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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 260-300-4 | CAS number: 56634-95-8
Toxicological information
Skin irritation / corrosion
Currently viewing:
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11 - 21 Jul 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted 2015
- Deviations:
- yes
- Remarks:
- Age and weight of animals not reported, environmental and general conditions of animals not reported, no data on untreated skin
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-5 (Acute Dermal Irritation)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2,6-dibromo-4-cyanophenyl heptanoate
- EC Number:
- 260-300-4
- EC Name:
- 2,6-dibromo-4-cyanophenyl heptanoate
- Cas Number:
- 56634-95-8
- Molecular formula:
- C14H15Br2NO2
- IUPAC Name:
- 2,6-dibromo-4-cyanophenyl heptanoate
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ray Nichols Rabbitry, Lumberton, Texas, USA
- Age at study initiation: Young adults
- Weight at study initiation: not specified
- Housing: individually in suspended, wire bottom, stainless steel cages
- Diet: Purina Rabbit Chow, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): not specified
- Humidity (%): not specified
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): not specified
IN-LIFE DATES: From: 11 To: 21 Jul 1989
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 mL
- Concentration: 100% actual test material as received
- The test item has been liquified by heating to 45 °C prior to treatment. - Duration of treatment / exposure:
- 4 h
- Observation period:
- 10 days
- Number of animals:
- 3 per sex
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: a surgical gauze patch, held in place by non-irritating adhesive tape covered by semi-permeable dressing (orthopedic stockinette) loosely wrapped around the trunk of the animal
REMOVAL OF TEST SUBSTANCE
- Washing: test sites were gently washed with tap water and gauze
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS
1, 24, 48 and 72 h; 7 and 10 days after washing
SCORING SYSTEM:
- Method of calculation: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- male
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- male
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- male
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Remarks:
- female
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Remarks:
- female
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Remarks:
- female
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- male
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- male
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- male
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Remarks:
- female
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Remarks:
- female
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Remarks:
- female
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritant / corrosive response data:
- All rabbits had erythema and edema that persisted through Day 7. The majority of edemas observed were very slight, scored with grade 1 in 5/6 animals. Well-defined erythemas were noted in all rabbits. 1 h after washing 3/6 animals revealed erythema of very mild degree (score 1). The remaining 3 animals showed erythema of grade 2. Ath the 24 h reading time point, 5/6 rabbits showed erythema of mild degree scored with grade 2. No skin reactions were noted latest on Day 10.
- Other effects:
- In individual cases sloughing of the skin of various thicknesses was observed at the 7 and 10 days reading time point.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- The study is in accordance with EPA guideline no. 81-5 and was conducted under GLP conditions. Although the study possesses deviations from the current OECD guideline no. 404 (skin irritation), such as missing information on age and weight of animals, environmental and general conditions of animals, and no data on untreated skin, it is considered valid and reliable. Under the conditions chosen the test substance did not induce skin irritation to rabbits. According to criteria of the CLP Regulation (EU) No. 1272/2008, no classification of the test item for skin irritation is required.
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.
