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Diss Factsheets

Administrative data

Description of key information

PR176

The test item did not reveal any irritation potential on the skin of rabbits, tested in this study according to OECD test guideline no. 404 and GLP conditions.

The test item did not induce significant or irreversible damage to the rabbit eye in this study according to OECD test guideline no. 405 and GLP conditions.

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:
From 19 APR 2006 to 04 MAY 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD TG 404) performed under GLP
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland GmbH, Kisslegg, Germany
- Age at study initiation: 11-12 weeks
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls.
- Diet: Pelleted standard Provimi Kliba 3418 rabbit maintenance diet (batch no. 85/05; provided by Provimi Kliba AG, CH-4303 Kaiseraugst); ad libitum
- Water: Community tap water from Füllinsdorf, ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g/animal moistened with appr. 0.5 mL purified water
VEHICLE
- Amount applied: 0.5 mL/animal
Duration of treatment / exposure:
4 h
Observation period:
10 days
Number of animals:
3 (1 male, 2 females)
Details on study design:
TEST SITE
- Area of exposure: 4 cm x 4 cm

REMOVAL OF TEST SUBSTANCE
- Washing (if done): flushed with lukewarm tap water
- Time after start of exposure: 4 h

SCORING SYSTEM:
Grading of Skin Reactions according to COMMISSION DIRECTIVE 2004/73/EC, APRIL 29, 2004
ERYTHEMA AND ESCHAR FORMATION
No erythema...................................................................................................................................0
Very slight erythema.....................................................................................................................1
Well-defined erythema..................................................................................................................2
Moderate to severe erythema......................................................................................................3
Severe erythema (beef redness) or eschar formation
(injuries in depth preventing erythema) reading.....................................................................4

OEDEMA FORMATION
No oedema......................................................................................................................................0
Very slight oedema (barely perceptible)....................................................................................1
Slight oedema (edges of area well-defined by definite raising).............................................2
Moderate oedema (edges raised approximately 1 mm)..........................................................3
Severe oedema (raised more than 1 mm and extending beyond the area of exposure)...4
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Slight to marked red staining of the treated skin area produced by the colour of the test item was noted in all animals from the 1- to the 48-hour reading and persisted in two animals up to the 72-hour or 7-day reading, respectively.
The grading of the erythema was not possible in all animals at the 1- hour reading because of the staining produced by the test item. At later time points no erythema were detectable (score 0). No edema were visible at any point of time (score 0 at all readings).
Interpretation of results:
not irritating
Conclusions:
The test item did not reveal any irritation potential on the skin of rabbits, tested in this study according to OECD test guideline no. 404 and GLP conditions.
Executive summary:

The skin irritating potential of the test item was assessed according to OECD TG 404. Three rabbits were exposed to 0.5 mg test item under semi-occlusive conditions. Slight to marked red staining of the treated skin area produced by the colour of the test item was noted in all animals from the 1- to the 48-hour reading and persisted in two animals up to the 72-hour or 7-day reading, respectively.

The grading of the erythema was not possible in all animals at the 1- hour reading because of the staining produced by the test item. When the skin was assessable, the test item did not elicit any skin reactions at the application site of any animal at any of the observation times (all scores 0). The individual mean score for erythema/eschar and oedema for each of the three animals was therefore 0. No abnormal findings were observed on the treated skin of any animal 10 days after treatment.

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:
2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD TG 405) performed under GLP
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harlan France, Gannat, France
- Age at study initiation: 15-16 weeks (male and females)
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls.
- Diet: Pelleted standard Provimi Kliba 3418 rabbit maintenance diet (batch no. 85/05; provided by Provimi Kliba AG, CH-4303 Kaiseraugst); ad libitum
- Water: Community tap water from Füllinsdorf, ad libitum
- Acclimation period: at least 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as control
Amount / concentration applied:
0.1 g
Duration of treatment / exposure:
single application, the treated eyes were not rinsed after instillation
Observation period (in vivo):
10 days
Number of animals or in vitro replicates:
3 (1 male, 2 females)
Details on study design:
SCORING SYSTEM:
Grading of Ocular Lesions according to COMMISSION DIRECTIVE 2004/73/EC, APRIL 29, 2004; comparable to Draize system

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

IRIS
Normal...........................................................................................................................................0
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)...................................................................................................1
No reaction to light, hemorrhage, gross destruction (any or all of these)........................2

CONJUNCTIVAE
Redness (refers to most severe reading of palpebral and bulbar conjunctivae when compared with control eye)
Blood vessels normal.................................................................................................................0
Some blood vessels definitely hyperemic (injected).............................................................1
Diffuse, crimson color, individual vessels not easily discernible.......................................2
Diffuse beefy red........................................................................................................................3

Chemosis: lids and/or nictitating membranes
No swelling..................................................................................................................................0
Any swelling above normal (including nictitating membranes).........................................1
Obvious swelling with partial eversion of lids.......................................................................2
Swelling with lids about half-closed........................................................................................3
Swelling with lids more than half-closed................................................................................4

TOOL USED TO ASSESS SCORE:
Eye examinations were made with a Varta Cliptrix diagnostic-lamp (Roth AG, Reinach/Switzerland).
Irritation parameter:
cornea opacity score
Basis:
animal: #1 and #2 each
Time point:
other: mean of 24-48-72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: mean of 24-48-72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24-48-72
Score:
0
Max. score:
2
Reversibility:
other: reversibility not applicable
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Time point:
other: mean of 24-48-72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal: #1 and #3 each
Time point:
other: mmean of 24-48-72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 10 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24-48-72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Irritant / corrosive response data:
The individual mean scores for iris were 0.00 for all three animals. The individual mean scores for corneal opacity were 0.00, 0.00 and 0.33, respectively. The individual mean scores for the conjunctivae were 1.00, 0.33 and 1.00 for reddening and 0.00 for chemosis for all three animals, respectively. No abnormal findings were observed in the iris of any animal at any of the measurement intervals. Very slight corneal opacity affecting the whole area was observed in all animals 1 hour after treatment and persisted in one animal until the 24-hour reading. Slight to moderate reddening of the conjunctivae was noted in all animals at the 1-hour reading and persisted as slight reddening until the 24-, 72-hour or 7-day reading, respectively. Slight swelling of the conjunctivae was noted in one animal at the 1-hour reading. Slight to moderate reddening of the sclerae was present in all animals at the 1-hour reading and persisted as slight reddening until the 48-hour reading in one animal and until the 72- hour reading in two animals. Slight to moderate ocular discharge was noted in all animals 1 hour after treatment and persisted as slight discharge in one animal until the 24-hour reading. No abnormal findings were observed in the treated eye of any animal 10 days after treatment, the end of the observation period in all animals.
Other effects:
No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.
Interpretation of results:
GHS criteria not met
Conclusions:
The test item did not induce significant or irreversible damage to the rabbit eye in this study according to OECD test guideline no. 405 and GLP conditions.
Executive summary:

The eye irritating potential of the test item was assessed according to OECD TG 405. Three rabbits were exposed to 100 mg test item. The mean score was calculated across 3 scoring times (24, 48 and 72 hours after instillation) for each animal for corneal opacity, iris, redness and chemosis of the conjunctivae, separately. The individual mean scores for iris were 0.00 for all three animals. The individual mean scores for corneal opacity were 0.00, 0.00 and 0.33, respectively. The individual mean scores for the conjunctivae were 1.00, 0.33 and 1.00 for reddening and 0.00 for chemosis for all three animals, respectively. No abnormal findings were observed in the iris of any animal at any of the measurement intervals. Very slight corneal opacity affecting the whole area was observed in all animals 1 hour after treatment and persisted in one animal until the 24-hour reading. Slight to moderate reddening of the conjunctivae was noted in all animals at the 1-hour reading and persisted as slight reddening until the 24-, 72-hour or 7-day reading, respectively. Slight swelling of the conjunctivae was noted in one animal at the 1-hour reading. Slight to moderate reddening of the sclerae was present in all animals at the 1-hour reading and persisted as slight reddening until the 48-hour reading in one animal and until the 72- hour reading in two animals. Slight to moderate ocular discharge was noted in all animals 1 hour after treatment and persisted as slight discharge in one animal until the 24-hour reading. No abnormal findings were observed in the treated eye of any animal 10 days after treatment, the end of the observation period in all animals.

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

No classification for skin and eye irritation. No adverse effects observed.