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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 237-396-1 | CAS number: 13770-89-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22 November 1996 - 6 December 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study according to OECD Guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Nickel Sulfamate-4-Hydrate
- IUPAC Name:
- Nickel Sulfamate-4-Hydrate
- Reference substance name:
- Nickel bis(sulphamidate)
- EC Number:
- 237-396-1
- EC Name:
- Nickel bis(sulphamidate)
- Cas Number:
- 13770-89-3
- Molecular formula:
- Ni(NH2SO3)2
- IUPAC Name:
- nickel(2+) disulfamate
- Details on test material:
- - Name of test material (as cited in study report): NICKELSULFAMATE-4-HYDRATE
- Physical state: green crystalline solid
- Lot/batch No.: 61210
- Storage condition of test material: ambient temperature « 25 0 C), stored under artificial light
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.40-2.53 kg
- Housing: individual susppended metal cages
- Diet (e.g. ad libitum): free access
- Water (e.g. ad libitum): free access
- Acclimation period: minimum 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-19 C
- Humidity (%): 46-64%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.5g
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 ml water - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: surgical adhesive tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): gentle swabbing with cotton wool soaked in water
- Time after start of exposure: 4 hours
SCORING SYSTEM: according to the following scale from Draize J H, (1977) "Dermal and Eye Toxicity Tests" In: Principles and Procedures for Evaluating the Toxicity of Household Substances, National Academy of Sciences, Washington DC p.31.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24 and 72 hours
- Score:
- 1.8
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal: 4
- Time point:
- other: 1 hr
- Score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal: 4
- Time point:
- 24/48 h
- Score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal: 4
- Time point:
- 72 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal: 4
- Time point:
- 7 d
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal: 4
- Time point:
- 14 d
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal: 10
- Time point:
- other: 1 hr
- Score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal: 10
- Time point:
- 24/48/72 h
- Score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal: 10
- Time point:
- 7 d
- Score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- other: crust formation
- Irritation parameter:
- erythema score
- Basis:
- animal: 10
- Time point:
- 14 d
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal: 11
- Time point:
- other: 1 hr
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal: 11
- Time point:
- 24/48 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal: 11
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal: 11
- Time point:
- 7 d
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal: 11
- Time point:
- 14 d
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal: 4
- Time point:
- other: 1 hr
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal: 4
- Time point:
- 24/48 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal: 4
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal: 4
- Time point:
- 7 d
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal: 4
- Time point:
- 14 d
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal: 10
- Time point:
- other: 1 hr
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal: 10
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal: 10
- Time point:
- 7 d
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal: 10
- Time point:
- 14 d
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal: 11
- Time point:
- other: 1 hr
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal: 11
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal: 11
- Time point:
- 7 d
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal: 11
- Time point:
- 14 d
- Score:
- 0
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- No corrosive effects were noted
- Other effects:
- Very slight to well-defined erythema and very slight oedema observed.
Crust formation was also noted at one treated skin site.
Any other information on results incl. tables
Well-defined erythema was noted at two treated skin sites with very slight erythema at the remaining treated skin site one hour after patch removal and at the subsequent 24 and 48-hour observations. Well-defined erythema was noted at one treated skin site with very slight erythema at one other treated skin site at the 72-hour observation. Very slight erythema was noted at one treated skin site at the 7-day observation. No other evidence of erythema was noted. Very slight oedema was noted at all treated skin sites one hour after patch removal, at two treated skin sites at the 24 and 48-hour observations and persisted at one treated skin site at the 72-hour observation. No other evidence of oedema was noted. Crust formation was noted at one treated skin site at the 7-day observation. Treated skin sites appeared normal at the 14-day observation.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
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.
