Registration Dossier

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
Reference
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:
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 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

Very slight Erythema in one rabbit at 1h time point, no erythema or edema effects seen in any other animlas at any time point

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

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
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:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
Qualifier:
equivalent or similar to
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

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..