Registration Dossier

Administrative data

Description of key information

SKIN

The test material was determined to be non-irritating according to a study performed in line with OECD Guideline 404 and EPA Guideline OPP 81-5.

EYE

The test material was determined to be non-irritating according to a study performed in line with OECD Guideline 405 and EPA Guideline OPP 81-4.

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:
03 June 1985 to 06 June 1985
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
(three animals instead of six used)
Qualifier:
according to
Guideline:
EPA OPP 81-5 (Acute Dermal Irritation)
Deviations:
yes
Remarks:
(three animals instead of six used)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.0-2.5 kg
- Housing: stainless steel wire cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 11 days

ENVIRONMENTAL CONDITIONS
- Temperature: 18-20 °C
- Humidity: 685-85 %
- Air changes: 16 times per hour
- Photoperiod: 12 hours light/12 hours dark
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Remarks:
test material moistened with 1 % tragacanth suspension
Controls:
no
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
Three
Details on study design:
TEST SITE
- Type of wrap if used: 6 cm^2 aluminium foil patch

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4 hours

SCORING SYSTEM:
Erythema and eschar formation
No erythema - 0
Very slight erythema (barely perceptible) - 1
Well-defined erythema - 2
Moderate to severe erythema - 3
Severe erythema (beet redness); eschar formation (injuries in depth) - 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 (raised approximately 1 mm) - 3
Severe oedema (raised more than 1 mm, extending beyond the area of exposure) - 4
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No erythema or oedema was noted during the exposure or during the 72-hour observation period.
Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of the test, the test material was determined to be non-irritating.
Executive summary:

In a GLP compliant skin irritation study conducted in line with standardised guidelines OECD 404 and EPA OPP 85-1, the skin irritation of the test material was determined.

Under the conditions of the test, the test material was determined to be non-irritating.

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:
25 April 1983 to 02 May 1983
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
(three animals instead of six used)
Qualifier:
according to
Guideline:
EPA OPP 81-4 (Acute Eye Irritation)
Deviations:
yes
Remarks:
(three animals instead of six used)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.5-3.0 kg
- Housing: individually in stainless steel wire cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 15 days

ENVIRONMENTAL CONDITIONS
- Temperature: 19-21 °C
- Humidity: 60-80 %
- Air changes (per hr): 16 times per hours
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1 g
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
Three
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM:
Cornea
A. Opacity-degree of density
No ulceration or opacity - 0
Scattered or diffuse areas; details if iris clearly visible - 1
Easily discernible translucent areas, details of iris slightly obscured - 2
Opalescent areas of opacity, no details of iris visible, size of pupil barely discernible - 3
Opaque, iris invisible -4

B. Area of cornea involved
No damaged cornea - 0
One quarter (or less) but not zero - 1
Greater than one quarter but less than one half - 2
Greater than one half less than three quarters - 3
Greater than three quarters up to whole area - 4

Iris
Normal - 0
Folds above normal, congestion, swelling, circumcorneal injection (any one or all of these or combination of any thereof), iris still reacting to light (sluggish reaction is positive) - 1
No reaction to light, haemorrhage, gross destruction (any one or all of these) - 2

Conjunctiva
A. Redness
Vessels normal - 0
Vessels definitely injected above normal - 1
More diffuse, deeper crimson read, individual vessels not easily discernible - 2
Diffuse beefy red - 3

B. Chemosis
No swelling - 0
Any swelling above normal - 1
Obvious swelling with partial eversion of the lids - 2
Swelling with lids about half closed - 3
Swelling with lids about half closed to completely closed - 4

C. Discharge
Normal - 0
Any amount different from normal (does not include small amount observed in inner canthus of normal animals) - 1
Discharge with moistening of the lids and hairs just adjacent to the lids - 2
Discharge with moistening of the lids and considerable area around the eye - 3
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No effects were observed on cornea, iris or conjunctiva.
Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of the test, the test material was determined to be non-irritating.
Executive summary:

In a GLP compliant eye irritation study conducted in line with standardised guidelines OECD 405 and EPA OPP 81-4, the eye irritation of the test material was determined.

Under the conditions of the test, the test material was determined to be non-irritating.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin

The key study (Koopman, 1985) was performed in line with GLP and standardised guidelines with a sufficient level of detail to assess the quality of the study. The study was performed to a good standard and was assigned a reliability score of 1 using the principle for assessing data quality as set out in Klimisch (1997).

Eye

The key study (Koopman, 1983) was performed in line with GLP and standardised guidelines with a sufficient level of detail to assess the quality of the study. The study was performed to a good standard and was assigned a reliability score of 1 using the principle for assessing data quality as set out in Klimisch (1997).

Justification for classification or non-classification

In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No 1272/2008, the substance does not require classification with respect to skin and eye corrosion or irritation.