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Additional toxicological data

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Endpoint:
additional toxicological information
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-guideline, GLP-compliant study. Adequate for assessment.
Justification for type of information:
Read across justification included in Section 13
Cross-reference
Reason / purpose for cross-reference:
read-across: supporting information
Reference
Endpoint:
additional toxicological information
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-guideline, GLP-compliant study. Adequate for assessment.
Justification for type of information:
Read across justification included in Section 13
Reason / purpose for cross-reference:
read-across source
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

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 = 4.5

Time course for findings:

 24 hr

48 hr 

 72 hr

 Erythema, -UV

 0

0.8 

0.8 

 Erythema, +UV

 2.0

2.6 

3.6 

 Oedema, -UV

 0

0.2

0.2 

 Oedema, +UV

 1.8

2.8

2.6

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

In a photoirritation study, 0.3 mL of the test material (F-115-01, FCCU clarified oil; CAS# 64741-62-4) 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 4.5.

 

It was concluded that FCCU clarified oils have a moderate potential to evoke photoirritation.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

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

Constituent 1
Reference substance name:
64741-62-4
Cas Number:
64741-62-4
IUPAC Name:
64741-62-4
Test material form:
other: Viscous hydrocarbon liquid
Details on test material:
- Name of test material (as cited in Sponsor documentation): F-115-01, FCCU clarified oil

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 = 4.5

Time course for findings:

 24 hr

48 hr 

 72 hr

 Erythema, -UV

 0

0.8 

0.8 

 Erythema, +UV

 2.0

2.6 

3.6 

 Oedema, -UV

 0

0.2

0.2 

 Oedema, +UV

 1.8

2.8

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-115-01, FCCU clarified oil; CAS# 64741-62-4) 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 4.5.

 

It was concluded that FCCU clarified oils have a moderate potential to evoke photoirritation.