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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 619-642-3 | CAS number: 106-78-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2000-08-24 to 2000-08-27
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-{2-[(2-chloroacetyl)oxy]ethoxy}ethyl 2-chloroacetate
- Cas Number:
- 106-78-5
- Molecular formula:
- C8H12O5Cl2
- IUPAC Name:
- 2-{2-[(2-chloroacetyl)oxy]ethoxy}ethyl 2-chloroacetate
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: LPT
- Age at study initiation: 7.5 months
- Weight at study initiation: 2.4 - 2.8 kg
- Housing: During the exposure period the animals were kept singly in special restrainers which allowed free movement of the head but prevented a complete body turn. Before and after the 4-hour exposure period the rabbits were kept separately in cages with dimensions of 425 mm x 600 mm x 380 mm.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 20 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 3°C
- Humidity (%): 50% ± 20%
- Photoperiod (hrs dark / hrs light): 12 hours/12 hours
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- 0.5 ml/patch and animal, once epicutaneous
NEGATIVE CONTROL
- The surrounding untreated skin served as a control.
POSITIVE CONTROL
- no - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: approx. 6 cm^2
- Type of wrap if used: Test site covered with a gauze patch. The patch was held in contact with the skin by means of a semi-occlusive dressing.
OBSERVATION TIME POINTS
- 60 minutes, 24,48,72 hours after patch removal
SCORING SYSTEM:
Erythema and Eschar Formation:
0 = no erythema
1 = very slight erythema (barely perceptible)
2 = well-defined erythema
3 = moderate to severe erythema
4 = severe erythema (beet rednessl to slight eschar formation (injuries in depth) preventing erythema reading
Oedema Formation:
0 = no oedema
1 = very slight oedema (barely perceptible)
2 = slight oedema (edges of area well defined by definite raising)
3 = moderate oedema (raised approx. 1 mm)
4 = severe oedema (raised more than 1 mm and extending beyond area of exposure)
If other lesions occur, they will be listed.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: animal #1, animal #2 and animal #3
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal: animal #1, animal #2 and animal #3
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal: animal #1, animal #2 and animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal: animal #1, animal #2 and animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
Any other information on results incl. tables
There were no systemic intolerance reactions.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Non-irritating to skin
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.
