Registration Dossier
Registration Dossier
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EC number: 224-506-8 | CAS number: 4390-04-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- From 30th of April to 3rd of May 1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Method similar as OECD guideline N°404 in compliance with GLP. Six rabbits were treated. Substance identification: code name with commercial substance name. Substance analytical certificate not available in the report
- Justification for type of information:
- The justification for read across is provided as an attachment in IUCLID Section 13.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- From 30th of April to 3rd of May 1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Method similar as OECD guideline N°404 in compliance with GLP. Six rabbits were treated. Substance identification: code name with commercial substance name. Substance analytical certificate not available in the report
- Justification for type of information:
- The justification for read across is provided as an attachment in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- No animal death prior to study termination.
Topical application of MRD-90-903 elicited no responses in any animal. - Other effects:
- No additional data.
- Interpretation of results:
- other: Not irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, MRD-90-903 is not classified as skin irritant according to the criteria of Annex VI of the Directive 67/548/EEC and the CLP Regulation 1272/2008.
- Executive summary:
This data is being read across from the source study that tested Hydrocarbons, C16-C20, n-alkanes, isoalkanes, cyclics, <2% aromatics based on analogue read across.
In a primary dermal irritation study conducted as similar to OECD guideline N°404 in compliance with GLP, six young adult female New Zealand White rabbits were dermally exposed to 0.5 mL of MRD-90-903. Test sites were covered with a semi-occlusive dressing for 4 hours. The skin reactions were assessed at 45 minutes, 24, 48 and 72 hours after removal of the dressing. The mean score was calculated across 3 scoring times for all animals at 24, 48 and 72 hours after patch removal.
The mean scores over 24, 48 and 72 hours were 0.0 for erythema and for oedema.
Based upon the directive 67 /548/EEC and the CLP Regulation 1272/2008, MRD-90-903 is not considered as irritating to the rabbit skin.
Table 7.3.1/1:Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test
Score at time point / Reversibility |
Erythema |
Edema |
Max. score: 4 |
Max. score: 4 |
|
24 h |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
48 h |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
72 h |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
Average 24h, 48h, 72h |
0.0 |
0.0 |
Reversibility* |
- |
- |
Average time (unit) for reversion |
- |
- |
*Reversibility: c. = completely reversible;= not completely reversible; n. = not reversible
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- One rabbit was sacrificed by cardiac puncture. The authors considered this deviation is not pertinent.
- Principles of method if other than guideline:
- Guideline principles
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Hydrocarbons, C16-C20, n-alkanes, isoalkanes, cyclics, <2% aromatics
- EC Number:
- 919-029-3
- Molecular formula:
- Combination of mainly CnH2n+2 and CnH2n structures, comprised mainly within a carbon number range from C16 to C20
- IUPAC Name:
- Hydrocarbons, C16-C20, n-alkanes, isoalkanes, cyclics, <2% aromatics
- Reference substance name:
- Exxsol D140
- IUPAC Name:
- Exxsol D140
- Reference substance name:
- MRD-90-903
- IUPAC Name:
- MRD-90-903
- Details on test material:
- - Name of test material (as cited in study report): MRD-90-903
- Substance type: petroleum product, UVCB
- Physical state: colorless liquid
- Analytical purity: 100% Commercial product
- Lot/batch No.: I
- Storage condition of test material: room temperature
- Other: pH=6
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hazleton Research Products, Denver, PA
- Age at study initiation: approximately 12 weeks
- Weight at study initiation: 1.85 to 2.29 kg
- Housing: individual
- Diet (e.g. ad libitum): Agway Certified Diet R.C.A. Rabbit, restricted feeding regimen
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): from 65 to 70°F
- Humidity (%): maintained range of 40 to 60% relative humidity
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): approximately 12 hours light and 12 hours dark
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: electric clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL dose
- Concentration (if solution): substance tested undiluted (as supplied) - Duration of treatment / exposure:
- Approximately 4 hours of exposure.
- Observation period:
- Dermal responses were evaluated approximately 45 minutes, 24, 48 and 72 hours following patch removal.
- Number of animals:
- 6 females.
- Details on study design:
- TEST SITE
- Area of exposure: no data
- % coverage: no data
- Type of wrap if used: no data
REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test material was removed, using reverse osmosis water and papers towels.
- Time after start of exposure: 4 hours
SCORING SYSTEM: according to the Draize Method of Scoring.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- No animal death prior to study termination.
Topical application of MRD-90-903 elicited no responses in any animal. - Other effects:
- No additional data.
Any other information on results incl. tables
Table 7.3.1/1:Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test
Score at time point / Reversibility |
Erythema |
Edema |
Max. score: 4 |
Max. score: 4 |
|
24 h |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
48 h |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
72 h |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
Average 24h, 48h, 72h |
0.0 |
0.0 |
Reversibility* |
- |
- |
Average time (unit) for reversion |
- |
- |
*Reversibility: c. = completely reversible;= not completely reversible; n. = not reversible
Applicant's summary and conclusion
- Interpretation of results:
- other: Not irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, MRD-90-903 is not classified as skin irritant according to the criteria of Annex VI of the Directive 67/548/EEC and the CLP Regulation 1272/2008.
- Executive summary:
In a primary dermal irritation study conducted as similar to OECD guideline N°404 in compliance with GLP, six young adult female New Zealand White rabbits were dermally exposed to 0.5 mL of MRD-90-903. Test sites were covered with a semi-occlusive dressing for 4 hours. The skin reactions were assessed at 45 minutes, 24, 48 and 72 hours after removal of the dressing. The mean score was calculated across 3 scoring times for all animals at 24, 48 and 72 hours after patch removal.
The mean scores over 24, 48 and 72 hours were 0.0 for erythema and for oedema.
Based upon the directive 67 /548/EEC and the CLP Regulation 1272/2008, MRD-90-903 is not considered as irritating to the rabbit skin.
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