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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 250-610-8 | CAS number: 31394-54-4
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study meets generally accepted scientific principles, acceptable for assessment.
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study meets generally accepted scientific principles, acceptable for assessment.
- 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:
- animal #1
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- other: Primary irritation score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0.25
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- other: Not specified
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- other: Not specified
- Irritant / corrosive response data:
- Very slight erythema (grade 1) noted on abraded sites of 3 of 6 rabbits and intact sites of 3 of 6 rabbits at 72 hours post application. No other dermal effects were noted in the study.
- Other effects:
- No effects.
- Interpretation of results:
- other: Irritating
- Remarks:
- Criteria used for interpretation of results: other: CLP
- Conclusions:
- The test substance was irritating to the skin based on persistent irritation at study termination.
- Executive summary:
This data is being read across from the source study that tested 2,2,4-trimethylpentane (isooctane) based on analogue read across.
The test substance was irritating to the skin based on persistent irritation at study termination.
Initial protocol did not include provision for observation until reversibility up until 14-day observation period. Even though complete reversibility was not observed it was anticipated as was observed with irritation in dermal LD50 study.
The test substance was irritating to the skin based on persistent irritation at study termination.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Exposure continued for 24 hours instead of 4 hours, no observations planned past 72 hours following initial application
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- yes
- Remarks:
- Exposure continued for 24 hours instead of 4 hours, no observations planned past 72 hours following initial application
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2,2,4-trimethylpentane
- EC Number:
- 208-759-1
- EC Name:
- 2,2,4-trimethylpentane
- Cas Number:
- 540-84-1
- Molecular formula:
- C8H18
- IUPAC Name:
- 2,2,4-trimethylpentane
- Details on test material:
- - Name of test material (as cited in study report): Iso-octane
- Analytical purity:100% pure commercial product
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- not specified
- Preparation of test site:
- other: abraded and intact
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- Single application for 24 hours
- Observation period:
- 72 hours
- Number of animals:
- 3 males, 3 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no (24-hour exposure)
-Time after start of exposure: 24 hours
SCORING SYSTEM: OECD Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- other: Primary irritation score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0.25
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- other: Not specified
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- other: Not specified
- Irritant / corrosive response data:
- Very slight erythema (grade 1) noted on abraded sites of 3 of 6 rabbits and intact sites of 3 of 6 rabbits at 72 hours post application. No other dermal effects were noted in the study.
- Other effects:
- No effects.
Any other information on results incl. tables
Initial protocol did not include provision for observation until reversibility up until 14-day observation period. Even though complete reversibility was not observed it was anticipated as was observed with irritation in dermal LD50 study.
The test substance was irritating to the skin based on persistent irritation at study termination.
Applicant's summary and conclusion
- Interpretation of results:
- other: Irritating
- Remarks:
- Criteria used for interpretation of results: other: CLP
- Conclusions:
- The test substance was irritating to the skin based on persistent irritation at study termination.
- Executive summary:
The test substance was irritating to the skin based on persistent irritation at study termination.
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.
