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:
other: experimental data on similar substance
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: 15-16 weeks
Body weight: 2.1 -2.7 kg
Source: Kelintierfarm Madoerin AG, Fuellinsdorf CH
Acclimation: 4 days under test conditions after veterinary control.
Accomodation: Caged singly in stainless steel cages equipped with an automatic cleaning and drinking system (Dipl. Ing. W. Ehret Gmbh, Emmendingen FRG D
Temperature of 22°C and with a humidity of 40-70%.
Animals were exposed to artificial light for 12 hours daily, Music/light period.
Diet: Pelleted standard Kliba 341, Batch 11/85 rabbit maintenance diet (Kliba, Klingentalmuehle AG, Kaiseraugst CH) was fed ad libitum. The food was analysed and the results of contaminats are attached to the study report.
Water: community tap water from Itingen ad libitum. The water was analysed and the results are attached to the study report.
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
not specified
Amount / concentration applied:
0.5 g of the test compound was applied to each test site on a 3 cm square surgical gauze pad.
This were covered with aluminium foil and then covered with an occlusive dressing. The dressing was wrapped around the abdomen and anchored with an elastic bandage.
Duration of treatment / exposure:
no data
Observation period:
1, 24, 48 and 72 hours
Number of animals:
2 males, 1 female
Details on study design:
Twenty-four hours prior to the dermal application, the backs of the rabbits were shaved with an electric clipper over an area consisting of 100 square centimeters (10 cm x 10 cm)
Irritation parameter:
erythema score
Basis:
other: all animals
Time point:
other: 1, 24, 48 and 72 h
Score:
0
Reversibility:
no data
Irritation parameter:
edema score
Basis:
other: 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. The primary irritation index was 0 when applied to intact skin.
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 brownish disocloration of the test skin was observed 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:
GHS criteria not met
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:
other: experimental data on similar substance
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: 15-16 weeks
Body weight: 2.4 -2.8 kg
Source: Kelintierfarm Madoerin AG, Fuellinsdorf CH
Acclimation: 4 days under test conditions after veterinary control.
Accomodation: Caged singly in stainless steel cages equipped with an automatic cleaning and drinking system (Dipl. Ing. W. Ehret Gmbh, Emmendingen FRG D
Air conditioned with 10-15 air chnages per hour and hourly monitored environment with temperature of 22°C and with a humidity of 40-70%.
Animals were exposed to artificial light for 12 hours daily, Music/light period.
Diet: Pelleted standard Kliba 341, Batch 11/85 rabbit maintenance diet (Kliba, Klingentalmuehle AG, Kaiseraugst CH) was fed ad libitum. The food was analysed and the results of contaminats are attached to the study report.
Water: community tap water from Itingen ad libitum. The water was analysed and the results are attached to the study report.
Vehicle:
unchanged (no vehicle)
Controls:
other: the right eye serves as control
Amount / concentration applied:
0.1 g of the test substance
Duration of treatment / exposure:
no data
Observation period (in vivo):
up to 14 days
Number of animals or in vitro replicates:
2 males / 1 females
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
male and female
Time point:
24/48/72 h
Score:
1
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
other: no effects
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Remarks:
male
Time point:
24/48/72 h
Score:
1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal: 66
Remarks:
female
Time point:
24/48/72 h
Score:
1.7
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
chemosis
Basis:
animal: 64
Remarks:
male
Time point:
24/48/72 h
Score:
0.7
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
chemosis
Basis:
animal: 65
Remarks:
male
Time point:
24/48/72 h
Score:
1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
chemosis
Basis:
animal: 66
Remarks:
female
Time point:
24/48/72 h
Score:
1.7
Reversibility:
fully reversible
Irritant / corrosive response data:
No corrosion of cornea was observed at any of the measuring intervals.
Other effects:
Coloration: in the area of application a clear visible brownish disocloration of the cornea and conjunctivae was observed which could be related to the color of the test article.
Toxic symptoms / mortality: no acute symptoms were observed during the test period and no mortality occurred.
Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
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 a tested substance with a higher content of active ingredient.

Justification for selection of eye irritation endpoint:
The study was the most complete and assessed the effect on cornea, iris and conjunctiva.

Effect level: empty

Endpoint conclusion: Adverse effect observed

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