Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
