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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 443-800-9 | CAS number: 40031-31-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 29-12-1994
- Reliability:
- 1 (reliable without restriction)
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- OECD Guidel ines for Testing of Chemical s No. 404 "Acute Dermal Irritation/Corrosion" (adopted 17 July 1992)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- Method B4 in Commission Directive 92/69/ EEC (which constitutes Annex V of Council Directive 67/548/ EEC)
- Deviations:
- no
- Principles of method if other than guideline:
- NA
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- -
- EC Number:
- 443-800-9
- EC Name:
- -
- Cas Number:
- 40031-31-0
- Molecular formula:
- C4H8O4
- IUPAC Name:
- (3S)-1,3,4-trihydroxybutan-2-one
- Test material form:
- liquid: viscous
- Details on test material:
- NA
Constituent 1
impurity 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Three New Zealand White rabbits were used for the testing.
At the start of the study the animal s weighed 2. 12 2.20 kg and were twelve to sixteen weeks old.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- The amount of test substance dose was 0.5 mL per animal.
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- Approximately one hour following the removal of the patches, and 24, 48 and 72 hours l ater, the test sites were examined for evidence of primary irritation and scored according to the following scale from Draize J. H. , (1977) "Dermal and Eye Toxicity Tests" In: Principles and Procedures for Eval uating the Toxicity of Household Substances, National Academy of Sciences, Washington D.C. p. 31 .
- Number of animals:
- 3
- Details on study design:
- NA
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:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- 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
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- - no skin irritation after 4 hours
- no evidence of a corrosive effect - Other effects:
- Yel 1 ow-col oured staining was noted at al l treated skin sites throughout the study. The staining did not affect evaluation of skin responses.
Very sl ight erythema was noted at one treated skin site one hour after patch removal .
No skin reactions were noted at the 24-hour observation.
Any other information on results incl. tables
No remarks
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material when applied as a 20% aqueous dilution produced a primary irritation index of 0.0 and was classified as a NON-IRRITANT to rabbit skin according to the Draize cl assification scheme. No corrosive effects were noted.
- Executive summary:
The test material when applied as a 20% aqueous dilution produced a primary irritation index of 0.0 and was classified as a NON-IRRITANT to rabbit skin according to the Draize cl assification scheme. No corrosive effects were noted.
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.
