Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

Administrative data

Description of key information

A skin irritation/corrosion study was performed according to OECD Guideline 404 and GLP principles and an eye irritation/corrosion study was performed according to OECD Guideline 405 and GLP principles. Based on the results of these studies, the substance is not irritating/corrosive to skin and eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
01 November, 1994 - 04 November, 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study has been performed according to OECD and/or EC guidelines and according to GLP principles.
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
(1992)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
(1992)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: Approx. 8-9 weeks
- Weight at study initiation: 1495 - 1725 g
- Housing: Individually housed in labelled cages with perforated floors.
- Diet: Free access to standard laboratory rabbit diet (LKK-20, pellet diameter 4mm, Hope Farms, Woerden, The Netherlands)
- Water: Free access to tap-water diluted with decalcified water
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 50
- Air changes (per hr): approx. 15
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: The test substance was moistened with distilled water.
Controls:
other: The untreated contralateral flank of each animal served as controls
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 grams

VEHICLE
The test substance was moistened with vehicle.
Duration of treatment / exposure:
Single application
Observation period:
14 days
Number of animals:
3 males
Details on study design:
TEST SUBSTANCE PREPARATION
The test substance was ground to a powder using a mortar and pestle. Subsequently, the test substance was moistened with distilled water, immediately before application, to ensure close contact to the animal's skin.

TEST SITE
Approximately 24 hours before treatment, the dorsal fur was shaved with electric clippers, exposing an area of approximately 150 square centimeters (10x15 cm). Whenever considered necessary to facilitate scoring, treated skin areas were re-clipped at least 3 hours before the observations.

The test substance was applied to the skin of one flank, using a Scotchpak non-woven patch of 2x3 cm.

REMOVAL OF TEST SUBSTANCE
Four hours after the application, the dressing was removed and the skin cleaned of residual test substance using a tissue with tap water and subsequently a dry tissue.

OBSERVATIONS (kort allemaal!)
- Mortality/Viability: Twice daily.
- Toxicity: At least once daily.
- Body Weight: Day of treatment (prior to application)
- Necropsy: not performed
- Irritation:
The skin reactions were assessed at approximately 1, 24, 48 and 72 hours after the removal of the dressings and test substance. The irritation scores and a description of all other (local) effects were recorded.

SCORING SYSTEM:
The irritation was assessed according to the numerical scoring system according to OECD 404.
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #1, #2 and #3
Time point:
other: 24, 48 and 72 hours.
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #1, #2 and #3
Time point:
other: 24, 48 and 72 hours.
Score:
0
Max. score:
4
Irritant / corrosive response data:
No signs of skin irritation were observed in the treated skin-areas of any of the three rabbits after 4 hours exposure to KY-RB, during the 72 hours observation period. There was no evidence of a corrosive effect on the skin.
Other effects:
No staining of the treated skin by the test substance was observed.
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In a skin irritation study with KY-RB with rabbits, performed according to OECD 404 test guideline and GLP principles, no irritation was observed.
Executive summary:

KY-RB was tested in a skin irritation study with male rabbits, performed according to OECD 404 test guideline and GLP principles.

No signs of skin irritation were observed in the treated skin-areas of any of the three rabbits after 4 hours exposure to KY-RB, during the 72 hours observation period. There was no evidence of a corrosive effect on the skin.

Based on the results, KY-RB does not have to be classified for skin irritation according to Regulation (EC) No 1272/2008.

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:
07 November, 1994 - 10 November, 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study has been performed according to OECD and/or EC guidelines and according to GLP principles.
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
(1987)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
(1992)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: Approx. 9 weeks
- Weight at study initiation: 1589 - 2106 g
- Housing: Individually housed in labelled cages with perforated floors.
- Diet: Standard laboratory rabbit diet (LKK-20, pellet diameter 4mm, Hope Farms, Woerden, The Netherlands) approx. 100 g per day
- Water: Free access to tap-water diluted with decalcified water
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 50
- Air changes (per hr): approx. 15
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
other: One eye of each animal remained untreated and served as the reference control.
Amount / concentration applied:
TEST MATERIAL- Amount applied: 26 ± 2 mg (a volume of approximately 0.1 mL)
Duration of treatment / exposure:
Single instillation on Day 1.
Observation period (in vivo):
The eyes of each animal were examined approximately 1, 24, 48 and 72 hours after instillation of the test substance.
Number of animals or in vitro replicates:
3 males
Details on study design:
TREATMENT
On test day 1, the test substance was instilled in the conjunctival sac of one eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of the test substance.

REMOVAL OF TEST SUBSTANCE
-Washing: No

OBSERVATIONS
- Mortality/Viability: Twice daily.
- Toxicity: At least once daily.
- Body Weight: Day of treatment (prior to instillation).
- Necropsy: not performed.
- Irritation:
The eyes of each animal were examined approximately 1, 24, 48 and 72 hours after instillation of the test substance.
The irritation scores and a description of all other (local) effects were recorded. The irritation was assessed according to OECD 405.
Irritation parameter:
cornea opacity score
Remarks:
(opacity)
Basis:
mean
Remarks:
animal #1, #2 and #3
Time point:
other: 24, 48 and 72 hrs.
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #1, #2 and #3
Time point:
other: 24, 48 and 72 hrs.
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Remarks:
animal #1 and #2
Time point:
other: 24, 48 and 72 hrs.
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Remarks:
(mean)
Time point:
other: 24, 48 and 72 hrs.
Score:
0.66
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #1, #2 and #3
Time point:
other: 24, 48 and 72 hrs.
Score:
0
Max. score:
4
Irritant / corrosive response data:
Slight redness of the conjuctival tissues was observed in all animals. The irritation had resolved within 48 hours in two animals and within 72 hours after instillation in the third animal. There was no evidence of ocular corrosion.
Treatment of the eyes with 2% fluorescein, 24 hours after test substance instillation revealed no corneal epithelial damage in any of the animals.
Other effects:
Remnants of the test substance were noted on the outside of the eyelids in one animal during the observation period.
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In an eye irritation study with KY-RB with male rabbits, performed according to OECD 405 test guideline and GLP principles, limited irritation was observed.
Executive summary:

KY-RB was tested in an eye irritation study with male rabbits, performed according to OECD 405 test guideline and GLP principles.

No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Slight redness of the conjuctival tissues was observed in all animals. The irritation had resolved within 48 hours in two animals and within 72 hours after instillation in the third animal. There was no evidence of ocular corrosion.

Based on the results, KY-RB does not have to be classified for eye irritation according to Regulation (EC) No 1272/2008.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin:

KY-RB was tested in a skin irritation study with male rabbits, performed according to OECD 404 test guideline and GLP principles.

No signs of skin irritation were observed in the treated skin-areas of any of the three rabbits after 4 hours exposure to KY-RB, during the 72 hours observation period. There was no evidence of a corrosive effect on the skin.

Eye:

KY-RB was tested in an eye irritation study with male rabbits, performed according to OECD 405 test guideline and GLP principles.

No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Slight redness of the conjuctival tissues was observed in all animals. The irritation had resolved within 48 hours in two animals and within 72 hours after instillation in the third animal. There was no evidence of ocular corrosion.


Justification for selection of skin irritation / corrosion endpoint:
One in vivo study available.

Justification for selection of eye irritation endpoint:
One in vivo study available.

Justification for classification or non-classification

Based on the results, KY-RB does not have to be classified for skin and eye irritation according to Regulation (EC) No 1272/2008.