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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 230-029-6 | CAS number: 6920-22-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26.9.1980-30.09.1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Pre OECD and pre-GLP study but well conducted according to draft OECD protocol.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Remarks:
- Draft guideline used of 1981 version
- GLP compliance:
- no
Test material
- Reference substance name:
- DL-hexane-1,2-diol
- EC Number:
- 230-029-6
- EC Name:
- DL-hexane-1,2-diol
- Cas Number:
- 6920-22-5
- Molecular formula:
- C6H14O2
- IUPAC Name:
- hexane-1,2-diol
- Reference substance name:
- 1,2-hexanediol
- IUPAC Name:
- 1,2-hexanediol
- Test material form:
- other: colourless liquid
- Details on test material:
- Purity > 97%
Density 0.95 g/ml
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- other: Russian Albino
- Details on test animals or test system and environmental conditions:
- 3 male and 3 female test animals were used, approx. 1 year of age. the animals were acclimized for 1 day. Animals were individually housed in stainless steel cages, receiving standardised food (Altromin) and water ad libitum. Room temperature was 22 ±1 °C and relative humidity 50-60% during the test period. A 12 hour light/12 hour dark period was maintained per day. cages were cleaned and desinfected prior to use.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- other: Traganth
- Controls:
- other: other areas on animal skin, treated equivalently but without test substance
- Amount / concentration applied:
- 0.5 ml test substance were suspended in 500 mg Traganth to ensure adsorption to skin without losses.
- Duration of treatment / exposure:
- 72 hours
- Observation period:
- observation period post exposure was scheduled for 14 days but was not required
- Number of animals:
- 3 female and 3 male
- Details on study design:
- both flanks of each animal were used, whereas the left side was exposed as is (clipped) and the right side clipped and artificially sacrifized at the skin surface avoiding bleeding and deeper skin lessions.
The test substance was applied for 4 hours and scores (according to Draize) were taken 1, 24, 48 and 72 hours following removal of the patches.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: sacrificed skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: sacrificed skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: sacrificed skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 0.17
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: sacrificed skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: sacrificed skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: sacrificed skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: sacrificed skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: sacrificed skin
- Irritant / corrosive response data:
- A single application of 0.5 ml 1,2-hexanediol was tolerated almost without reaction. Only animals 1, 2 and 6 showed a defined erythrem 1 hour following removal of patches (score 2), which disappeared almost entirely at the end of the 72 hour observation period. Thus, the substance is considered non-irritant. Systemic toxic effects were not observed and animal behaviour was normal. The pure vehicle applied as control was tolerated without any reaction.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance 1,2-hexanediol is not irritating to rabbit skin.
- Executive summary:
A single application of 0.5 ml 1,2-hexanediol was tolerated almost without reaction. Only animals 1, 2 and 6 showed a defined erythrema 1 hour following removal of patches (score 2), which disappeared almost entirely at the end of the 72 hour observation period. Thus, the substance is considered non-irritant. Systemic toxic effects were not observed and animal behaviour was normal. The pure vehicle applied as control was tolerated without any reaction.
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.
