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Additional toxicological data

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Administrative data

Endpoint:
additional toxicological information
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-guideline, GLP-compliant study. Adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Undiluted test sample (0.3 ml) was applied to two regions of clipped rabbit skin for 1 h under occlusion (Hill Top Chamber, held in place with impervious tape). Within 1 h of removal of the chambers, one site was irradiated with UV A light (320-400 nm; 10 J / square cm) while the other site was protected from irradiation (aluminium foil). Regions of negative (untreated) and positive (1% 8-methoxypsoralen) control skin were exposed concurrently to UV A radiation, and all skin reactions recorded using Draize criteria. Results were presented as the photoirritation index (reflecting the mean irritative response for UV-irradiated skin in the presence or absence of test sample).
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: Viscous hydrocarbon liquid
Details on test material:
- Name of test material (as cited in Sponsor documentation): F-136, heavy thermocracked distillate

Results and discussion

Any other information on results incl. tables

Results presented as the photoirritation index = (24 + 72 mean for erythema and oedema after treatment with test substance and UV irradiation) - (24 + 72 mean for erythema and oedema after UV irradiation without treatment with test substance).

Mean photoirritation index = 2.8

Time course for findings:

 

 24 hr

48 hr 

 72 hr

 Erythema, -UV

 0.8

1.2 

1.2 

 Erythema, +UV

 1.4

2.2 

2.8 

 Oedema, -UV

 0.4

0.4

0.4 

 Oedema, +UV

 1.6

2.4

 2.6

Applicant's summary and conclusion

Conclusions:
The sample had a moderate potential to evoke photoirritation.
Executive summary:

In a photoirritation study, 0.3 mL of the test material (F-136, heavy thermocracked distillate; CAS# 64741-81-7) was dermally administered (undiluted) to the clipped dorsal skin of 5 New Zealand White rabbits and covered under occlusive dressing for a period of 1 hour. The animals were subsequently observed for a period of 3 days.

 

The mean photoirritation index was determined to be 2.8.

 

It was concluded that the heavy thermocracked distillate has a moderate potential to evoke photoirritation.