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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 217-915-8 | CAS number: 2008-39-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19th Sep. 1991 - 03rd Oct. 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- test was conducted under occlusive conditions
- GLP compliance:
- yes
Test material
- Reference substance name:
- Dimethylammonium 2,4-dichlorophenoxyacetate
- EC Number:
- 217-915-8
- EC Name:
- Dimethylammonium 2,4-dichlorophenoxyacetate
- Cas Number:
- 2008-39-1
- Molecular formula:
- C8H6Cl2O3.C2H7N
- IUPAC Name:
- dimethylammonium 2,4-dichlorophenoxyacetate
- Details on test material:
- - Name of test material (as cited in study report): Aminopielik 600 SL
- Physical state: dark brown solution with intense, characeristic smell
- Analytical purity: 51.6% active substance expressed as 2,4-D acid
- Purity test date: 11th July 1991
- Other:
pH = 8
d = 1207 g/cm3 (at 20 °C)
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: New Zealand
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Rabbits Breeding S-52, Zator, Poland
- Age at study initiation: 3 - 6 months
- Weight at study initiation: 3.5 kg (mean)
- Housing: individually in cages (80 x 80 x 60 cm3)
- Diet: granulated standard food and hay, both ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 4
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- 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:
- 4 hours
- Observation period:
- 1, 24, 48 and 72 hours after patch removal
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: dorsal area of the trunk
- Type of wrap if used: gauze patch with test substance was held in place with non-irritating tape and covered with an occlusive dressing.
SCORING SYSTEM:
Animals were examined for signs of erythema and oedema.
The dermal irritation was evaluated according to the OECD guideline 404 (Draize).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: mean value of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects observed
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: mean value of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects observed
- Irritant / corrosive response data:
- No signs of erythema and oedema were observed during the study period.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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.
