Registration Dossier
Registration Dossier
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EC number: 927-285-2 | CAS number: 1174522-15-6
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:
- 2000/4/12-2000/6/22
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: According to OECD test guideline 404. GLP
- Justification for type of information:
- A discussion and report on the read across strategy is given 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:
- 2000/4/12-2000/6/22
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: According to OECD test guideline 404. GLP
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- ca. 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 13 days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- ca. 1.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 13 days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- ca. 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 13 days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.9
- Max. score:
- 2
- Reversibility:
- fully reversible within: 13 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- ca. 1.3
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- ca. 1
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- ca. 1
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.1
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- Topical application of Petrepar 134 (50/50) elicited dermal responses in all animals. Well defined erythema and slight edema followed exposure and was resolved by day 13.
- Interpretation of results:
- other: R38 under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations. Not classified under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The average erythema score (24,48, and 72 hours) was 1.9, with 2 out of 3 animals having a mean (24-72 hour) erythema score of 2.0. The average edema score (24,48, and 72 hours) was 1.1. Based on the individual animal dermal irritation scores, the test substance warrants classification of the test material as a skin irritant (R38) under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations. Classification as a dermal irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).
- Executive summary:
This data is being read across from the source study that tested Hydrocarbons, C11-C14, n-alkanes, <2% aromatics based on analogue read across.
In this study, 3 rabbits were subjected to a 4h dermal (shaved) exposure of 0.5 ml of Petrepar 134 (50/50) via a semi-occluded patch. Dermal responses were evaluated at 1, 24, 48, and 72h post-dosing and once a day for a total of 14 days according to the Draize method of scoring. Topical application of Petrepar 134 (50/50) elicited dermal responses in all animals. Well defined erythema and slight oedema followed exposure and was resolved by day 13. The average erythema score (24,48, and 72 hours) was 1.9, with 2 out of 3 animals having a mean (24-72 hour) erythema score of 2.0. The average edema score (24,48, and 72 hours) was 1.1. Based on the individual animal dermal irritation scores, the test substance warrants classification of the test material as a skin irritant (R38) under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations. Classification as a dermal irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Hydrocarbons, C11-C14, n-alkanes, <2% aromatics
- EC Number:
- 924-803-9
- Molecular formula:
- not available - UVCB
- IUPAC Name:
- Hydrocarbons, C11-C14, n-alkanes, <2% aromatics
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
Source:Harlan UK Ltd
Number of Animals: Three
Age at study initiation: Approximately 13 weeks
Weight at study initiation: 2.7-3.2 kg
Housing: Individually
Diet (e.g. ad libitum): Special Diet Service STANRAB SQC (pellets); ad libitum
Water (e.g. ad libitum): Automatic watering system, ad libitum
Acclimation period: 22d
ENVIRONMENTAL CONDITIONS
Temperature (°C): 18-21
Humidity (%): 53-65%
Photoperiod (hrs dark / hrs light): 12/12
Monitored at least once a day
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- Amount(s) applied (volume or weight): 0.5 ml
Concentration (if solution): neat - Duration of treatment / exposure:
- Test material was administered to the clipped backs as a single dose introduced under a gauze patch (secured with non-irritating tape) and held in contact with the skin by means of a semi-occlusive dressing for 4 hours. Residual test material was then removed.
- Observation period:
- 24, 48, and 72h post application and once per day until Day 14
- Number of animals:
- Three females
- Details on study design:
- SCORING SYSTEM: Draize scale for dermal irritation
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- ca. 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 13 days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- ca. 1.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 13 days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- ca. 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 13 days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.9
- Max. score:
- 2
- Reversibility:
- fully reversible within: 13 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- ca. 1.3
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- ca. 1
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- ca. 1
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.1
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- Topical application of Petrepar 134 (50/50) elicited dermal responses in all animals. Well defined erythema and slight edema followed exposure and was resolved by day 13.
Applicant's summary and conclusion
- Interpretation of results:
- other: R38 under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations. Not classified under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The average erythema score (24,48, and 72 hours) was 1.9, with 2 out of 3 animals having a mean (24-72 hour) erythema score of 2.0. The average edema score (24,48, and 72 hours) was 1.1. Based on the individual animal dermal irritation scores, the test substance warrants classification of the test material as a skin irritant (R38) under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations. Classification as a dermal irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).
- Executive summary:
In this study, 3 rabbits were subjected to a 4h dermal (shaved) exposure of 0.5 ml of Petrepar 134 (50/50) via a semi-occluded patch. Dermal responses were evaluated at 1, 24, 48, and 72h post-dosing and once a day for a total of 14 days according to the Draize method of scoring. Topical application of Petrepar 134 (50/50) elicited dermal responses in all animals. Well defined erythema and slight oedema followed exposure and was resolved by day 13. The average erythema score (24,48, and 72 hours) was 1.9, with 2 out of 3 animals having a mean (24-72 hour) erythema score of 2.0. The average edema score (24,48, and 72 hours) was 1.1. Based on the individual animal dermal irritation scores, the test substance warrants classification of the test material as a skin irritant (R38) under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations. Classification as a dermal irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).
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