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Administrative data

Description of key information

Not irritant to rabbit skin.

Not irritant to rabbit eye.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
From July 18 to 27, 2000
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Complete read-across justification is attached in section 13. Source study has reliability 1.
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1992
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
1992
GLP compliance:
yes (incl. certificate)
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Elevage Scientifique des Dombes, F-01400 Chatillon sur Chalaronne, France
- Age at study initiation: 14 weeks (males), 13 weeks (females)
- Weight at study initiation: 2.4 to 2.7 kg
- Housing: individually in stainless steel cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 6 days under laboratory conditions, after health examination

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 45 - 70 %
- Air changes: 10 - 15 per h
- Photoperiod: 12 h light and 12 h dark

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g moistened with bi-distilled water
Duration of treatment / exposure:
4 hours.
Observation period:
Up to 72 hours after treatment.
Number of animals:
2 females and 1 male.
Details on study design:
TEST SITE
- Area of exposure: ca. 6 cm2
- Type of coverage: semi-occlusive
- Type of wrap: dressing wrapped around the abdomen and anchored with tape

REMOVAL OF TEST SUBSTANCE
- Washing: with lukewarm tap water
- Time after start of exposure: 4 h

OBSERVATION TIME POINTS: 1h, 24 h, 48 h, 72 h

SCORING SYSTEM:
ERYTHEMA AND ESCHAR FORMATION
0 No erythema
1 Very slight erythema
2 Well-defined erythema
3 Moderate to severe erythema
4 Severe erythema (beet redness) or eschar formation (injuries in depth preventing erythema) reading

OEDEMA FORMATION
0 No oedema
1 Very slight oedema (barely perceptible)
2 Slight oedema (edges of area well-defined by definite raising)
3 Moderate oedema (edges raised approximately 1 mm)
4 Severe oedema (raised more than 1 mm and extending beyond the area of exposure)
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Other effects:
- Mortality/clinical signs: no clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.
- Irritation: test article did not elicit any skin reactions at the application site at any of the observation times (all scores 0). The mean values from 24 to 72 hours were therefore 0 for erythema and 0 for oedema.
- Coloration: no staining by the test item of the treated skin was observed.
- Corrosion: no irreversible alterations of the treated skin were observed nor were corrosive effects evident on the skin.
- Body weights: body weights of all rabbits were considered to be within the normal range of variability.
Interpretation of results:
other: Non classified according to the CLP Regulation (EC 1272/2008)
Conclusions:
Non irritant to the rabbits skin.
Executive summary:

Method

Skin irritation study carried out according to OECD guideline 404. Semicocclusive application of 0.5 g of test substance applied on clipped intact skin of 3 rabbits (2 F and 1 M) for 4 hours. Treated skin was washed and observed for signs of oedema and erythema at 1 h, 24 h, 48 h and 72 h.

Results

No signs of skin irritation and no staining were noted.

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:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
From August 8 to 22, 2000
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Complete read-across justification is attached in section 13. Source study has reliability 1.
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1987
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
1992
GLP compliance:
yes (incl. certificate)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Elevage Scientifique des Dombes, F-01400 Chatillon sur Chalaronne, France
- Age at study initiation: 15 weeks (males), 14 weeks (females)
- Weight at study initiation: 2.8 to 3.2 kg
- Housing: individually in stainless steel cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 6 to 7 days under laboratoy conditions after health examination

ENVIRONMENTAL CONDITIONS
- Temperature: 22 - 23.5 °C
- Humidity: 44 - 79 %
- Air changes: 10 - 15 per h
- Photoperiod: 12 h light and 12 h dark

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 g.
Duration of treatment / exposure:
Eye non rinsed after instillation.
Observation period (in vivo):
Up to 7 days after application.
Number of animals or in vitro replicates:
2 females and 1 male.
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: no

SCORING SYSTEM:
CORNEA
Opacity: degree of density (area most dense taken for reading)
0 No ulceration or opacity
1 Scattered or diffuse areas of opacity (other than slight dulling of normal luster), details of iris clearly visible
2 Easily discernible translucent area, details of iris slightly obscured
3 Nacreous area, no details of iris visible, size of pupil barely discernible
4 Opaque cornea, iris not discernible through the opacity

IRIS
0 Normal
1 Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperemia, or injection, any of these or combination of any thereof, iris still reacting to light (sluggish reaction is positive)
2 No reaction to light, hemorrhage, gross destruction (any or all of these)

CONJUNCTIVAE
Redness (refers to most severe reading of palpebral and bulbar conjunctivae when compared with control eye)
0 Blood vessels normal
1 Some blood vessels definitely hyperemic (injected)
2 Diffuse, crimson color, individual vessels not easily discernible
3 Diffuse beefy red
Chemosis: lids and/or nictitating membranes
0 No swelling
1 Any swelling above normal (including nictitating membranes)
2 Obvious swelling with partial eversion of lids
3 Swelling with lids about half-closed
4 Swelling with lids more than half-closed

TOOL USED TO ASSESS SCORE: Varta Cliptrix diagnostic-lamp
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal: #1 and #2
Time point:
24/48/72 h
Score:
0.67
Max. score:
1
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.33
Max. score:
2
Reversibility:
fully reversible within: 7 d
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal: #2 and #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 h
Other effects:
- Mortality and clinical signs: no clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.
- Irritation: no corneal and iridal effects were observed. Slight to moderate redness of the conjunctivae and/or nictitating membrane was recorded for all animals from 1 to 48 hours after treatment. The redness diminished and cleared in two animals at 72 hours and in the third animal by day 7. Moderate (obvious, with partial eversion of the lids) swelling was seen in two animals at the 1-hour examination and decreased at 24 hours before disappearing at 48 hours. Moderate reddening of the sclera was observed in all animals at the 1-hour examination. The scleral redness diminished to slight at 24 hours and cleared in one animal by 48 hours and in two animals by 72 hours. A slight watery discharge was noted in one animal at the 1-hour reading. All eye reactions were clear within 7 days after treatment.
- Coloration: no staining of the treated eyes by the test item was observed. Yellow remnants of the test item were seen in the treated eyes of all animals at the 1-hour examination.
- Corrosion: no corrosion of the cornea was observed at any of the reading times.
- Body weights: body weights of all rabbits were considered to be within the normal range of variability.

Eye irritation scores - individual values

animal evaluation time corneal opacity iris conjunctivae
redness chemosis
M 1 h 0 0 1 0
F 0 0 2 2
F 0 0 2 2
M 24 h 0 0 1 0
F 0 0 1 1
F 0 0 2 1
M 48 h 0 0 1 0
F 0 0 1 0
F 0 0 1 0
M 72 h 0 0 0 0
F 0 0 0 0
F 0 0 1 0
M 7 d 0 0 0 0
F 0 0 0 0
F 0 0 0 0
Interpretation of results:
other: Not classified according to the CLP Regulation (EC 1272/2008)
Conclusions:
Not irritant to the rabbit eye.
Executive summary:

Method

Eye irritation study carried out according to OECD guideline 405. Instillation of 0.1 g of test substance into one eye of 3 rabbits (2 F and 1 M). The eye was not rinsed and and scoring for effects was done 1, 24, 48, 72 h and 7 d after application.

Results

No signs of corneal opacity and iris lesions were noted. Slight to moderate redness of the conjunctivae and/or nictitating membrane was noted for all animals up to 48 h after treatment. The redness diminished and cleared in two animals at 72 h and in the third animal by day 7. Moderate (obvious, with partial eversion of the lids) swelling was seen in two animals at the 1-hour examination and decreased at 24 hours before disappearing at 48 hours. A slight watery discharge was noted in one animal at the 1-hour reading.

No staining of the treated eyes by the test item was observed. Yellow remnants of the test item were seen in the treated eyes of all animals at the 1-hour examination.

No corrosion was observed at any of the measuring intervals.

All eye reactions were clear within 7 days after treatment.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Skin Irritation

Under the test condition, no signs of irritation were observed, thus no classification applied.

Eye Irritation

The substance did not show any effect on eye, thus no classification applied.