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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:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Only summary data provided with limited information on methods and results.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
Final report on the safety assessment of propylene carbonate
Author:
Beyer KH Jr., Bergfeld WF, Berndt, WO, et al.
Year:
1987
Bibliographic source:
Journal of the American College of Toxicology Vol 6, (1)

Materials and methods

Principles of method if other than guideline:
Schwartz and Peck ( 1944. Pub Health Rep 59:, 546-557)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
- Name of test material (as cited in study report): Eye care products containing between 1.51 and 1.98% Propylene carbonate

In vivo test system

Test animals

Species:
human
Sex:
not specified

Study design: in vivo (non-LLNA)

Induction
Route:
other: closed and open patch
Vehicle:
unchanged (no vehicle)
Concentration / amount:
Three eye area products containing between 1.51% and 1.98% test substance was tested.
Challenge
Route:
other: closed and open patch
Vehicle:
unchanged (no vehicle)
Concentration / amount:
Three eye area products containing between 1.51% and 1.98% test substance was tested.
No. of animals per dose:
304 subjects total
Details on study design:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: single
- Exposure period: 48 hours

B. CHALLENGE EXPOSURE
- No. of exposures: single
- Exposure period: 48 hours

OTHER : 10-14 day nontreatment period following induction and the start of the challenge exposure.
The closed patch sites were irradiated with ultraviolet (UV) light following both induction and challenge gradings. The light source consisted of a Spectronics B-100 broad spectrum lamp, which included in its spectrum a wavelength of 365 nm. The lamp was held 12 inches from the skin for 1 minute.

Results and discussion

In vivo (non-LLNA)

Results
Reading:
other: all
Hours after challenge:
48
Group:
test group
Dose level:
between 1.51% and 1.98%
No. with + reactions:
0
Total no. in group:
304
Remarks on result:
other:
Remarks:
2 subjects had weak, nonvesicular reactions to the closed patch. Four developed skin reactions to the UV light. No reactions to the open challenge patches were observed.

Any other information on results incl. tables

Induction results: Of the 304 subjects, 9 had weak (nonvesicular) reactions and 1 had an extreme (bullous or ulcerative) reaction to the closed patch. No reactions were observed as a result of the open induction patch or as a result of UV exposure.

Challenge results: Of the 304 subjects, 2 had weak, nonvesicular reactions to the closed patch, whereas 4 developed skin reactions to the UV light; no reactions to the open challenge patches were observed.

It was not ascertained whether the few positive reactions to the exaggerated closed patch conditions and to the UV light were due to the test substance or other ingredients in the product.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The three eye care products were considered to be nonirritating, nonsensitizing, and nonphtotosensitizing under conditions of the test.