Registration Dossier

Administrative data

Description of key information

not skin irritant for rabbits
eye irritant for rabbits

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation / corrosion, other
Remarks:
points 8.1 and 8.2 of Annex VIII of REACH have been amended. Nevertheless, adequate information from existing in vivo skin irritation or eye irritation studies can still be used to fulfil the information requirement at any tonnage level.
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, meets generally accepted scientific principles, acceptable for assessment.
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Age: 12-14 weeks
Body weight: 2 -3 kg
Source: Kelintierfarm Madoerin AG, Fuellinsdorf CH
Acclimation: 5 days
Accomodation: Caged singly in metal cages equipped with an automatic cleaning and drinking system (Dipl. Ing. W. Ehret Gmbh, Emmendingen FRG
Temperature of 17-23 °C and with a humidity of 30-70%
Animals were exposed to artificial light for 12 hours daily
Diet: Nafag n. 814 (Gossau, CH) was fed ad libitum. The food was analysed and the results of contaminats are attached to the study report.
Water: community tap water
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
not specified
Amount / concentration applied:
An area of at least 6 cm2 was shaved on both flanks of the animals approx. 24 hours before treatmnet.
0.5 g of the test compound was applied to each test site on a 3 cm square surgical gauze pad (20 cm2).
This were covered with aluminium foil (36 mm2) and then covered with an occlusive dressing for 4 hours.
The dressing was wrapped with an adhesive tape (isoplast AG, CH).
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48 and 72 hours and for other 7 days
Number of animals:
3 male rabbits
Details on study design:
Twenty-four hours prior to the dermal application, the backs of the rabbits were shaved.
Irritation parameter:
erythema score
Basis:
other: mean of all animals
Time point:
other: 1, 24, 48 and 72 h
Score:
0
Reversibility:
no data
Irritation parameter:
edema score
Basis:
other: mean of all animals
Time point:
other: 1, 24, 48 and 72 h
Score:
0
Reversibility:
no data
Irritant / corrosive response data:
No irritation effect observed on all animals.
No destructions or irreversible alterations of the treated skin were observed. No corrosive effect was evident on the skin.
Other effects:
Coloration: in the area of application a clear visible red stained of the test skin was observed in animals 76 and 77 up to 48 hours and in animal 75 up to 72 hours which could be related to effects of the test article.
Toxic symptoms / mortality: no acute symptoms were observed during the test period and no mortality occurred.
Interpretation of results:
not irritating
Remarks:
OECD GHS
Conclusions:
Based on the test results, the tested item is to be considered as non-irritant to the skin of rabbits.
Executive summary:

The primary irritation score was assessed following OECD 404.

The results show no irritation on rabbit skin therefore the tested item is to be considered as non-irritant to skin under Regulation EC 1272/2008 .

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

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation, other
Remarks:
points 8.1 and 8.2 of Annex VIII of REACH have been amended. Nevertheless, adequate information from existing in vivo skin irritation or eye irritation studies can still be used to fulfil the information requirement at any tonnage level.
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, meets generally accepted scientific principles, acceptable for assessment.
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Age: 12-14 weeks
Body weight: 2 -3 kg
Source: Kelintierfarm Madoerin AG, Fuellinsdorf CH
Acclimation: 5 days
Accomodation: Caged singly in metal cages equipped with an automatic cleaning and drinking system (Dipl. Ing. W. Ehret Gmbh, Emmendingen FRG
Temperature of 17-23 °C and with a humidity of 30-70%
Animals were exposed to artificial light for 12 hours daily
Diet: Nafag n. 814 (Gossau, CH) was fed ad libitum. The food was analysed and the results of contaminats are attached to the study report.
Water: community tap water
Vehicle:
unchanged (no vehicle)
Controls:
other: the left eye serves as control
Amount / concentration applied:
0.1 g of the test substance
Duration of treatment / exposure:
eye lids close for 1 seconds
Observation period (in vivo):
up to 7 days
Number of animals or in vitro replicates:
3 males
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
24-72 hours all animals
Time point:
other: 24-72 hours
Score:
1.33
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
mean
Remarks:
all animals
Time point:
other: 24-72 hours
Score:
1
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
other: 24-72 hours
Score:
2
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
all animals
Time point:
other: 24-72 hours
Score:
1.33
Reversibility:
fully reversible within: 14 days
Irritant / corrosive response data:
The tested substance ahowed a primary irritation score of:
1.33 for cornea
1 for iris
2 for conjunctivae redness
1.33 for conjunctivae chemosis
when applied to the rabbit eye mucosa.
The effect was not reversible in 21 days except for chemosis which is fully reversible within 14 days.
Interpretation of results:
irritating
Remarks:
OECD GHS
Conclusions:
The tested substance needs to be considered irritant for rabbits eyes under Regulation CE 1272/2008.
Executive summary:

The ocular reactions were determined followign OECD 405.

The tested substance is considered to be irritant for the rabbits eyes based on the results needs to be classified as H319, Causes serious eye irritation under Regulation 1272/2008.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Based on the results the tested substance could ne considered not irritant for the skin and irritant for eyes.


Justification for selection of skin irritation / corrosion endpoint:
The study was performed on official guidelines

Justification for selection of eye irritation endpoint:
The study was performed on official guidelines

Effects on eye irritation: irritating

Justification for classification or non-classification

No classification for skin irritation/corrosion is warranted under Regulation EC n. 1272/2008

Classification for eye irritation/corrosion is warranted under Regulation EC n. 1272/2008: H319, Causes serious eye irritation