Registration Dossier

Administrative data

Endpoint:
phototoxicity
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable with restrictions because it is an acceptable, well-documented study report.

Data source

Reference
Reference Type:
secondary source
Title:
Unnamed
Year:
1990

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Undiluted test material was dosed at 0.3 mL/site, two test sites per animal. Single one hour exposure to test article, 10J/cm2 UV A exposure (5.6 hours). Observations were made at 30 minutes and 24, 48, and 72 hours post UV A exposure.
GLP compliance:
yes
Type of method:
in vivo
Endpoint addressed:
skin irritation / corrosion

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: low viscosity liquid hydrocarbon

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
female

Administration / exposure

Route of administration:
dermal
Vehicle:
unchanged (no vehicle)

Results and discussion

Details on results:
The mean scores (erythema plus oedema) for intact skin are detailed in the table of the results section. Based on the 24 and 72 hour scores, the irritation index for the test material is 5.4 and 2.1 for exposed and unexposed skin. The photo irritation index is 3.3.

Any other information on results incl. tables

Mean scores (erythema plus oedema) for intact skin sites. Score range from 0 -8, 0=no reaction, 8=severe

Exposed to UV A

24 hour

72 hour

1% Methoxypsoralen

6.6

5.8

Test material F-188

5.4

5.4

Not exposed to UV A

 

 

1% Methoxypsoralen

0.0

0.0

Test material F-188

2.0

2.2

Applicant's summary and conclusion

Conclusions:
Based on the 24 and 72 hour scores, the irritation index for thes test material is 5.4 and 2.1 for exposed and unexposed skin. The photoirritation index is 3.3. Based on the parameters of this study, the test article is a moderate photoirritant to the skin of albino rabbits.
Executive summary:

In a photoirritation study, 5 female New Zealand White rabbits were dosed with undiluted test material (Naval distillate) at 0.3 mL/site, two test sites per animal. Single one hour exposure to test article and 10J/cm2 UV A exposure (5.6 hours). Observations were made at 30 minutes and 24, 48, and 72 housr post UV A exposure.

Based on the 24 and 72 hour scores, the irritation index for thes test material is 5.4 and 2.1 for exposed and unexposed skin. The photoirritation index is 3.3. Based on the parameters of this study, the test article is a moderate photoirritant to the skin of albino rabbits.

This study received a Klimisch score of 2 and is classified as reliable with restrictions because it is an acceptable, well-documented study report.