Registration Dossier
Registration Dossier
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EC number: 943-665-0 | CAS number: -
Endpoint summary
Administrative data
Description of key information
The substnace is not a dermal irritant.
The substance is not an eye irritant.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation / corrosion, other
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The study was conducted between 20 October 2015 and 23 October 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes
- Specific details on test material used for the study:
- Lot/Batch PW"
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Covance Research Products, Inc., Denver, PA, USA
- Age at study initiation: ~28 wks
- Weight at study initiation: 2.8-3.1 kg
- Housing: individually in suspended cages
- Diet (e.g. ad libitum): daily
- Water (e.g. ad libitum): ad libitum
- Acclimation period: >5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): controlled
- Humidity (%): not stated
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 20 October 2015 To: 23 October 2015 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g per site
- Concentration (if solution):
VEHICLE
- Amount(s) applied (volume or weight with unit): 1.5 ml
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:
NEGATIVE CONTROL
- Amount(s) applied (volume or weight):
- Concentration (if solution):
POSITIVE CONTROL
- Amount(s) applied (volume or weight):
- Concentration (if solution): - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3; 2 male 1 female
- Details on study design:
- TEST SITE
- Area of exposure:
- % coverage:
- Type of wrap if used:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): gentel washing with distilled water
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
(indicate if minutes, hours or days) 1, 24 48 and 72 hours
SCORING SYSTEM:
- Method of calculation: Draze Technique - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 0.42h
- Score:
- > 0 - < 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 0.42h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No dermal irritant effects
- Interpretation of results:
- other: Not a dermal irritant
- Conclusions:
- RD 14153 is not a dermal irritant
- Executive summary:
RD 14153 is not a dermal irritant
Reference
Very slight Erythema in one rabbit at 1h time point, no erythema or edema effects seen in any other animlas at any time point
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- the study was conducted between 20 October 2015 and 23 October 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- not specified
- GLP compliance:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Sponsor Lot/Batch No. PW2
- Expiration date of the lot/batch:
- Purity test date:06 Oct 2015
RADIOLABELLING INFORMATION (if applicable)
- Radiochemical purity:
- Specific activity:
- Locations of the label:
- Expiration date of radiochemical substance:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
- Stability under test conditions:
- Solubility and stability of the test substance in the solvent/vehicle:
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium:
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing:
- Preliminary purification step (if any):
- Final dilution of a dissolved solid, stock liquid or gel:
- Final preparation of a solid:
FORM AS APPLIED IN THE TEST (if different from that of starting material)
OTHER SPECIFICS: - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Covance Research Products, Inc. Denver, PA, USA
- Age at study initiation: 28 wks
- Weight at study initiation: 2.9-3.4 kg
- Housing: Individually in suspended cages
- Diet (e.g. ad libitum): Fresh daily
- Water (e.g. ad libitum): ad libitum
- Acclimation period: > 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): controlled but no temperature reported
- Humidity (%): controlled but no humidity reported
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):12/12
IN-LIFE DATES: From: 20 October 2015 To: 23 October 2015 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- other: Contralateral eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 21.6 mg
- Concentration (if solution):
VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity: - Duration of treatment / exposure:
- 72h
- Observation period (in vivo):
- 72h
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not done
- Time after start of exposure:
SCORING SYSTEM: Draize technique
TOOL USED TO ASSESS SCORE: hand lamp - Mini-Maglite with high intensity bulb
fluorescein dye at 24h timepoint with UV light source - Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 1h
- Score:
- >= 6
- Max. score:
- 6
- Reversibility:
- fully reversible
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 1h
- Score:
- 8
- Max. score:
- 8
- Reversibility:
- fully reversible
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 1h
- Score:
- 8
- Max. score:
- 8
- Reversibility:
- fully reversible
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: all
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal: all
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: all
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal: all
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- Corneal opacity and iritis were not noted at any observation period, Conjunctival irritation, noted in three out of three eyes at the 1-hour observation period, cleared by 24 hours.
Additional ocular observations of test article residue in the conjunctival sac were noted at the 1-hour observation period.
The control eyes appeared normal at all observation periods. - Other effects:
- - Lesions and clinical observations:
- Ophthalmoscopic findings:
- Histopathological findings:
- Effects of rinsing or washing:
- Other observations: No physical signe were noted during the observation period.
One animal lest weight, one animal gained weight and one anim's weight remained unchanged. - Interpretation of results:
- other: Non irritant
- Conclusions:
- Corneal opacity and iritis were not noted at any observation period, Conjunctival irritation, noted in three out of three eyes at the 1-hour observation period, cleared by 24 hours.
Additional ocular observations of test article residue in the conjunctival sac were noted at the 1-hour observation period.
The control eyes appeared normal at all observation periods.
The substance was non irritant and is not classified according to EU and GHS classifications and is classified as Category IV under the US EPA Classification - Executive summary:
The eye irritation/corrosion effects of RD 14153 were examined in accordance with OECD 405 and US EPA OCSPP 870.2400 guidelines in three New Zealand White Rabbits over a period of 72 hours; one eye per rabbit was treated, the other acted as a control.
Corneal opacity and iritis were not noted at any observation period, Conjunctival irritation, noted in three out of three eyes at the 1-hour observation period, cleared by 24 hours. Additional ocular observations of test article residue in the conjunctival sac were noted at the 1-hour observation period. The control eyes appeared normal at all observation periods.
The substance was non irritant and is not classified according to EU and GHS classifications and is classified as Category IV under the US EPA Classification
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In a study to investigate skin irritation, very slight Erythema was observed in one rabbit at 1h time point, no erythema or edema effects seen in any other animlas at any time point.
In a study to investigate eye irritation, corneal opacity and iritis were not noted at any observation period, Although conjunctival irritation, was noted in three out of three eyes at the 1 -hour observation period, it cleared by 24 hours in all cases. Additional ocular observations of test article residue in the conjunctival sac were noted at the 1-hour observation period.
Justification for classification or non-classification
The substance has been tested and found not to be a skin irritant.
The substance has been tested and found not to be an eye irritant.
In accordance with the classifciation criteria described in CLP Regulation 1272/2008 the substance is not classified for skin irritation or eye irritation..
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.
