repeated Insult Patch Test: Fifty-five human subjects received 24-hr exposures to test patches three times weekly for 3 weeks and a challenge patch in the sixth week. There was little or no primary irritation. There was, however, a definite indication of skin sensitization in 7 of the 35 subjects, and more or less equivocal evidence of sensitization in 10 other subjects.

HERCULES INC; Technical Data Bulletin for Di-Cup (Dicumyl Peroxide) Including Toxicity Data for A-Methylstyrene, One of its Decomposition Products; 00/00/00; EPA No. 86-870001667; Fiche No. OTS0515743

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
No valid studies are available. The available study gets a K4 since no original references are available only secondary references.The lack of individual scores and the use of a non-standard technique preclude classification on the basis of EU or GHS criteria
Executive summary:

No valid studies are available. The available study gets a K4 since no original references are available only secondary references.The lack of individual scores and the use of a non-standard technique preclude classification on the basis of EU or GHS criteria