Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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: 297-628-2 | CAS number: 93685-80-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2000/10/12-2000/10/18
- 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:
- 2000/10/12-2000/10/18
- 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: 14 days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- ca. 2.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- ca. 2.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- ca. 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- ca. 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- ca. 1.7
- 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:
- All animals survived to study termination, were free of adverse clinical signs, and displayed normal body weight patterns during the test period.
Topical application of the test substance to the skin of rabbits elicited dermal irritation in all animals during the study. Erythema and edema were observed in all animals.
Erythema started as Grade 2 erythema in all animals at the 60-minute evaluation and remained the same at the 24-hour evaluation. Erythema increased slightly at the 48- hour evaluation when two animals displayed Grade 2 erythema and one animal displayed Grade 3 erythema. Erythema reached its maximum severity at the 72- hour evaluation when one animal displayed Grade 2 erythema and two animals displayed Grade 3 erythema. Erythema subsided after the 72-hour evaluation and on Days 7 and 10 all animals displayed Grade 1 erythema. At the Day 14 evaluation one animal displayed Grade 1 erythema.
Edema was first noted and was most severe at the 60-minute evaluation. Grade 2 edema was noted for all animals at this interval. Edema decreased slightly at the 24 and 48-hour evaluations when Grade 1 edema was noted in two animals and Grade 2 edema was noted in one animal. Edema increased slightly at the 72-hour evaluation when one animal displayed Grade 1 edema and two animals displayed Grade 2 edema. At the Day 7 evaluation Grade 1 edema was displayed by two animals and Grade 3 edema was displayed for one animal. After the Day 7 evaluation edema subsided. One animal displayed Grade 2 edema at Day 10 and one animal displayed Grade 1 edema at Day 14.
Supplemental dermal observations, which included desquamation and cracking, were noted on Days 7 and 10. Desquamation was noted for all animals at both intervals and cracking was noted for one animal on Day 7. - Interpretation of results:
- other: Irritating
- Remarks:
- R38 Criteria used for interpretation of results: EU
- Conclusions:
- The average erythema score (24, 48, and 72 hours) was 2.33. The average edema score (24, 48, and 72 hours) was 1.1. The test material would be classified as a Category 2 dermal irritant under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP). The test material would be classified as an R38 dermal irritant under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
- Executive summary:
This data is being read across from the source study that tested Hydrocarbons, C10-C12, isoalkanes, <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 MRD-00-710 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 MRD-00-710 elicited dermal responses in all animals. Well defined erythema and slight odema followed exposure. The average erythema score (24, 48, and 72 hours) was 2.33. The average edema score (24, 48, and 72 hours) was 1.1. The test material would be classified as a Category 2 dermal irritant under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP). The test material would be classified as an R38 dermal irritant under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2001
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, C10-C12, isoalkanes, <2% aromatics
- EC Number:
- 923-037-2
- Molecular formula:
- (CH2)6-8C4H10
- IUPAC Name:
- Hydrocarbons, C10-C12, isoalkanes, <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:Covance Research Products Inc.
Number of Animals: Three males
Age at study initiation: Approximately 13 weeks
Weight at study initiation: 2.7-3.2 kg
Housing: Individually
Diet (e.g. ad libitum): PMI Cert. Rabbit Diet; limited
Water (e.g. ad libitum): Automatic watering system, ad libitum
Acclimation period: 8d
ENVIRONMENTAL CONDITIONS
Temperature (°F): 64 to 72
Humidity (%): 30 to 70%
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 males
- 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: 14 days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- ca. 2.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- ca. 2.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- ca. 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- ca. 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- ca. 1.7
- 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:
- All animals survived to study termination, were free of adverse clinical signs, and displayed normal body weight patterns during the test period.
Topical application of the test substance to the skin of rabbits elicited dermal irritation in all animals during the study. Erythema and edema were observed in all animals.
Erythema started as Grade 2 erythema in all animals at the 60-minute evaluation and remained the same at the 24-hour evaluation. Erythema increased slightly at the 48- hour evaluation when two animals displayed Grade 2 erythema and one animal displayed Grade 3 erythema. Erythema reached its maximum severity at the 72- hour evaluation when one animal displayed Grade 2 erythema and two animals displayed Grade 3 erythema. Erythema subsided after the 72-hour evaluation and on Days 7 and 10 all animals displayed Grade 1 erythema. At the Day 14 evaluation one animal displayed Grade 1 erythema.
Edema was first noted and was most severe at the 60-minute evaluation. Grade 2 edema was noted for all animals at this interval. Edema decreased slightly at the 24 and 48-hour evaluations when Grade 1 edema was noted in two animals and Grade 2 edema was noted in one animal. Edema increased slightly at the 72-hour evaluation when one animal displayed Grade 1 edema and two animals displayed Grade 2 edema. At the Day 7 evaluation Grade 1 edema was displayed by two animals and Grade 3 edema was displayed for one animal. After the Day 7 evaluation edema subsided. One animal displayed Grade 2 edema at Day 10 and one animal displayed Grade 1 edema at Day 14.
Supplemental dermal observations, which included desquamation and cracking, were noted on Days 7 and 10. Desquamation was noted for all animals at both intervals and cracking was noted for one animal on Day 7.
Applicant's summary and conclusion
- Interpretation of results:
- other: Irritating
- Remarks:
- R38 Criteria used for interpretation of results: EU
- Conclusions:
- The average erythema score (24, 48, and 72 hours) was 2.33. The average edema score (24, 48, and 72 hours) was 1.1. The test material would be classified as a Category 2 dermal irritant under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP). The test material would be classified as an R38 dermal irritant under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
- Executive summary:
In this study, 3 rabbits were subjected to a 4h dermal (shaved) exposure of 0.5 ml of MRD-00-710 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 MRD-00-710 elicited dermal responses in all animals. Well defined erythema and slight odema followed exposure. The average erythema score (24, 48, and 72 hours) was 2.33. The average edema score (24, 48, and 72 hours) was 1.1. The test material would be classified as a Category 2 dermal irritant under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP). The test material would be classified as an R38 dermal irritant under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
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.
