Registration Dossier
Registration Dossier
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EC number: 701-293-4 | CAS number: -
Additional toxicological data
Administrative data
- 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
- 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.
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 |
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- 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
- 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
Constituent 1
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.
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