Registration Dossier
Registration Dossier
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EC number: 941-364-9 | CAS number: -
Specific investigations: other studies
Administrative data
- Endpoint:
- phototoxicity
- 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: This study is classified as reliable with restrictions because it is an acceptable, well-documented study report.
- Justification for type of information:
- Read across justification included in Section 13
Cross-reference
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- phototoxicity
- 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: This study is classified as reliable with restrictions because it is an acceptable, well-documented study report.
- Justification for type of information:
- Read across justification included in Section 13
- Reason / purpose for cross-reference:
- read-across: supporting information
- 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
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- female
- Route of administration:
- dermal
- Vehicle:
- unchanged (no vehicle)
- 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.
- 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.
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 |
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 1 990
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 substance name:
- Petroleum gas oil fraction, co-processed with renewable hydrocarbons of plant and/or animal origin
- EC Number:
- 941-364-9
- Molecular formula:
- Not applicable to UVCB substance
- IUPAC Name:
- Petroleum gas oil fraction, co-processed with renewable hydrocarbons of plant and/or animal origin
- Test material form:
- liquid
- Details on test material:
- EC 941-364-9
Reference substance for target in read-across analogue approach
Constituent 1
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.
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